Body tissue radiofrequency applicator element, wearable device and use thereof

Abstract

The present invention relates to novel body tissue radiofrequency applicator elements (50), referred to as BTRFA elements, as well as to a wearable device useful for therapy or wellness. Body tissue RF applicator elements (50) are configured for emitting one or more electromagnetic signals in a frequency ranging from 30 MHz to 1000 MHz, said applicator element (50) being divided into at least two sections or halves (70, 70') located on either side of a central connector element (9), wherein each of said at least two sections or halves (70, 70') comprises at least two segments (70A, 70B, 70C, 70D), each of said segments comprising one or more meander structures (5).

Description

[0001] BODY TISSUE RADIOFREQUENCY APPLICATOR ELEMENT, WEARABLE DEVICE AND USE THEREOF

[0002] FIELD OF THE INVENTION

[0003] The present invention relates to body-tissue radiofrequency applicator (BTRFA) elements configured to emit pulsed RF waves, alone or in combination with photobiomodulation in the red and / or near-infrared (NIR) spectrum, to targeted body tissues. In general, the BTRFA elements may form part of wearable devices adapted to different anatomical regions of the human body and configured to provide controlled exposure to RF energy with optional synchronized red / NIR light. The invention also provides non-invasive medical head-worn devices incorporating one or more BTRFA elements for treating, preventing, stabilizing and / or reversing symptoms of dementia and neurodegenerative diseases such as Alzheimer’s disease, mild cognitive impairment, cerebral amyloid angiopathy, Parkinson’s disease, Lewy body dementia, vascular dementia and / or frontotemporal dementia in a subject in need thereof. The head device is also useful for treating, preventing and / or alleviating traumatic brain injury (TBI), concussions and other neurological conditions, as well as for treating, preventing and / or mitigating depression, migraine headaches, myodesopsia and / or tinnitus in a subject in need thereof. Finally, the invention relates to a non-invasive wellness wearable device comprising one or more BTRFA elements and intended for general wellness purposes, in particular for relieving headaches and signs of fatigue and / or enhancing general mental and cognitive abilities.

[0004] BACKGROUND OF THE INVENTION

[0005] Several types of dementia are linked to neurodegenerative proteinopathies - diseases characterized by the accumulation of misfolded proteins in the brain. These changes disrupt the normal functioning of nerve cells and their connections, leading to their gradual degeneration. Alzheimer’s disease and Parkinson’s disease are among the most common neurodegenerative proteinopathies. While these conditions share some underlying pathological mechanisms, the specific psychological and physiological symptoms vary depending on the affected brain regions.

[0006] Currently, there are no cures for these neurodegenerative diseases. Most available drugs have proven ineffective, as they neither improve nor prevent the symptoms associated with these disorders. Additionally, many treatments fail to cross the blood-brain barrier or have been found to be toxic. As a result, current medical interventions focus primarily on alleviating symptoms rather than addressing the underlying disease.Several non-drug approaches have been explored, including non-invasive brain stimulation (NIBS) and deep brain stimulation (DBS). NIBS encompasses a range of technologies and techniques that use various patterns of electrical, magnetic, electromagnetic, sound, red, and / or near-infrared (NIR) stimulation transcranially - meaning noninvasively, through the scalp — to modify brain activity and influence large-scale neural networks. These techniques do not require breaking the skin and are designed to alter brain function from the surface. NIBS includes methods such as electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS), repetitive transcranial magnetic stimulation (rTMS), transcranial alternating current stimulation (tACS), cranial electrotherapy stimulation (CES), transcranial direct current stimulation (tDCS), transcranial electromagnetic treatment (TEMT), repeated electromagnetic field shock (REMFS), and photobiomodulation (PBM).

[0007] One of the key challenges with NIBS-based medical devices is that their components - such as coils, antennas, lasers, or LEDs, which generate electrical, magnetic, electromagnetic, or red / NIR stimulation signals - are often not designed for efficient transcranial administration in humans. These components tend to be too large and bulky fortheaverage human head, failing to provide precise cortical targeting or sufficient signal penetration within the cortex. The size and shape of the antennas and coils in current NIBS head devices are not conducive to regular, convenient use, particularly in home settings. As a result, many existing NIBS devices are large, cumbersome apparatuses that require patients to visit hospitals regularly for transcranial brain stimulation treatments. This is not only inconvenient but often impractical for patients suffering from neurodegenerative diseases, who may find it difficult or even impossible to access such treatments on a regular basis.

[0008] Another challenge is that the components of NIBS-based medical devices must efficiently deliver energy into human tissue, such as the head, while ensuring homogeneous distribution and sufficient depth of penetration into the target structures. To address this, the applicators have been specifically designed to be larger, allowing them to span across the head and cover a broader area of tissue. This increased size enhances energy delivery uniformity and ensures optimal interaction with deeper structures. Additionally, these components must be adaptable to the curvature of body tissues, whether it is the human head or other similarly sized anatomical regions, without compromising power efficiency or minimizing energy emission into free space. This is particularly important when targeting the brain or other comparable body tissues for therapeutic applications.

[0009] The present invention provides novel radio frequency (RF) body tissue applicators as well as medical and wellness wearable devices that effectively and reliably deliver one or more homogeneous electromagnetic signals at various frequencies ranging from 30MHz to 1500 MHz to a human tissue, such as the head and brain, the abdomen, the back, legs, or any otherpart of the human body. More particularly, the medical and wellness devices of the present invention are useful for delivering one or more homogeneous electromagnetic signals at various frequencies ranging from 30MHz to 1500 MHz with high efficiency in terms of absorption and penetration within a human head and the brain. These novel RF tissue applicators may be designed with an optimized shape and size for non-invasive brain stimulation of the targeted part of the human body. In the case of neuromodulation, they are large enough to span across the head while adapting to different head sizes and shapes, ensuring a deep and homogeneous transcranial RF signal the subject’s cortex and to brain cells, despite anatomical variations. These applicators can be seamlessly integrated into wearable head devices such as headsets, headgear, or compact headcaps. The device is not only lightweight but also suitable for regular home use, making it accessible for long-term therapy. These novel RF tissue applicators and wearable head wearable devices are particularly useful for stabilizing and potentially reversing the symptoms of neurodegenerative diseases and proteinopathies, such as Alzheimer’s disease and Parkinson’s disease.

[0010] SUMMARY OF THE INVENTION

[0011] In one aspect, the present invention provides novel body tissue radiofrequency applicator (BTRFA) elements and non-invasive medical or wellness wearable devices comprising said one or more of said body tissue radiofrequency applicator elements which are specifically designed for directly administering one or more homogeneous pulsed electromagnetic signals to a specific body tissue, such as the head, the abdomen, the back, legs, or any other part of the human body in the need thereof.

[0012] The present invention also provides a novel non-invasive medical or wellness wearable device comprising a synergistic combination of the body tissue radio frequency applicators with low-level lasers (LLLs) and / or light-emitting diodes LEDs for simultaneous or consecutive emissions and direct administrations of one or more signals of pulsed or continuous electromagnetic waves in combination with pulsed or continuous red and near-infrared lights or signals.

[0013] The non-invasive wearable medical device according to the present invention may be adapted to the form of the human body tissues, e.g., head, abdomen, back, legs, etc... which is targeted. In the case of transcranial neuromodulation, the medical or wellness device is preferably in the form of a head-mounted wearable non-invasive device which may be placed on the head, in direct contact with the scalp and / or skull of a subject, thereby allowing homogeneous and reliable exposure of the cortex of the subject to said electromagnetic waves at one or more frequencies with or without red and near-infrared signals or lights.Novel body tissue radiofrequency applicators and non-invasive medical head devices according to the present invention are particularly useful for treating and / or preventing neurodegenerative diseases as well as for stabilizing and / or reversing the symptoms of neurodegenerative diseases such as Alzheimer’s disease, mild cognitive Impairment (MCI), Parkinson’s disease, cerebral amyloid angiopathy, dementia with Lewy bodies (DLB), and frontotemporal dementia in a subject in the need thereof. The novel body tissue radiofrequency applicators and / or non-invasive medical head devices are also useful for treating and / or preventing and / or alleviating symptoms of traumatic brain injury (TBI), concussions (mild TBI) and other types of neurological conditions in a subject in the need thereof. Furthermore, they are useful for preventing and / or reducing or eliminating depression or the symptoms of depression, delaying, reducing and / or eliminating depression and its symptoms, reducing and / or relieving migraines, reducing and / or mitigating myodesopsia and vitreous opacities, and / or tinnitus (hardness of hearing) in a subject in the need thereof. Finally, the novel body tissue radiofrequency applicators and / or non-invasive head device according to the present invention may be used by healthy human individuals for general wellness purposes, particularly for relieving headaches and signs of fatigue, and / or enhancing general mental and cognitive abilities.

[0014] BRIEF DESCRIPTION OF THE FIGURES

[0015] Figures 1A-B are schematic representations of a preferred embodiment of a substantially quadriangular shaped body tissue radiofrequency applicator element (50), hereinafter called “BTRFA”, with two mirrored sections or halves (70, 70’) each being divided into two substantially triangular segments (70A, 70B) for the first half (70) and two substantially triangular segments (70C, 70D) for the second half (70’), extending outward in a mirrored and opposing arrangement relative to a central axis. Figure 1A is a top view of the BTRFA (50) shows a dielectric layer (1), a top metal layer (2), and attachment means (3). Figure 1B is bottom view of the BTRFA (50) which is direct contact with the human body also shows the bottom conductive metal layer of the printed circuit board (“PCB”) (60) comprising meandered printed metal RF traces or RF conductors (4) with 18 meanders (5), a central connector (9) comprising several interconnecting points or pins (10), possible locations or housings (6) for mounting LEDs if any within each substantially triangular segment, a main trace (7) for connecting the LEDs to the corresponding pin of the central connector, and a metallized surface (8) surrounding the main trace (7) and forming the ground (GND).

[0016] Figures 2A-C are detailed schematic representations of specific portions of the bottom layout of the BTRFA of Figure 1B. Figure 2A is a detailed view of the bottom metal layout of one triangular segment (70A) further showing LED or SMA package for the LED (11) with theirseries resistors (12). Figure 2B is a detailed view of the LED mounting housing (6) and footprint comprising a central thermal pad (14), and pads representing anode connections (15) and cathode connections (16) on opposite side of the mounting housing (6), as well as printed traces for the LED diode (17, 18), and the series resistors (12). Figure 2C is a detailed view of a portion of the bottom of one triangular segment wherein one LED or SMA package of the LED diode (11) is mounted, while showing one empty LED mounting housing (6) thus showing the central thermal pad (14), as well as the attachment means (3) on each side.

[0017] Figures 3A-C: Figure 3A is a schematic representation of the central part of the BTRFA with four connection points A1 , A2, B1 , B2 to which the RF excitation signal is applied. Figure 3B is a detailed view of the top layout of the interconnecting pins within the central connector (9) of the BTRFA showing central connectors or vias (21) allowing connecting the BTRFA to a generator, additional vias (22) on each side of the central connectors (21), and the metallized grounded vias (23). Figure 3C is a view of the bottom layout of the interconnecting pins within the central connector (9) of the BTRFA also showing central connectors or vias (21) allowing connecting the BTRFA to a generator, additional vias (22) on each side of the central connectors (21), and the metallized grounded vias (23).

[0018] Figures 4A-B are detailed schematic representations of the central connecting structure or the central connector (9) of the BTRFA with 16 interconnecting pins (10) for connecting the BTRFA. A is a top view and B is a bottom view.

[0019] Figure 5 is a schematic representation of an adjustable attachment mechanisms (3) comprising interlocking structures for BTRFAs, enabling the curving as well as secure and adaptive placement of one or more BTRFA on a human head.

[0020] Figures 6A-B: Figures 6A and 6B show a bottom detailed view of the central coaxial connector switch (X or Y) structure (9) of a large meandered BTRFA (50) made of printed circuit board. The central PCB connection shown in Figure 6A is X-type and in Figure 6B is Y-type. Both PCB connections comprise a printed circuit board comprising an RF input microstrip line (180) which brings the RF signal into the central connector (9), a first electrically conductive layer (190) on the top ground (GND) plane of the BTRFA PCB, a second electrically conductive layer (210) on the bottom ground (GND) plane (or opposite conductor layer) of the BTRFA PCB stack-up, and a dielectric layer 220 separating the first and second electrically conductive layer (190, 210). End points A1, A2, B1 and B2 of the two PCBs or wires (80) in each of the two halves (70, 70’) are connected to either an RF input microstrip line (180) or to a top GND layer (190) at the individual connection pads or points (160) on the central PCB where each points A1 , A2, B1 and B2 meets the microstrip (180) . B shows a zoomed out bottom view of the large meandered BTRFA made of PCB with the central coaxial connector switch.Figures 7A-B: Figure 7A shows the simulated S11 -parameter (scattering parameter or reflection: return loss - RL) of the X-BTRFA placed close to body tissue over the 0.3-2.0 GHz frequency range, highlighting resonance dips around 0.4, 0.95, 1.4 and 1.9 GHz. Figure 7B is a graph showing, for the same configuration, the corresponding power balance versus frequency or power distribution of X-BTRFA placed close to a body tissue, including power accepted by the X-BTRFA, power radiated, ohmic and dielectric losses, and power remaining at the ports.

[0021] Figures 8A-B: Figure 8A shows an exemplary arrangement of four substantially quadrilateral BTRFAs (50) positioned to cover the entire human head. Figure 8B shows the positioning of the frontal quadrilateral BTRFA (50), which is arranged to cover the frontal lobes of the right and left cerebral hemispheres.”

[0022] Figures 9A-B show simulated specific absorption rate (SAR) distributions produced by four substantially quadrilateral BTRFAs arranged as in Figure 8. Figure 9A presents a bottom (inferior) view of the SAR distribution within the head model, and Figure 9B presents a lateral side view.

[0023] Figure 10 shows a simulated sagittal cross-section of the absolute electric field distribution generated by the four substantially quadrilateral BTRFAs arranged as in Figure 8 at a frequency of 915 MHz. The color map indicates the electric field magnitude in dB(V / m), with a maximum value of approximately 99 dB(V / m) (about 98.9 dB(V / m) in the displayed cross-sectional plane.

[0024] Figures 11A-B are schematic representations of a head-mounted device according to the present invention. Figure 11A shows a top view of the device, with a transparent outer shell revealing the motherboard and four substantially quadrilateral BTRFAs populated with LEDs arranged around the head. Figure 11 B shows a bottom view of the device, in which an inner mesh with openings is visible, allowing the LEDs to be seen and to emit light toward the scalp Figures 12A-B are schematic representations of a head-mounted device in the form of a baseball cap. Figure 12A shows a lateral view highlighting the reduced coverage over the occipital region and the connection to an external rechargeable battery. Figure 12B shows a semi-frontal view of the same baseball-cap-shaped device worn on the head.

[0025] DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS OF THE INVENTION

[0026] According to a first aspect, the present invention provides body-tissue radiofrequency (RF) applicator elements (50) configured to apply one or more electromagnetic signals or RF fields inwardly and directly to human body tissue. These body-tissue radiofrequency applicator elements (50) are referred to hereinafter as a BTRFA in the singular and as BTRFAs in the plural.The BTRFA elements (50) are configured to emit one or more electromagnetic signals within the radiofrequency (RF) spectrum, i.e. within high-frequency bands ranging from 30 MHz to 3000 MHz, toward adjacent human tissue.

[0027] Preferably, the one or more RF or electromagnetic signals operate within a narrow frequency band chosen from 30-200 MHz, 40-100 MHz, 50-70 MHz, around 60 MHz, around 64 MHz, 850-950 MHz, 800-930 MHz, 850-915 MHz, 910-920 MHz, or around 915 MHz.

[0028] The BTRFA elements (50) may deliver continuous-wave or pulsed electromagnetic signals to adjacent body tissue. The electromagnetic signals may be pulsed with one or more repetition (pulsation) rates comprised between 10 Hz and 400 Hz. Said one or more rates of repetition of the RF signals may range from 10-300 Hz, 20-200 Hz, 40-100 Hz, or 100-200 Hz, and may in particular be around 20 Hz, 40 Hz, 100 Hz, 150 Hz, or 200 Hz.

[0029] The BTRFA elements (50) may be formed from printed circuit board (PCB) structures. The PCB structures of the BTRFA elements (50) are lightweight and may be flat, flexible and / or curved, preferably flexible or curved-flexible PCBs (“flex PCBs”) that can conform to curved anatomical surfaces of the targeted human body tissue, such as the head.

[0030] The flexible PCB (60) comprises a printed structure on a thin, flexible dielectric substrate, such as a supporting dielectric layer (1) of a thin flexible dielectric material disposed between two metal layers (or conductor surfaces) (2), one on the top side and one on the bottom side of the supporting dielectric layer (1). The bottom metal layer (2) is oriented towards the human tissue and the top metal layer (2) is oriented away from it. The bottom metal layer (2) comprises printed metal RF traces (traces of the RF conductors) (4) that form the BTRFA element (50), and emits the RF signal to the targeted human body tissue; the RF traces (4) preferably extend along the periphery of the entire BTRFA element (50) structure. Suitable thickness or widths of the printed transmission lines can be easily determined by a skilled person in the art. By way of example, the thickness of the thin metal strips may be at least 0.01 mm and the width may be at least 0.5 mm; the metal thickness may be around 0.035 mm or reduced to 0.0175 mm or even lower if the appropriate flexy PCB technology is used, while the dielectric thickness may be around 0.1 mm or even thinner.

[0031] The PCB structure (60) of a BTRFA element is dimensioned such that one or more BTRFA elements can cover part or all of the surface of the targeted human body tissue.

[0032] When the targeted body tissue is the human head, the length of the PCB structure (60) of a BTRFA element is such that a single BTRFA element may span across the head, for example to cover the frontal, parietal or occipital lobes of both hemispheres, or several lobes of a single hemisphere. A BTRFA element may have a size approximately equal to a quarter of the surface of the head to be exposed to the RF signal, to a smaller portion of that surface, or tosubstantially the whole surface of the head requiring RF exposure. One or more BTRFA elements according to the present invention can thus be arranged to cover the entire surface of the human head, thereby enabling substantially uniform coverage with a homogeneous and deep RF signal throughout the brain, if desired.

[0033] The BTRFA element (50) according to the invention comprises at least two sections or halves (70, 70’) located on opposite sides of a central connector element (9). Each section or half (70, 70’) comprises at least two segments (70A, 70B, 70C, 70D), each segment comprising a one or more meander structures (5). The halves (70, 70') may be substantially identical or distinct from one another, and the segments (70A, 70B, 70C, 70D) within a given half may likewise be substantially identical or differ in shape and / or size. The meander structures (5) within each segment (70A, 70B, 70C, 70D) may further comprise interconnecting structures (25) extending between said meander structures (5).

[0034] The BTRFA element (50) comprises at least two sections or halves (70, 70') disposed on opposite sides of the central connector element (9). The sections may have identical, similar or different geometries, and may therefore be substantially symmetric or intentionally asymmetric with respect to a first axis extending between the two sections or halves (70, 70') and through the central connector element (9), and / or with respect to a second axis extending through the central connector element (9) and perpendicular to said first axis.

[0035] Preferably, the BTRFA element (50) is generally axially symmetrical with respect to the central connector element (9) about a first axis extending between the two sections or halves (70, 70') and passing through the central connector element (9), although in other embodiments the sections may depart from exact symmetry. Preferably, the BTRFA element (50) is also generally axially symmetrical with respect to a second axis extending through the central connector element (9) and perpendicular to the axis between the two sections or halves (70, 70'), again with the possibility that the sections depart from exact symmetry in other embodiments.

[0036] The body-tissue RF applicator element (50) comprises at least two sections or halves (70, 70') positioned in a mirrored and opposite arrangement relative to a central axis. Each of the at least two sections or halves (70, 70'), located on either side of a central connector element (9), may be flat or may have, in a top view of the respective section or half (70, 70'), a substantially concave, lens-shaped outer circumference.

[0037] According to one embodiment, said sections or halves (70, 70') comprise one or more widened segments (70A, 70B, 70C, 70D) on either side of the central connector (9). In this embodiment, the widened segments (70A, 70B, 70C, 70D) of the body-tissue RF applicator element (50) comprise, in a top view of the respective section or half (70, 70'), a substantially triangular, arrow-shaped, or pointer-shaped outer circumference. In a particular embodiment, the sectionsor halves (70, 70') comprise two mutually symmetrical triangular segments (70A, 70B, 70C, 70D) positioned in a mirrored and opposite arrangement relative to the central axis.

[0038] Each section or half (70, 70’) comprises one or more elongated, tapered parts that converge toward the central connection structure (9). The at least two sections or halves (70, 70’) of the BTRFA (50) comprise one or more meanders (5) that are mutually connected and may have different geometrical configurations, which can be symmetrical or asymmetrical. The meanders may be connected by one or more interconnecting segments (25) that may also have different geometrical configurations either symmetrical or asymmetrical. The shape of the PCB structure (60) and of the RF traces (4) may be optimized either to achieve a substantially uniform distribution of RF signal and RF energy over the entire surface of the head, orto obtain a desired specific distribution of the RF signal within a selected region of the brain.

[0039] Preferably, the at least two sections or halves (70, 70'), the PCB structure (60) and the RF traces (4) comprise one or more substantially triangular or arrow-like geometrical segments (70A, 70B, 70C, 70D) with one or more meanders (5), preferably between 5 and 30, more preferably between 10 and 20 meanders (5). The two halves or sections (70, 70') are preferably positioned in a mirrored and opposing arrangement relative to a central axis. In such embodiments, the triangular or arrow-like BTRFA may comprise at least two mirrored sections or halves (70, 70') extending outward into triangular or arrow-like segments. Alternatively, the two halves (70, 70') may comprise a composite triangular array including multiple triangular segments arranged in a structured pattern.

[0040] The present invention also encompasses variations in the geometry and configuration of the segments (70A, 70B, 70C, 70D), the number of such segments, the number of meanders (5), the number of sections or halves (70, 70'), their symmetry or asymmetry, and their degree of compactness, in order to optimize the design for different target regions or areas of human body tissue and to ensure adaptability to varying anatomical structures of the targeted body tissues.

[0041] The central connector (9) comprises one or more vias (21) in which one or more interconnecting points or pins (10) are positioned and fixed (for example, by soldering), through which the RF signal from an RF generator is supplied. The central connector (9) may comprise a central dual row of vias corresponding to a central dual row of interconnecting pins or points. The number of vias and pins may range from 4 to 30, for example from 6 to 20 pins, such as 16 interconnecting pins arranged in two opposing rows of 8 pins, and may vary depending on the complexity of the BTRFA element structure.

[0042] In one embodiment, the RF signal generated in a central unit is supplied to the BTRFA element (50) through four central vias (21). The BTRFA element (50) is connected to four central interconnecting pins (10) mounted within these four central vias (21) of the central connector(9), thereby allowing the RF signal to be delivered to the BTRFA element (50) through the four central interconnecting pins (10).

[0043] The PCB (60) of each of the at least two sections or halves (70, 70') comprises first and second ends (80), each end being connected to a central connector structure (9) comprising the four central vias (21) in which the four central interconnecting points or pins (10) are mounted and to which the RF stimulatory signal is applied. The central connector structure (9) further comprises a first conductor structure (100) and a second conductor structure (110), to which the first and second ends (80) of the PCB (60) are respectively connected.

[0044] As illustrated in Figure 3A, the ends of the RF conductor traces (4) are connected to four central connections or vias (21) via endpoints denoted A1 and A2 for the PCB of each of the at least two halves or sections (70, 70'), and B1 and B2 for the PCB of the opposite half or section. The central connection (9) linking the two halves or sections of the BTRFA may be of the X-type, forming a fully criss-crossed connection of endpoints A1 to B2 and A2 to B1. In other words, the first end (80) of the PCB (60) of one half (70) and the second end (80) of the other half (70') are continuously connected across the central connector structure (90), forming a direct electrical path through the first conductor structure (100). The other, opposite ends (80) of the PCBs (60) of each half or section (70, 70') are connected to the second conductor structure (110) but do not extend unbroken across the central connector structure (90) from one half (70) to the other; instead, they preferably form an interrupted straight line, such that the connection to the outer conductor (110) remains localized to each half (70, 70') and does not establish a direct continuous path across the central connector (90). As illustrated in Figure 6A, the X-type connection is fully criss-crossed, forming an X-shaped configuration when viewed from a top perspective onto the central connector structure (90). In certain embodiments, the X-type feeding mode is configured to concentrate the RF energy deeper within the body tissue, thereby enhancing penetration depth of the electromagnetic field. Alternatively, the central connector (9) linking the two halves or sections of the BTRFA may be of the Y-type, forming a half-criss-crossed connection of endpoints A1 to B1 and A2 to B2. In other words, the first ends (80) of the PCBs (60) of each section or half (70, 70') are connected to the first conductor structure (100) and extend unbroken along a Y-shaped path from one half (70) to the other half (70'), while the second ends (80) of the PCBs (60) of each section or half (70, 70') are connected to the second conductor structure (110) but form a Y-shaped path that is interrupted by the central connector structure (90). As illustrated in Figure 6B, the Y-type connection is half-criss-crossed, forming a Y-shaped configuration when viewed from a top perspective onto the central connector structure (90). In certain embodiments, the Y-type feeding mode is configured to distribute the RF energy more broadly over the surface region of the body tissue, with comparatively reduced penetration depth.The central connector may also comprise a switching mechanism that enables transition between an X-type connection and a Y-type connection, and vice versa, without replacement of the entire BTRFA. By integrating an RF switch into the output circuit of the transmitting RF amplifier, it becomes possible to selectively establish electrical connections with the endpoints A1, A2, B1 and B2, so that these endpoints can alternately implement the X-type or Y-type feeding modes of the BTRFA, thereby selectively providing either deeper RF field penetration or predominantly surface-weighted RF field distribution within the targeted body tissue.

[0045] According to another embodiment of the invention, the BTRFA element further comprises one or more mounting locations (6) for mounting one or more low-level lasers (LLLs) and / or lightemitting diodes (LEDs) (200), said one or more mounting locations (6) being arranged substantially along a longitudinal central region of the respective section or half (70, 70').

[0046] According to this embodiment, the BTRFA element thus comprises one or more low-lever lasers (LLL) and / or light-emitting diodes (LED) (200) mounted at said mounting locations (6). Each low-level laser (LLL) and / or light-emitting diode (LED) is configured to emit in the red and / or near-infrared (NIR) spectrum. The light sources may include LEDs (200) and / or low-level laser (LLL) sources, generating one or more signals within the red and / or NIR spectral range.

[0047] The combination of one or more low-level laser (LLL) and / or light-emitting diode (LED) (200) integrated within the BTRFA elements enables synergistic administration of pulsed electromagnetic signals together with red and NIR light to human body tissue, including, for example, the human head.

[0048] The one or more low-level lasers (LLLs) and / or light-emitting diodes (LEDs) (200) are configured to emit red and / or NIR signals, with red wavelengths preferably in the range of 620-680 nm and peak wavelengths around 630 nm, 660 nm, or 670 nm. The NIR signals may comprise one or more wavelengths within 800-1100 nm, with preferred peaks around 810 nm, 830 nm, 880 nm, and within about 1060-1070 nm.

[0049] The one or more red and / or NIR low-level lasers (LLLs) and / or light-emitting diodes (LEDs) (200) may operate continuously or in alternating pulses overlapping with the pulsed RF wave emission from the BTRFA elements (50) and are preferably pulsed in temporal overlap with the pulsed RF signals. The red and NIR signals may have identical or different repetition rates, with a pulsation or repetition cycle between 10 Hz and 100 Hz, preferably between 20 Hz and 60 Hz, for example approximately 20 Hz or 40 Hz.The cycle of repetition or pulsation of the red and NIR low-level lasers (LLLs) and / or light-emitting diodes (LEDs) (200) may use a 40 Hz repetition frequency with a 50% duty cycle, in which each pulse lasts 12.5 ms followed by a 12.5 ms pause, resulting in an effective LED power consumption and heat dissipation (PC-HD) of about 50% of the maximum continuous value. Alternatively, a 20 Hz repetition frequency with a 50% duty cycle may be used, involving 25 ms pulses followed by 25 ms pauses.

[0050] In another implementation, a “wavelength-sequential” LED or LLL sequence may be employed, in which a single low-level laser (LLL) and / or light-emitting diode (LED) at a specific wavelength is activated for 25 ms followed by a 25 ms pause, while all other low-level lasers (LLL) and / or light-emitting diodes (LED) remain OFF, producing an effective repetition frequency of 10 Hz with an LED or LLL duty cycle of 25%.

[0051] Alternatively, a variation without inter-pulse pauses may be used, in which only one wavelength is active at a time for 12.5 ms, followed immediately by activation of the next wavelength. In this configuration, the repetition frequency of each low-level laser (LLL) and / or light-emitting diode (LEDs) channel is 26.67 Hz with an individual duty cycle of 33.33%, while the total LED or LLL power consumption and heat dissipation (PC-HD) corresponds to 33.33% of the maximum continuous value.

[0052] In addition, variations of the single low-level laser (LLL) and / or light-emitting diode (LED) pulse duration may be employed, provided that the duty cycle of each low-level laser (LLL) and / or light-emitting diode (LED) remains at 33.33%, the overall PC-HD remains at 33.33% of the maximum, and all BTRFA elements operate under substantially identical alternating low-level laser (LLL) and / or light-emitting diode (LED) conditions.

[0053] The electromagnetic field emitted by the BTRFA element (50) may be synchronized with the red and NIR light signals from the low-level lasers (LLLs) or light-emitting diodes (LEDs) (200) by appropriately adjusting the duty cycles within the combined BTRFA-LED system or within the combined BTRFA-LLL system. In one configuration, the BTRFA element (50) emits RF energy at 915 MHz with a 200 Hz repetition frequency and a 100% duty cycle, while the low-level lasers (LLLs) and / or light-emitting diodes (LED) (200) emit red and / or NIR light at 40 Hz with a duty cycle of about 12.5%, 10%, or 20%.

[0054] Preferred low-level lasers (LLLs) (200) are non-thermal therapeutic lasers that deliver red or near-infrared light at relatively low power and energy densities, insufficient to cut, ablate, or thermally coagulate tissue. It is typically operated in the approximate range of 5-500 mW output power (Class III “cold laser”), often with wavelengths between about 600 nm and 1000 nm, to induce photobiomodulation effects such as modulation of cellular metabolism, inflammation, and tissue repair.Preferred light-emitting diodes (LEDs) (200) comprise 3-in-1 chip LEDs incorporating three independently drivable emitters at different red and NIR wavelengths, for example 660 nm, 810 nm, and 1064 nm, operated with a pulsation rate of about 40 Hz. The LED may be provided in a Surface-Mounted Assembly (SMA) package (11), / .e., an assembly designed for mounting directly onto a printed circuit board (PCB) using surface-mount technology.

[0055] At the input of each low-level laser (LLL) or light-emitting diode (LED) (200), a series resistor (12) is provided, the value of which defines the magnitude of the DC drive current through the diodes. Each LED diode or LLL has a footprint comprising a central thermal pad (14), which is arranged for grounding and thermal cooling of the diode housing, and three pads (15) forming the anode connections together with three pads (16) forming the cathode connections of the three chip LEDs or LLLs.

[0056] The diodes are driven in a series configuration implemented with printed traces (17, 18) that interconnect the corresponding cathode and anode pads, while the cathode connection of the last diode in the series is connected to ground via the central thermal pad (14).

[0057] The low-level lasers (LLLs) and / or light-emitting diodes (LEDs) (200) used in combination with the BTRFA elements (50) may operate within a power range of about 25 mW to 1 W, and preferably between approximately 50 mW and 500 mW, depending on the selected repetition frequency and duty cycle of the low-level lasers and / or light-emitting diodes (LED) (200). By way of example, a 3-in- 1 LED having a nominal peak power of about 455 mW driven with a pulsed signal at a duty cycle of 0.125 results in an average optical power of roughly 57 mW, which may be adjusted to other values by changing the duty cycle; for instance, increasing the duty cycle so that the time-averaged output is about 100 mW.

[0058] The beam spot sizes of the low-level lasers low-level lasers (LLLs) and / or light-emitting diodes (LEDs) (200) may range from about 0.1 cm2to 1 cm2, with a preferred power density (irradiance) between roughly 10 mW / cm2and 100 mW / cm2, more preferably around 50 mW / cm2. Each low-level laser (LLL) and / or light-emitting diode (LED) (200) preferably delivers a total energy in the range of about 1-50 J, preferably around 25-30 J per LED.

[0059] The fluence (energy density) per low-level laser (LLL) and / or light-emitting diode (LED) (200) is preferably between approximately 5 J / cm2and 200 J / cm2, more preferably around 100 J / cm2. The total dose per treatment session, calculated as the fluence per low-level laser (LLL) and / or light-emitting diode (LED) (200) multiplied by the number of low-level lasers (LLLs) and / or light-emitting diodes (LEDs) (200), may therefore fall within about 2000-7000 J / cm2, preferably 3000-6000 J / cm2, and even more preferably around 5000 J / cm2.

[0060] Said one or more low-level lasers (LLLs) and / or light-emitting diodes (LEDs) (200) - or an array of such LLLs or LEDs (200) emitting red and / or NIR signals - may be embedded or integrated within the structural framework of the BTRFA element (50). They may be mounted on thebottom metal layer (2), within a central region of the one or more segments forming each of the halves (70, 70') of the BTRFA.

[0061] Each BTRFA element (50) can thus be combined with low-level lasers (LLLs) and / or light-emitting diodes (LEDs) (200) emitting red and / or NIR light, and each segment may comprise one or more locations (6) for mounting the low-level lasers (LLLs) and / or light-emitting diodes (LEDs) (200). Each BTRFA element (50) may comprise between 1 and 200 LLLs and / or LEDs, between 8 and 100 LLLs and / or LEDs, between 10 and 50 LLLs and / or LEDs, or between 10 and 30 LLLs and / or LEDs per element, preferably around 24 LLLs and / or LEDs per element, with corresponding numbers of locations (6) provided on the segments for LLL and / or LED mounting. Depending on the number of halves (70, 70') and the number of segments per BTRFA element, each segment may comprise the required number of locations (6) for mounting the LLLs and / or LEDs, for example between 2 and 12, between 4 and 8, or about 6 locations per segment.

[0062] By way of example, Figure 1 illustrates a substantially quadriangular BTRFA element (50) comprising locations for mounting a total of 24 LEDs (200) per unit, i.e. six LEDs on each segment. This example shows how the LEDs may be embedded within the BTRFA element structure to ensure suitable placement for delivering pulsed electromagnetic signals together with red and / or NIR light to the intended human body tissue treatment area.

[0063] When the BTRFA element is combined with LEDs, the central connector (9) may further comprise additional vias in which interconnecting pins or contact points are mounted for supplying the DC voltages used to bias the LEDs (200). Through four additional vias (22), each fitted with an interconnecting pin (two for each half-section of the BTRFA), a positive DC supply voltage can be delivered to the LED diodes, each via (22) and corresponding pin feeding one group of LEDs located within a respective segment of the BTRFA.

[0064] The central connector (9) may further include grounding vias (23), which are tied to the common ground of the PCB and used to provide the negative DC return for powering the LED diodes.

[0065] As described above, the RF signals for the BTRFA elements may be delivered through four central interconnecting pins or points of the central connector (9), the positive DC voltage for LED and / or LLL biasing may be supplied through the next two pairs of pins, and the LED and / or LLL ground return may be connected to two pairs of peripheral interconnecting pins or points. All LEDs and / or LLL may be connected in parallel to the power-supply circuitry, so some of the available mounting locations may intentionally remain unpopulated. In this configuration, the central part of the bottom layer of each segment may comprise a main trace (7) that carries the positive DC signal for LED and / or LLL polarization from the corresponding pins of the central connector (9), while this main trace (7) is surrounded by a metallized area (8) formingthe GND plane on the bottom layer, which is tied to the top-layer GND via multiple metallized grounding vias (23).

[0066] The BTRFA element may further comprise attachment means or mechanisms (3) extending outwardly from each of the segments of each half. These may take the form of spring-like elements, elastic bands, or other structures that mechanically interconnect the segments of a given BTRFA element, thereby forming a spatially curved structure and / or enabling connection to an adjacent BTRFA element, so that RF energy is distributed uniformly across the targeted brain region.

[0067] These attachment mechanisms (3) are preferably adjustable and may include one or more interlocking structures that permit customization for different head sizes, ensuring stable positioning and uniform application of RF, red and NIR energy. The design can accommodate both transverse and longitudinal orientations, allowing the applicator to be worn ear-to-ear or forehead-to-nape while maintaining consistent treatment efficacy.

[0068] Interlocking components may be provided, including a first attachment member (150A) having a serrated or ridged extension configured for incremental length adjustment, and a second attachment member (150B) having a slotted or comb-like opening configured to receive and lock the serrated extension in position. Flexible structural arms may extend outward to allow the applicator to conform to various head shapes while maintaining a snug fit, optionally in combination with spring-loaded or elastic elements that provide tension control and ensure stable electrode-skin contact without excessive pressure. Optional locking mechanisms can enable manual tightening or loosening to refine the fit. As illustrated in Figure 5, such attachment means (3) allow adjustable positioning of the BTRFA elements while ensuring stability during use, making the system suitable for different head sizes and anatomical variations.

[0069] Figure 1 illustrates an embodiment of a substantially quadriangular, dual-triangular BTRFA element (50) comprising four mutually symmetrical triangular segments and eighteen meanders (5), which define the total length of the RF traces (4) so that they fit within the available surface area of the BTRFA element and adapt to the shape and size of human heads. Figure 1A schematically shows the top layout of this BTRFA element, including the supporting dielectric central layer (1) and the metal layer (2), which, apart from the central pads around the central connector, forms the GND ground to which the negative DC signal for biasing the LEDs is connected; a corresponding GND ground is provided on the bottom layer, the two grounds being interconnected by multiple metallized grounding vias (23).

[0070] Figure 1B schematically shows the bottom layout of one BTRFA element, including the bottom metal layer (2) with the printed RF traces (4) that form the BTRFA element, the LED mounting locations (6) in each segment that allow a total of twenty-four LEDs (200) to be mounted onthe quadriangular BTRFA element, the main trace (7) surrounded by a metallized surface (8) forming the GND ground, and the central connector or central connection structure (9).

[0071] Figure 2A is a detailed schematic representation of one of the four identical, mutually symmetrical substantially triangular segments, viewed from the side of the bottom metal layer, where the LEDs in SMA (surface-mounted assembly) packages (11) are mounted. At the input of each LED package, a series resistor (12) is provided, the value of which defines the magnitude of the DC drive current, and each SMA LED contains three chip LEDs that emit light at three different wavelengths.

[0072] Figure 2B is an enlarged view of portion (13) of Figure 2A, showing the footprint for one SMA LED package with the corresponding arrangement of the central pad (14), which serves for grounding and thermal cooling of the LED housing, three pads (15) forming the anode connections of the chip LEDs, and three pads (16) forming the cathode connections. The LEDs are driven in a series configuration implemented by printed traces (17, 18) that connect the corresponding cathode and anode pads, while the cathode connection of the last LED in the series is connected to ground via the central thermal pad (14) of the LED footprint.

[0073] Figure 2C is a detailed view of a portion of one triangular segment, illustrating one mounted LED, one empty LED footprint, and attachment means (3) provided on each side.

[0074] Figures 3B and 3C show the top- and bottom-layer layouts with the signal vias at which the central pin connector is soldered. Through the four central vias (21), the RF signal generated in the central unit of the device is supplied to the BTRFA element. Through four further vias (22), a positive DC voltage for powering the LED diodes is supplied, each via (22) feeding one group of six LEDs located within a respective segment of the BTRFA element.

[0075] The remaining eight vias (23) are interconnected via the common ground of the PCB and are used to provide the negative DC return for powering the LED diodes. The first and last pairs of grounding vias (23) are redundant and may be omitted without affecting device functionality. The major function of the BTRFA, and an important aspect of the invention, is to efficiently deliver RF energy into body tissue. “Efficiently deliver” encompasses not only power efficiency, but also the ability to distribute RF energy substantially uniformly over a sufficiently large area so that, for example, the entire surface of a human head can be covered with a reasonably small number of the BTRFA elements. The BTRFA elements should further be able to conform to the curvature of the target tissue, such as the human head, without a significant loss of power efficiency. In addition, it is desirable to minimize RF energy emission into free space in order to facilitate compliance with applicable electromagnetic compatibility (EMC) requirements and regulations.The graph of the S11 -parameter (scattering or reflection parameter, i.e. return loss, RL) of the quadriangular BTRFA indicates very good impedance matching when the applicator is placed close to body tissue, with a low reflection coefficient Si, of about -16 dB (Figure 7A). At this operating point, the power-distribution graph shows that, for an input power of 0.5 W, approximately 0.4728 W is transferred into the dielectric load, corresponding to an efficiency of about 94.56% (Figure 7B).

[0076] As indicated above, BTRFA elements according to the present invention may be provided in variable shapes and sizes, adaptable to different parts of human body tissue and configured to achieve a desired coverage area and depth of exposure to the stimulatory signals used for treatment.

[0077] In addition to providing an efficient and reliable electromagnetic exposure zone, the BTRFA elements are configured to deliver a reliable, reproducible, and efficient specific absorption rate (SAR) within the targeted human brain tissue. SAR is a measure of the rate at which RF energy is absorbed per unit mass of body tissue when exposed to a radiofrequency electromagnetic field, expressed in watts per kilogram (W / kg). Preferred SAR values according to the present invention range from about 0.2 to 3 W / kg, more preferably from 0.2 to 2 W / kg or from 1 to 2 W / kg, such as 1.5 to 2 W / kg, around 1.5 W / kg, or around 2 W / kg. Preferably SAR values are around 0.4 to 0.9 W / kg.

[0078] As depicted in Figures 9A-B, the SAR distribution simulations of four BTRFA as positioned in Figure 8, provide superior, deep and uniform SAR distribution with a SAR value around 0.2 to 0.4 W / kg in deep structures of the brain.

[0079] According to a second aspect, the present invention relates to the use of BTRFA element (50) as described above for direct administration of an electromagnetic field to a targeted human tissue, and to a method of directly administering one or more electromagnetic signals to a targeted human tissue, comprising positioning the BTRFA adjacent to, or in direct contact with, the human tissue so as to allow direct delivery of said electromagnetic (RF) signals.

[0080] According to this aspect, the invention also relates to the use of BTRFA element (50) in combination with one or more low-level lasers (LLL) and / or light-emitting diodes (LEDs) (200) as described above, for direct administration of a synergistic combination of one or more pulsed electromagnetic signals and red and / or NIR light to body tissue in subjects in need of such treatment, and to a method of directly administering this synergistic combination to a targeted human tissue, comprising positioning the BTRFA-LED and / or BTRFA-LLL assemblies adjacent to, or in direct contact with, the human tissue so as to allow direct delivery of said electromagnetic field signals together with the red and / or NIR light signals.Targeted human tissues which may be treated by or exposed to such electromagnetic signals alone or in combination with red and / or NIR signals, may include any parts of the human body, such as for example and without any limitations, the human head or skull, the frontal part and / or the temporal parts, and / or the occipital part of the head, the neck, the abdomen of a human body. Preferred human body tissues comprise the human head, optionally the neck and possibly abdomen. Most preferred human body tissues comprise the human head.

[0081] BTRFA elements (50), BTRFA-LED and / or BTRFA-LLL combinations as described above are particularly useful in methods for treating, preventing, stabilizing and / or reversing symptoms of neurological disorders, including neurodegenerative diseases chosen among Alzheimer’s disease, frontotemporal dementia and variants thereof, cerebral amyloid angiopathy, Parkinson’s disease and Lewy body dementia, in a subject in need thereof. The method comprises positioning one or more BTRFA elements (50) in proximity to, or in contact with, the subject’s head and permitting direct transcranial administration of one or more electromagnetic signals, alone or in combination with red and / or NIR light, to the brain of said subject.

[0082] BTRFA elements (50), BTRFA-LED and / or BTRFA-LLL combinations as described above may also be used in methods of treating and / or preventing and / or alleviating brain injuries, such as concussions, traumatic brain injuries, and / or post stroke disorders, as well as in methods of treating, preventing and / or mitigating depression, migraine headaches, myodesopsia, and / or tinnitus in a subject in the need therefor, comprising one or more BTRFA elements (50) in proximity to, or in contact with, the subject’s head and permitting direct transcranial administration of one or more electromagnetic signals, alone or in combination with red and / or NIR light, to the brain of said subject.

[0083] BTRFA elements (50), BTRFA-LED and / or BTRFA-LLL combinations as described above may further be used by healthy patients for general wellness purposes, particularly in methods of relieving headaches and signs of fatigue, and / or enhancing general mental and cognitive abilities.

[0084] The whole head and brain, or specific regions of the head such as the frontal, parietal, occipital and / or temporal lobes, may thus be transcranially exposed to a pulsed electromagnetic field (RF) signal, alone or in combination with pulsed red and / or NIR signals as described above. As described above, BTRFA elements (50), BTRFA-LED and / or BTRFA-LLL combinations according to the present invention generate pulsed electromagnetic waves and red / NIR light that penetrate efficiently through the human skull into cortical brain tissue. In particular, simulations and dosimetric analyses indicate that approximately 80-90% of the emitted pulsed RF power and about 20% of the incident red / NIR light are absorbed in the head of the subject.BTRFA elements therefore provide a reliable, reproducible and efficient specific absorption rate (SAR) distribution within human brain tissue, enabling controlled non-thermal RF exposure. Consequently, BTRFA elements, BTRFA-LED and / or BTRFA-LLL combinations are particularly suitable for transcranial administration of one or more RF electromagnetic signals, alone or in combination with red and NIR light, toward the skull and brain of a subject and can advantageously be integrated into a medical wearable head device.

[0085] As explained above, BTRFA elements (50) according to the present invention may be provided in different shapes and sizes so as to conform to a wide range of human body tissues and, in the case of head exposure, to accommodate a wide range of skull geometries, thereby enhancing coverage of the whole brain or of selected brain lobes in a given subject. In addition, they can advantageously be formed with inwardly curved or bent profiles in both the longitudinal and transverse directions, allowing placement in close proximity to rounded portions of the body tissue - such as the skull when targeting frontal, parietal, temporal and / or occipital regions- and thereby further optimizing coverage of global and / or specific cortical brain areas.

[0086] Another important advantage of the body-tissue radiofrequency applicator elements (50) of the present invention is their significantly widened resonance bandwidth, which maintains good impedance matching even when the BTRFA elements are positioned at different distances from a human body tissue, such as for example a subject’s head.

[0087] According to a third aspect, the present invention provides a non-invasive neuromodulation medical or wellness wearable device comprising one or more BTRFA elements (50), alone or in combination with one or more low-level lasers (LLL) and / or light-emitting diodes (LEDs) (200) as described above. The wearable device may be used to directly administer one or more electromagnetic signals, alone or in combination with red and / or NIR light, to human body tissues or organs such as the head and brain, abdomen and gut, neck, back, and / or limbs. According to this aspect, the invention preferably provides a non-invasive neuromodulation wearable head device, and most preferably a non-invasive neuromodulation medical head-worn device.

[0088] One or more BTRFA elements (50) may be embedded within the wearable head device in positions proximal to the subject’s head when the device is worn, so that the electromagnetic signals are directed inward toward the head. The wearable head device comprises a single BTRFA element (50) delivering one or more electromagnetic signals as described above. Alternatively, the wearable head device comprises more than one BTRFA element (50) which are spaced apart so as to deliver one or more substantially homogeneous pulsed electromagnetic signals toward the head with little or no overlap between adjacent applicators. The subject’s head and cortex can thus receive directional and uniform exposure to the one ormore electromagnetic signals, enabling more focused treatment and reducing power losses due to radiation emitted into the surrounding air.

[0089] The wearable head device according to the present invention may comprise a head unit, such as a head cap, helmet or headset, configured to hold the one or more BTRFA elements (50) in predetermined positions in proximity to the subject’s head. The BTRFA elements (50) are supported within the head unit and interconnected by flexible elements so as to accommodate different head sizes and shapes, allowing each individual BTRFA element to be gently pressed against the relevant body part, in particular the head, hair and skull. Where more than one BTRFA element is provided, the elements may further comprise attachment means (3) that permit positional adjustment and mutual positioning of the BTRFA elements with respect to one another.

[0090] The non-invasive neuromodulation wearable device is configured such that the specific absorption rate (SAR) within the treated or targeted human tissue, for example the cerebral cortex, lies within about 0.2-10 W / kg, preferably within about 0.2-3 W / kg, 0.5-2.5 W / kg, or 1-2 W / kg, and most preferably around 0.4-0.9 W / kg.

[0091] The human subject wearing the non-invasive brain-stimulation head device may receive a substantially homogeneous exposure to one or more electromagnetic signals without experiencing any uncomfortable sensations of heat or pain. Under the operating conditions described herein, the one or more pulsed RF electromagnetic signals do not produce a measurable or clinically relevant increase in the temperature of the targeted body tissue. The non-invasive brain-stimulation head device comprises one or more BTRFA elements that can be activated sequentially or in combination to generate a radiation pattern suitable for treatment of the brain. Preferably, the BTRFA elements radiate in an on / off sequential order, such that when one BTRFA element is off another is on, and each element emits in turn in a sequential fashion. In this way, a single waveform generator can be shared by multiple applicators. The device may thus operate with a single active BTRFA element at any given time, or with one or more BTRFA elements that are driven in sequence or, where desired, simultaneously. By way of example, the wearable head device comprises more than one BTRFA element and may deliver pulsed electromagnetic signals in a sequential manner such that no two applicators are simultaneously delivering or discharging.

[0092] The BTRFA elements may be configured to emit at different frequencies. A single BTRFA element may alternately emit high and low frequencies in a sequential manner. Alternatively, a first BTRFA element may radiate at a higher frequency while a second BTRFA element radiates at a lower frequency, with the radiating characteristics being switchable such that the first BTRFA element subsequently operates at the lower frequency and the second BTRFA element operates at the higher frequency. A given frequency may be distributed to multipleBTRFA elements simultaneously, or multiple frequencies may be generated and delivered to the body-tissue radiofrequency applicators. For example, the head device may comprise one or more BTRFA elements (50) operating at three different RF frequencies selected to provide sufficient penetration depth and coverage at each of the predetermined target locations. Advantageously, the one or more BTRFA elements (50) described above may be used alone or in combination, within the wellness or medical head device of the present invention, together with one or more low-level lasers (LLL) and / or light-emitting diodes (LEDs) (200) configured to emit red and / or near-infrared light. This configuration permits administration of one or more pulsed electromagnetic signals either alone or in synergistic combination with one or more pulsed red and near-infrared (NIR) light signals to the body tissue of a subject in need thereof. The combinations of the one or more BTRFA elements (50) and the array of one or more low-level lasers (LLL) and / or light-emitting diodes (LEDs) (200) may be embedded within, or mechanically attached to, the head device, which is configured to fit on the head of a human subject such that the combined BTRFA elements and LLLs and / or LEDs are positioned adjacent to the head when the device is worn. BTRFA-LED or BTRFA-LLL combinations may, for example, be enclosed in hollow housings interconnected by flexible or elastic connection means and integrated within the head device together with the associated electronic circuitry (including one or more motherboards) required fortheir operation.

[0093] When positioned over the head of a subject, the head device allows the one or more BTRFA elements (50), used alone or in combination with the LLLs and / or LEDs (200), to deliver to the whole head and brain - or selectively to specific regions such as the frontal, parietal, occipital and / or temporal lobes - a therapeutically effective amount of electromagnetic energy, optionally together with a therapeutically effective amount of red and NIR light. The head device may comprise one or more BTRFA elements (50) and a total number of LLLs and / or LEDs (200) ranging, for example, from about 10 to about 300, or from 20 to 200. In one embodiment, illustrated in Figures 8 and 11 A, the head device includes four BTRFA elements (50), each carrying 24 LEDs (200).

[0094] Within the wellness or medical head device, the BTRFA elements (50) and the LLLs and / or LEDs (200) are spatially arranged to provide a preferably homogeneous application of pulsed electromagnetic energy and red / NIR light to the head, while minimizing or avoiding unnecessary overlap of the respective signals. In particular, the LLLs and / or LEDs are disposed in the central region of the RF traces (7), thereby helping to maintain a controlled spatial relationship between the RF and optical emission zones.The electronic control system comprises circuitry for generating the electromagnetic signals and associated amplification stages. In one embodiment, the control system includes (a) a single transmitter configured to sequentially drive different antenna sets, (b) a switching device that, for each activation period within an activation sequence, selects which of the one or more BTRFA elements is to be driven, and (c) a controller. The controller determines, for each activation sequence, the power output of each BTRFA element and generates an adjusted control signal for the single transmitter such that the power output of at least one BTRFA element is maintained at a desired average value, irrespective of the load presented by that BTRFA element.

[0095] The wearable head device may further comprise a control box for ON / OFF switching by the patient or caregiver, a battery, and optionally a timer and / or means for shielding out-radiation and / or feedback circuitry. For practical and convenient use, the means for generating and amplifying the electromagnetic waves, as well as the red and NIR light signals, are preferably compact, allowing the patient to wear the device and move freely at home, for example while reading, watching TV, sleeping or cooking.

[0096] The control box for activating the one or more BTRFA elements, optionally with LLLs and / or LEDs, may be integrated into the head device or provided as a separate module connected via a cable. Preferably, the wellness or medical head device comprises a head unit carrying the BTRFA elements, optionally with LLLs and / or LEDs, which are connected to a controller or control box that can be worn on the arm or conveniently placed nearby, for example on a table or chair back. The power supply may be any suitable battery, such as a rechargeable battery, or an energy-harvesting system integrated into the head device. The timer may, for example, be a stop-timer that automatically switches the device off at the end of a session, and the device may further include a status indicator, such as an audio, visual, or tactile signal, to indicate completion of the session.

[0097] Means for shielding out-radiation may be provided to reduce or eliminate electromagnetic waves radiating away from the human subject’s head or body part when the device is in place; such means may include one or more shielding elements. Feedback circuitry may be used to adjust treatment parameters dynamically; for instance, if a particular patient exhibits a more favorable response to a given frequency within the therapy regimen, the treatment protocol may be adapted to emphasize that frequency.

[0098] The non-invasive neuromodulation head device described herein may be configured either as a wellness head device for non-medical use or as a medical head device for therapeutic use, and may take the form of smart hat or augmented headgear as illustrated, for example, in Figures 10 and 11. The smart wearable headgear may comprise a cap with a semi-rigidstructure that conforms to the user’s head, optionally incorporating an internal grid structure that supports multiple electronic components for monitoring, stimulating, or processing neurological signals, and is particularly useful for cognitive-enhancement applications.

[0099] In addition to the BTRFA elements (50), LLLs and / or LEDs (200), the smart hat device may include multiple sensors, such as neurological sensors, processing units, and wireless communication modules, with the cap designed to fit comfortably while maintaining precise sensor positioning. Neurological sensors may include, for example, electrodes for detecting brain activity (such as electroencephalogram (EEG) electrodes), near-infrared spectroscopy (fNIRS) sensors, or magnetometers. The processing units may comprise embedded microcontrollers or Al-enabled chips for data analysis, including machine-learning algorithms that analyze brainwave patterns and provide real-time feedback. Wireless communication modules, such as Bluetooth, Wi-Fi or 5G, enable real-time data transmission to external devices for monitoring and analysis.

[0100] According to a fourth aspect of the invention, the one or more BTRFA elements and the non-invasive neuromodulation wearable head device described herein are used in a method for treating and / or preventing neurodegenerative proteinopathies and / or diseases, and for stabilizing and / or reversing symptoms of such diseases. These include, for example, Alzheimer’s disease (AD), subjective cognitive decline (SCD), mild cognitive impairment (MCI), amnestic mild cognitive impairment (aMCI), Parkinson’s disease, cerebral amyloid angiopathy, dementia with Lewy bodies (DLB), frontotemporal dementia (including variants such as semantic dementia, primary progressive aphasia, and Pick’s disease) in a human subject in need thereof, comprising administering one or more pulsed electromagnetic signals generated by the BTRFA elements, either alone or in combination with red and / or near-infrared signals generated by one or more LLLs and / or LEDs. Treatment and / or prevention in this context encompasses alleviation and / or modification of underlying brain pathology as well as improvement in clinical and behavioral symptoms.

[0101] In this aspect, the method comprises positioning one or more BTRFA elements, or the wearable medical head device, in close proximity to the subject’s head; activating the one or more BTRFA elements alone or in combination and, where desired, simultaneously with one or more LLLs and / or LEDs emitting red and / or NIR light; and transcranially exposing the subject’s head and cortex to a therapeutically effective dose of pulsed electromagnetic waves at one or more frequencies and with a defined specific absorption rate (SAR), and optionally to a therapeutically effective dose of red and NIR light at one or more predetermined wavelengths as described above.By activating the one or more BTRFA elements alone, or in combination and simultaneously with the array of red and NIR light sources, the subject’s head and cortex can be transcranially exposed, for a predetermined treatment period, to a therapeutically effective dose of pulsed electromagnetic energy or field at one or more specific frequencies and SAR values, together with red and NIR light as defined above.

[0102] Dementia is a clinical syndrome that was first described in the early 19th century, when it was considered a form of “mental alienation” alongside conditions such as schizophrenia and severe mood disorders. Today, multiple dementia subtypes are recognized, but they share a common defining feature: a progressive decline in memory and other cognitive abilities severe enough to interfere with daily activities and persisting for at least several months. These cognitive and social impairments arise not from primary psychiatric illness but from well-characterized organic changes, namely the progressive degeneration and loss of neurons in specific brain regions, placing the various dementias within the broader category of neurodegenerative diseases.

[0103] Among neurodegenerative dementias, Alzheimer-type dementia (Alzheimer’s disease, AD) is the most common. First described by Alois Alzheimer in 1906, AD is a chronic, progressive neurodegenerative disorder whose prevalence is rising rapidly as life expectancy increases, making effective treatment an urgent public-health priority. WHO estimates that AD is the leading cause of dementia, accounting for roughly 60-70% of cases and contributing to a global dementia population of about 55 million people.

[0104] The neuropathological hallmarks of AD are extracellular amyloid-beta (A|3) plaques and intracellular neurofibrillary tangles composed of hyperphosphorylated tau protein. The principal Ap species, AP1-40 and AP1-42 peptides, are generated from amyloid precursor protein by sequential proteolytic cleavage involving beta- and gamma-secretases, with A|342 showing greater aggregation propensity and a key role in plaque nucleation. In parallel, A|3 accumulation initiates a cascade that promotes abnormal phosphorylation and aggregation of tau, a microtubule-associated protein, leading to the formation of intraneuronal neurofibrillary tangles. Converging evidence indicates that soluble oligomeric forms of A|3 and tau act synergistically to disrupt synaptic function, ultimately driving loss of synaptic connections, neuronal death - particularly of pyramidal neurons in temporal and related cortices - and widespread network failure.

[0105] In early AD, A|3 plaques and tau aggregates appear most prominently in the hippocampus, entorhinal cortex, and posterior cingulate cortex, regions that are critical for memory formation and spatial orientation. As pathology spreads, it involves increasingly large portions of the cerebral cortex, leading to progressive disconnection of neuronal networks, cortical atrophy, and characteristic clinical manifestations. Patients develop worsening memory loss, confusion,mood and personality changes, and increasing difficulty performing basic activities of daily living.

[0106] International diagnostic standards for AD rely on clinical history, neuropsychological testing, physical and neurological examination, and supportive laboratory and biomarker assessments. The widely used NINCDS-ADRDA and NIA-AA criteria define possible, probable, and definite AD based on the pattern of cognitive impairment, progression, exclusion of alternative causes, and, in research settings, confirmation by biomarkers or histopathology. WHO and major clinical guidelines typically describe three broad clinical stages - mild, moderate, and severe -along a continuum of progressive cognitive and functional decline. Clinically, this course is often further detailed into seven stages, from preclinical or very mild impairment through moderate stages with marked memory and language difficulties, to advanced stages characterized by profound dependence, loss of recognition, and additional neurological complications such as motor deficits and severe behavioral disturbances.

[0107] The BTRFA-based non-invasive neuromodulation head devices and methods of the present invention are particularly suited for preventing, stabilizing, and / or reversing symptoms of AD across its clinical spectrum - mild, moderate, and severe - within the framework of established diagnostic criteria such as NINCDS-ADRDA. In certain embodiments, treatment regimens involve applying the medical head device to the subject’s head for one or more daily sessions, for example a single session or multiple spaced-apart sessions per day. A representative protocol may comprise positioning the device for about 15-60 minutes, preferably about 30-60 minutes, once or twice daily, or every other day depending on the severity of the disease, so that therapeutically effective doses of pulsed electromagnetic signals generated by one or more body-tissue radiofrequency applicators (50) and pulsed red and / or near-infrared light generated by one or more LLLs and / or LEDs (200) are simultaneously delivered to the subject’s head.

[0108] The combined application of these signals can provide deeper penetration through the meninges, cranial bone, and into the brain parenchyma than either modality alone. In addition, their simultaneous use is expected to exert synergistic molecular and cellular effects, including enhanced mitochondrial activity with increased adenosine triphosphate (ATP) production and improved metabolic capacity, thereby counteracting the reduced ATP levels observed in many neurological disorders. The combined stimulation may also augment anti-inflammatory actions, for example via down-regulation of cyclo-oxygenase-2 (COX-2), NF-KB and tumor necrosis factor-a (TNFa), along with reduced oxidative stress and decreased production of reactive oxygen species (ROS).Furthermore, a beneficial modulation of pro- and anti-inflammatory cytokine profiles within the brain parenchyma is anticipated, with a shift of macrophages and microglia from a pro-inflammatory M1-like phenotype toward an anti-inflammatory M2-like phenotype that promotes phagocytosis and clearance of amyloid plaques and beta-amyloid aggregates. Additional synergistic effects may include increased hemoglobin oxygenation and vasodilation, leading to improved cerebral blood flow, tissue oxygenation, and delivery of nutrients to the brain parenchyma.

[0109] A battery of standardized neuropsychological tests can be used to identify symptoms and to monitor treatment effects on the progression of Alzheimer’s disease, including the ADAS-Cog-Plus or ADAS-Cog14 (Alzheimer’s Disease Assessment Scale - Cognitive Subscale 14), the Mini-Mental State Examination (MMSE), Logical Memory Tests I and II, Trail Making Tests A and B, the Boston Naming Test, and Auditory Verbal Learning Tests, administered before and after at least two months of treatment.

[0110] Alzheimer’s subjects at mild, moderate, or even severe stages who use the non-invasive medical head device of the present invention for 30 to 60 min daily twice daily or every other day depending on the severity of the disease, over at least two consecutive months, with a minimum interval of about 7 hours between daily sessions, are expected to exhibit beneficial cognitive and executive changes, better quality of life with improved sleep, reduced anxiety, agitation and apathy, improved mood and energy, and a reduced burden on caregivers. Cognitive improvement and potential reversal of decline may be evidenced by changes in neuropsychological test performance, for example on ADAS-Cog14, MMSE, or the Rey Auditory Verbal Learning Test (Rey AVLT), or on any of the tests described in the Examples below.

[0111] In addition, synergistic biological effects are anticipated in terms of enhanced degradation and clearance of beta-amyloid plaques and A|3 oligomers in plasma and cerebrospinal fluid. More specifically, treatment is expected to promote destabilization of insoluble amyloid-p plaques and / or neurofibrillary tangles in the brains of AD patients; dissociation of insoluble amyloid-p deposits in senile plaques into soluble A|3 oligomers / monomers and / or disassembly of neurofibrillary tangles; and subsequent elimination or clearance of soluble A|3 oligomers / monomers and tau species via CSF and plasma pathways.

[0112] Alzheimer’s disease subjects are expected to show changes from baseline in core biomarkers of Alzheimer’s pathology -such as beta-amyloid peptides 1-40 and 1-42, total tau (t-tau), and phosphorylated tau (p-tau) - in blood and cerebrospinal fluid (CSF) before and after completing a 2-month treatment with the device described above. In particular, increased levels of soluble monomeric AP1-40 and AP1-42 and of oligomeric A|3 aggregates in plasma and CSF are anticipated following such a 2-month treatment regimen with the medical head device of thepresent invention. Plasma and CSF concentrations of A|31-40, A|31-42, t-tau, and p-tau can be quantified using standard immunoassay techniques, for example ELISA-based methods. In addition, patients with early, mild, or moderate Alzheimer’s disease - or their caregivers -may observe meaningful clinical benefits, including improved sleep quality, reduced anxiety and agitation, diminished apathy, and better mood and energy.

[0113] Mild Cognitive Impairment (MCI) is defined as a level of cognitive decline greaterthan expected for age and education, but not severe enough to cause major interference with independence in everyday activities. MCI can affect memory, attention, language, and executive function, and is considered an intermediate state between normal aging and dementia. Its causes are heterogeneous and include vascular factors (for example, small vessel disease, stroke, and other cardiovascular conditions), early-stage neurodegenerative diseases (such as Alzheimer’s disease, Parkinson’s disease, or related disorders), metabolic or systemic conditions, and certain psychiatric conditions including depression and anxiety. Diagnosis and follow-up typically rely on brief cognitive screening tools such as the Montreal Cognitive Assessment (MoCA), the Mini-Mental State Examination (MMSE), and drawing or visuospatial tasks such as the Clock Drawing Test, combined with biomarker assessments tailored to the suspected etiology, for example structural MRI for atrophy patterns, PET imaging for metabolism or amyloid burden, and cerebrospinal fluid (CSF) assays of proteins such as amyloid-beta and tau.

[0114] Amnestic Mild Cognitive Impairment (aMCI) is a subtype of MCI in which memory impairment is the predominant or isolated deficit, and it is most closely linked to early-stage Alzheimer’s disease. In aMCI, the earliest pathological changes - amyloid plaque deposition and tau-related neurofibrillary tangles - typically begin in the hippocampus and entorhinal cortex, regions critical for episodic memory. Clinically, aMCI is characterized by difficulty recalling recent events, names, or appointments, while other cognitive domains are relatively preserved and activities of daily living remain largely intact. The widely used Petersen criteria require: a subjective memory complaint (ideally corroborated by an informant), objective evidence of memory impairment on testing, essentially preserved overall cognitive function, intact everyday activities, and absence of dementia. Monitoring aMCI often involves memory-focused neuropsychological tests such as the Rey Auditory Verbal Learning Test (RAVLT) and the California Verbal Learning Test (CVLT), which probe delayed recall and recognition, together with Alzheimer’ s-type biomarkers, including reduced CSF amyloid-beta 42, elevated total and phosphorylated tau, and amyloid-sensitive PET imaging demonstrating cortical amyloid plaque deposition.Parkinson’s disease (PD) is the second most common neurodegenerative disorder after Alzheimer’s disease and primarily affects motor control. It is characterized by progressive loss of dopamine-producing neurons in the substantia nigra pars compacta, leading to dopamine depletion in the striatum and disruption of basal ganglia circuits that regulate movement. Intracellular inclusions composed mainly of misfolded alpha-synuclein (Lewy bodies and Lewy neurites) are a pathological hallmark and are closely associated with neuronal dysfunction and death. Oxidative stress, mitochondrial dysfunction, genetic susceptibility, and environmental exposures all contribute to PD pathogenesis.

[0115] Clinically, PD manifests with both motor and non-motor symptoms. Core motor features include resting tremor, bradykinesia (slowness and difficulty initiating movement), muscular rigidity, and postural instability, often accompanied by gait disturbance and falls. Non-motor symptoms are also prominent and may include cognitive impairment, depression, anxiety, apathy, sleep disturbances, autonomic dysfunction (such as constipation and orthostatic hypotension), and sensory complaints like loss of smell. The disease typically progresses from mild, unilateral symptoms to severe disability. Commonly described stages range from: Stage 1 (unilateral signs, minimal functional impact), Stage 2 (bilateral involvement without balance impairment), Stage 3 (postural instability with increased falls, but preserved independence), Stage 4 (severe disability requiring assistance with daily activities, though standing and walking may still be possible), to Stage 5 (wheelchair-bound or bedridden, requiring full-time care).

[0116] Diagnosis of PD is primarily clinical. Consensus criteria, such as those of the Movement Disorder Society (MDS) and the UK Parkinson’s Disease Society Brain Bank, typically require bradykinesia plus at least one of resting tremor, rigidity, or postural instability, along with supportive features such as clear benefit from dopaminergic therapy and absence of red-flag signs pointing to atypical parkinsonism. Work-up includes a detailed medical history and neurological examination. Ancillary tests can support the diagnosis in uncertain cases: dopamine transporter imaging (e.g., DaTscan SPECT) helps demonstrate presynaptic dopaminergic deficit, MRI can exclude structural mimics, and research biomarkers such as altered cerebrospinal fluid alpha-synuclein levels are under investigation as potential diagnostic and progression markers.

[0117] The electromagnetic waves, delivered alone or in combination with red and near-infrared (NIR) light, are configured to reduce or eliminate tremor (including resting tremor), bradykinesia, cognitive impairment, and mood symptoms in subjects with Parkinson’s disease. Without being bound by theory, it is believed that such radiation upregulates endogenous neuroactive compounds in the brain, including neurotrophic factors, thereby promoting neural growth,neurogenesis, and / or synaptic plasticity and contributing to a more physiological balance of neurotransmitter systems that underlies these beneficial effects.

[0118] The medical head device may be used either as a standalone therapy or as an adjunct to standard Parkinson’s disease pharmacotherapy, including dopaminergic regimens such as carbidopa-levodopa, with the combined approach expected to enhance symptomatic relief and possibly improve responsiveness to medication.

[0119] Lewy body dementia (LBD) is a progressive neurodegenerative dementia characterized by intracellular aggregates of alpha-synuclein (Lewy bodies) within neurons. These inclusions occur in multiple brain regions, including the cerebral cortex, limbic structures, and brainstem nuclei, and disrupt neuronal function in networks subserving cognition, movement, and behavior. LBD is associated with dysfunction of several neurotransmitter systems, most notably dopaminergic and cholinergic pathways: degeneration of dopamine-producing neurons contributes to parkinsonian motor features, while cholinergic deficits underlie prominent cognitive and attentional disturbances. LBD frequently coexists with Alzheimer-type pathology, including amyloid plaques and neurofibrillary tangles, which complicates diagnosis and contributes to clinical heterogeneity. Clinically, LBD encompasses two closely related entities: dementia with Lewy bodies (DLB) and Parkinson’s disease dementia (PDD). DLB is diagnosed when cognitive impairment and parkinsonism arise within about one year of each other, or when dementia precedes motor symptoms, whereas PDD is diagnosed when established Parkinson’s disease is followed by dementia after more than a year. Core clinical features include fluctuating attention and alertness, recurrent well-formed visual hallucinations, parkinsonian motor signs such as bradykinesia, rigidity and resting tremor, and varying degrees of memory impairment (often less prominent early than in Alzheimer’s disease). Mood and anxiety disorders are common and may worsen cognitive symptoms, with overall severity progressing from mild through moderate to advanced stages. Cognitive assessment typically employs instruments such as the Mini-Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA), while tests like the Trail Making Test or Stroop Test are useful for detecting the attentional and executive dysfunction characteristic of LBD. Ancillary investigations may include cerebrospinal fluid analysis of alpha-synuclein, amyloid-beta, and tau species, which can help distinguish LBD from pure Alzheimer’s disease in appropriate clinical contexts.

[0120] Frontotemporal dementia (FTD) comprises a group of neurodegenerative syndromes that predominantly affect the frontal and temporal lobes, leading to progressive changes in behavior, personality, language, and, in some variants, motor function. It is a leading cause of young-onset dementia (typically under 65 years), though it also occurs in older adults. Clinical presentations are commonly categorized into behavioral-variant FTD, with early disinhibition,apathy, loss of empathy, compulsive behaviors, and executive dysfunction, and language variants grouped under primary progressive aphasia (PPA). Within the language spectrum, semantic dementia (SD) is characterized by profound loss of word meaning and object knowledge despite fluent speech, while other PPA variants show non-fluent / agrammatic or logopenic language profiles. Pick’s disease is a historical and pathological subtype of FTD defined by the presence of Pick bodies -spherical intraneuronal inclusions composed of abnormal tau protein - predominantly in frontal and temporal cortical regions. These tau aggregates, found in ballooned “Pick cells,” are distinct from the neurofibrillary tangles observed in Alzheimer’s disease. The underlying pathology involves selective neuronal loss and gliosis in affected areas, resulting in progressive focal atrophy of frontal and / or temporal lobes and the corresponding behavioral, language, and cognitive deficits. Clinically, Pick’s disease often overlaps symptomatically with other FTD forms, manifesting as prominent personality change, social inappropriateness, language impairment, and eventual global cognitive decline.

[0121] A substantial proportion of frontotemporal dementia (FTD) cases - approximately 30-50% -have a familial basis and are associated with pathogenic variants in genes such as MAPT (microtubule-associated protein tau), GRN (progranulin), and C9orf72 (chromosome 9 open reading frame 72). In FTD, selective degeneration of frontal and temporal neurons leads to focal atrophy in these regions, driven predominantly by tau pathology (abnormal tau aggregation) and / or TDP-43 pathology (accumulation of TAR DNA-binding protein 43), both of which contribute to neuronal dysfunction and death. Semantic dementia (SD) is marked by progressive degeneration of the anterior temporal lobes, typically left-sided, which are critical for semantic memory, and is frequently associated with TDP-43 proteinopathy. Clinically, SD presents as a progressive loss of word and object meaning and impaired comprehension and naming, and diagnosis is grounded in consensus FTLD criteria emphasizing progressive semantic loss together with characteristic left temporal atrophy on neuroimaging.

[0122] Primary progressive aphasia (PPA) is a language-predominant neurodegenerative syndrome caused by focal degeneration of frontal and temporal language networks. Underlying pathology may involve tauopathies, TDP-43 proteinopathies, or, in a subset of cases, Alzheimer-type pathology. PPA is characterized by an insidious, gradually progressive language impairment with relative sparing of other cognitive domains in the early course and is classified into three main variants: non-fluent / agrammatic, semantic (overlapping with SD), and logopenic. In contrast to typical amnestic dementias, language dysfunction - rather than memory or behavior - is the initial and principal deficit.FTD symptomatology typically includes early executive dysfunction (impaired planning, judgment, and problem-solving) with comparatively preserved episodic memory, together with prominent behavioral changes such as disinhibition, apathy, loss of empathy, stereotyped or compulsive behaviors, and altered eating patterns. In SD and PPA, there is a progressive decline in language abilities: patients gradually lose knowledge of word meanings, develop anomia (difficulty naming objects), and experience increasing difficulty understanding spoken and written words. Disease evolution can be conceptualized in three stages: an early stage with mild cognitive, behavioral, and language changes; a moderate stage with more pronounced behavioral disturbance, marked impact on daily functioning, and substantial loss of vocabulary and comprehension; and a late stage characterized by severe global cognitive impairment, near-total loss of communicative ability in language variants, and complete dependence on caregivers.

[0123] Multiple investigations support diagnosis and longitudinal monitoring. Cerebrospinal fluid biomarkers, including measures of tau species, TDP-43-related signatures (where available), and Api-42, can assist in differentiating FTD from Alzheimer’s disease in appropriate contexts. Structural MRI or CT typically reveals focal atrophy of frontal and / or temporal lobes, while FDG-PET demonstrates hypometabolism in corresponding regions; amyloid PET may help identify concomitant Alzheimer pathology, particularly in logopenic PPA. Neuropsychological assessment focuses on executive function, social cognition, and behavior for FTD syndromes, and detailed language batteries for SD / PPA. Speech and language evaluations commonly employ tools such as the Western Aphasia Battery (WAB), the Boston Naming Test, and semantic association tasks such as the Pyramids and Palm Trees Test to quantify naming, comprehension, and semantic memory deficits.

[0124] Cerebral amyloid angiopathy (CAA) is a cerebrovascular disorder in which amyloid-beta deposits accumulate in the walls of small and medium-sized cerebral blood vessels, making them fragile and prone to bleeding (microbleeds and larger lobar hemorrhages). This vascular damage can lead overtime to cognitive decline and, in some individuals, vascular dementia. Clinically, CAA may present with recurrent lobar intracerebral hemorrhages, transient focal neurological episodes, seizures, or more insidious symptoms such as headaches, progressive memory problems, and other cognitive impairments. In more severe or advanced cases, repeated bleeding and associated brain injury can result in significant cognitive deterioration and dementia.

[0125] The BTRFA elements or medical wearable head device described above may be used in methods of treating, preventing, and / or alleviating traumatic brain injury (TBI), concussions (mild TBI), and other neurological conditions such as brain tissue ischemia due to stroke, post-stroke sequelae, head or cerebral injury, and related neurological damage in a subject inneed thereof. In such methods, one or more pulsed electromagnetic signals generated by one or more BTRFA elements alone or in combination with red and / or near-infrared signals generated by one or more LEDs and / or LLLs is administered to the subject. The invention thus provides a method of treating, preventing, or alleviating brain injuries - including concussions, TBI, and post-stroke disorders - by positioning the one or more BTRFA elements or medical head device in close proximity to the subject’s head, activating the one or more BTRFA elements either alone or in combination and simultaneously with an array of red and NIR light sources, and transcranially exposing the head and cortex to a therapeutically effective dose of pulsed electromagnetic energy at one or more specified frequencies and SAR values, together with red and NIR light at selected wavelengths as described above.

[0126] Traumatic brain injury remains a leading cause of morbidity and mortality worldwide, in both civilian and military populations, and constitutes a major global health and socioeconomic challenge. The World Health Organization has highlighted road traffic crashes as a major contributor to TBI and disability, with tens of millions of non-fatal injuries each year. Although earlier projections anticipated that road traffic injuries would rank among the top causes of global disease burden, recent global burden estimates indicate that, despite some decline, road injuries remain a major cause of death and disability and disproportionately affect older adults and vulnerable road users.

[0127] Tissue damage in head injuries such as TBI arises from both primary mechanical insult and secondary pathophysiological cascades. Primary injury involves direct mechanical disruption of brain tissue, including neuronal and vascular damage that can result in cell membrane rupture, vascular injury, and immediate ischemic cell death. Secondary processes - such as cerebral edema, blood-brain barrier disruption, excitotoxicity, mitochondrial dysfunction, and a robust neuroinflammatory response - can extend damage to initially uninjured tissue. Activated astrocytes and microglia release pro-inflammatory cytokines (for example IL-1 p, TNF-a, and IL-6), along with excitatory amino acids and reactive oxygen and nitrogen species, which together exacerbate neuronal injury. Even in diffuse injuries without obvious focal lesions, these secondary cascades can produce significant and potentially preventable tissue damage. While primary mechanical damage is irreversible, secondary swelling and inflammation represent key targets for therapeutic intervention.

[0128] Concussions represent milder forms of TBI resulting from rapid acceleration - deceleration of the brain within the skull, typically due to blows or jolts to the head or body. They often cause transient loss of consciousness or confusion, headaches, dizziness, and other short-term neurological symptoms. More broadly, head injury refers to trauma involving the scalp, skull, or brain, while cerebral injury denotes direct damage to brain parenchyma from mechanismssuch as trauma, ischemic or hemorrhagic stroke, or hypoxic events - each capable of inducing substantial local tissue injury and neuroinflammation.

[0129] One or more BTRFA elements, or the medical wearable head device of the present invention, may be positioned in proximity to - and, where appropriate, in direct contact with - the injured region of the head, or in direct contact with the scalp and / or skull. In this configuration, the device can deliver a substantially homogeneous and reproducible exposure of the injured area, or of the entire cortex, to electromagnetic waves alone or in combination with red and near-infrared light. The combined electromagnetic and optical neuromodulation is expected to promote neuroregeneration, attenuate inflammation, improve cerebral blood flow, modulate neuronal activity, stimulate cellular repair processes, reduce oxidative stress, and enhance synaptic plasticity. In particular, increased production of adenosine triphosphate (ATP) and upregulation of neurotrophic factors such as nerve growth factor (NGF) and brain-derived neurotrophic factor (BDNF) are anticipated to support neuroprotection, neuroregeneration, and repair of damaged neural tissue, thereby improving overall brain function.

[0130] The medical wearable head device and / or individual BTRFA elements placed near a target region may exert anti-inflammatory effects that are especially valuable in neurological injury, by modulating pro-inflammatory cytokine activity and reducing infiltration and activation of inflammatory cells within affected areas. This modulation can help limit the extent of secondary brain damage following TBI, stroke, concussion, or related insults, leading to better outcomes and faster recovery. In addition, treatment is expected to enhance microcirculation and cerebral blood flow by promoting vasodilation and improving rheology, thereby increasing oxygen and nutrient delivery to compromised brain tissue. Where cerebral perfusion is impaired, pulsed electromagnetic field signals can contribute to restoring circulation and oxygenation, reducing further ischemic injury and supporting functional recovery.

[0131] Patients may undergo this non-invasive treatment on a daily basis over extended periods, for example for several consecutive months, using a regimen comprising about 5 to 30 minutes, or about 10 to 20 minutes, of stimulation per day.

[0132] The BTRFA elements or the medical wearable head device of the present invention may be used in methods of treating, preventing, and / or reducing symptoms of depression, as well as for mitigating migraines, myodesopsia and vitreous opacities, and tinnitus in a human subject in need thereof. These methods comprise administering one or more pulsed electromagnetic signals generated by one or more BTRFA elements alone or in combination with red and / or near-infrared (NIR) light generated by one or more LEDs and / or LLLs, by positioning one or more BTRFA elements or the medical head device close to the subject’s head and transcranially exposing the cortex to a therapeutically effective dose at defined frequencies, SAR values, and optical wavelengths as specified above.Depression is a highly prevalent disorder, with an estimated 20-25% of individuals experiencing at least one depressive episode during their lifetime, affecting children, adults, and older people. Major depression and chronic (persistent) depression share a symptom profile that includes low mood, loss of energy, hopelessness, impaired concentration, sleep disturbance, and irritability, but differ in severity and duration. Untreated depression is associated with increased risk of substance abuse, self-harm, and suicide. In one embodiment, one or more BTRFA elements or the medical head device are placed in direct contact with the scalp and / or skull to provide a homogeneous and reproducible exposure of the cortex to electromagnetic waves alone or in combination with red and NIR light. Patients with depressive episodes may wear the device daily for several consecutive months, for example for about 5-30 minutes, or around 10-20 minutes, per day or every other day. Under these conditions, the electromagnetic and optical stimulation is sufficient to reduce or eliminate depressive symptoms and / or delay, attenuate, or prevent the onset of new episodes. Without being bound by theory, these effects are believed to result from upregulation of endogenous neuroactive factors — including neurotrophic molecules such as BDNF- that promote neural growth, neurogenesis, and synaptic plasticity, and / or from a shift toward a more physiological balance of neurotransmitter systems in the brain. The medical head device may be used as monotherapy or as an adjunct to standard antidepressants, including tricyclic antidepressants (TCAs), monoamine oxidase inhibitors (MAOIs), selective serotonin reuptake inhibitors (SSRIs), and serotonin-norepinephrine reuptake inhibitors (SNRIs).

[0133] Migraines are common and often disabling, with attacks that may last 2-3 days and significantly impair quality of life and productivity. A typical migraine episode can involve a premonitory (“pre-headache”) phase, an aura phase with visual and / or sensory phenomena, a headache phase, and a postdrome phase characterized by fatigue and cognitive slowing. Some individuals experience chronic migraine, defined by headache on at least 15 days per month. In certain embodiments, patients with migraines or severe headaches may don the medical head device at the onset of early symptoms (for example, in the premonitory phase) or during an attack, for 5-30 minutes depending on pain intensity and may repeat treatment after an interval of about 7-8 hours as needed. The device may be used alone or in combination with established pharmacological therapies.

[0134] Tinnitus is the perception of continuous or intermittent sound in the absence of an external acoustic source and is frequently associated with sleep disturbance, emotional distress, anxiety, and depressive symptoms. It has diverse etiologies, including age-related cochlear degeneration, noise or drug-induced hair-cell damage, metabolic and psychological factors, and central nervous system disorders. The multimodal neuromodulatory approach of the present invention, combining pulsed electromagnetic fields with red / NIR light appliedtranscranially, is designed to modulate aberrant neural activity in auditory and associated networks and thereby reduce the severity or impact of tinnitus symptoms.

[0135] The BTRFA elements or the non-invasive medical head device of the present invention are further useful in a method of treating and / or preventing or managing tinnitus of fatigue-related origin and may be positioned close to, or so as to cover, tissues overlying the auditory apparatus for about 5-30 minutes once or twice daily, or every other day, to synergistically stabilize and / or relieve tinnitus symptoms and associated hearing complaints.

[0136] With aging and ocular fatigue, many individuals develop myodesopsia (vitreous floaters), caused by collagen-based condensations and opacities within the vitreous that scatter light and cast moving shadows on the retina, perceived as grey spots or threads of varying size and shape. Although historically regarded as benign, symptomatic vitreous floaters can significantly impair quality of life, in part through degradation of contrast sensitivity despite relatively preserved visual acuity. In certain embodiments, BTRFA elements or the medical head device are applied near the frontal or frontotemporal regions - or over the whole head - for about 5 to 30 minutes once or twice daily (with at least a 7-hour interval), or every other day, to help stabilize and / or alleviate symptoms of myodesopsia and eye fatigue.

[0137] The BTRFA elements and non-invasive head device may also be used in healthy subjects for general wellness, in particular for relieving headaches and fatigue and for enhancing brain activity and cognitive performance. In this context, the method comprises positioning the BTRFA elements or head device close to the head, activating one or more BTRFA elements in combination and simultaneously with an array of red and NIR LEDs, and transcranially exposing the head and cortex to an effective dose of pulsed electromagnetic energy at selected frequencies and SAR values together with red and NIR light at defined wavelengths. The approach leverages brain plasticity - the intrinsic capacity of neural circuits to adapt structurally and functionally - as a basis for supporting overall brain health.

[0138] Regular use of the non-invasive head device may help maintain general well-being by improving cerebral blood flow, modulating inflammation, and supporting cellular energy metabolism. In particular, improved microcirculation and vasodilation are expected to enhance oxygen and nutrient delivery, which may reduce the intensity and frequency of headaches. By boosting mitochondrial ATP production and optimizing microvascular perfusion, the device may also reduce subjective fatigue and low energy states. Furthermore, by promoting neurogenesis and synaptic plasticity, improving cerebral hemodynamics, and mitigating oxidative stress, regular sessions may enhance cognitive performance, including focus, concentration, memory, and mental clarity, while also helping to reduce anxiety.In preferred wellness embodiments, the device is configured as a wearable hat or augmented headgear (for example, as illustrated in Figures 11 and 12), which can be worn several times per week or daily for about 10-20 minutes, without causing pain or heat and without interfering with normal daily activities. Consistent use under these conditions can support a more energized, focused, and balanced mental and physical state, offering an attractive option for individuals seeking to improve overall quality of life.EXAMPLES

[0139] Example 1 : Pilot clinical phase for testing safety and efficacy of the medical head device on Alzheimer's disease

[0140] Example 1.1: Enrollment of patients

[0141] Device is intended for adults of 65 years and older, who have been diagnosed with mild or moderate stage of Alzheimer's Disease, according to the National Institute of Neurological and Communicative Disordersand Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria, and who are scoring between 16-26 at the Mini-Mental State Examination (MMSE).

[0142] In addition, blood brain biomarkers (BBM), such as A|342, A|340, and tau are used as prescreening tool to increase the prevalence of brain A|3 and tau pathology before confirming the AD diagnostic. These BBM will be also used as main inclusion criterion to select patients for which BBM can achieve sufficiently high diagnostic performance. The BBM will be assessed by using a mass spectrometry-based plasma assay (LC-MS / MS), namely the PrecivityAD™ blood test which is marketed by company C2N (www.PrecivityAD.com). This test simultaneously quantifies plasma amyloid beta (A|3) 42 and 40 (A|342 and A|340) concentrations and identifies the presence of plasma Apolipoprotein E (ApoE) isoform-specific peptides isoforms ( / .e., ApoE2, ApoE3, ApoE4 isoforms) to determine APOE genotype. The test’s statistical algorithm combines the A|342 / 40 ratio, established APOE genotype to determine status of patients’ brain amyloidosis. Studies have demonstrated that lower plasma A|342 / A|340 ratio, in combination of the well-established risk factors of AP0E4 status and age, correlate with brain amyloidosis as measured using amyloid PET imaging (references 16 and 17). Therefore, the Amyloid Probability Score (APS) based on the plasma A[342 / 40 ratio, APOE genotype (determined by the ApoE peptide isoforms) and patient age will be assessed to select patients having higher probability of brain amyloid burden. Subjects having a A[342 / 40 Ratio >0.089, the presence of apoE4 allele, and an APS ranging from 58-100 will be selected (see Table 1 below). The amyloid Probability Score (APS) represents the estimated likelihood from 0 (low likelihood) to 100 (high likelihood) that the patient is currently positive to amyloid PET imaging (presence of amyloid plaques) based on their A|342 / 40 ratio, age, and established APOE genotype.

[0143] Table 1:

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[0148] Example 1.2: Indications for use

[0149] The non-invasive medical device according to the present invention is in the form of a headmounted wearable non-invasive device which may be placed on the head, in direct contact with the scalp and / or skull of a subject, thereby allowing homogeneous and reliable exposure of the cortex of the subject to said electromagnetic waves either alone or in combination with red and near-infrared lights. It is self-contained and has been designed for in-home daily treatment, allowing for complete mobility and comfort in performing daily activities during treatment. The device has a custom control panel that is powered by a rechargeable battery. This control panel / battery box may be worn on the upper arm and wired to specialized antennas in the headset worn by the subject. For each day of in-home treatment, the subject wears the headset for two one-hour treatment: 1-hour in the morning and 1-hour in the afternoon or evening with at least a 7-hour rest in between the treatment.

[0150] Example 1.3: Exploratory clinical phase and Intended outcomes and clinical benefits for Alzheimer’s disease patients

[0151] It is expected that Alzheimer's patients, most likely at the mild-to-moderate stage may see some improvements in one or more the following outcomes compared to baseline, after at least 2-month treatment with the medical device according to the present invention. This is expected to be reflected in a lesser burden for the caregiver and improved quality of life of the patients and family. In particular, changes from baseline at 2 months into treatment, in one of the following symptoms, mood and behavioral symptoms, depression, anxiety, irritability, inappropriate behavior, sleep disturbance, psychosis, and / or agitation are particularly expected.

[0152] Impact on Mini-Mental State Examination (MMSE)

[0153] MMSE is a brief, structured test of mental status that takes about 10 minutes to complete. It involves 11 questions that check for thinking, communication, understanding, and memory impairments. Specifically, the MMSE assesses six areas of mental abilities orientation of time and space, attention and concentration, short-term memory recall, language skills, visuospatialabilities, ability to understand and follow instructions: The person may be given a series of tasks while their ability to follow instructions is evaluated.

[0154] Scores on the MMSE range from 0 to 30, with scores of 25 or higher being traditionally considered normal. Scores less than 10 generally indicate severe impairment, while scores between 10 and 20 indicate moderate dementia. People with early-stage Alzheimer's disease tend to score in the 20 to 25 range.

[0155] Mild-to-moderate Alzheimer’s subjects having above 65 years old and scoring between 16-26 at the MMSE are expected to show some improvements to their cognitive impairment.

[0156] Impact on Alzheimer's Disease Assessment Scale-cognitive Subscale 14 (ADAS-Coq-Plus or ADAS-Cog14)

[0157] Alzheimer's Disease Assessment Scale-Cognitive Subscale 14 (ADAS-Cog14) is one of the most widely used cognitive scales in clinical trials and is the "gold standard" for assessing antidementia treatments. ADAS-Cog14 consists of 14 competencies: word recall, commands, constructional praxis, object and finger naming, ideational praxis, orientation, word recognition, remembering word recognition instructions, comprehension of spoken language, word finding difficulty, spoken language ability, delayed word recall, number cancellation, and maze task. The ADAS-Cog14 scale ranges from 0 to 90. Higher scores indicate greater cognitive impairment.

[0158] Alzheimer’s disease subjects treated with the medical device according to the present invention are for at least a 2-month are expected to present enhanced cognitive performance. Indeed, compared to baseline, the average performance in the ADAS-cog14 is expected to improve by over 4 points following 2-month treatment.

[0159] Impact on Quality-of-Life Scale in Alzheimer's disease (QOL-AD)

[0160] The QOL-AD is a standard quality of life measure that asks parallel questions of Alzheimer’s disease patients and their caregivers. The QOL-AD is a series of questions designed to be administered to individuals with dementia, to obtain a rating of a patient's quality of life from both the patient and the caregiver. It includes assessments of the individual's relationship with friends and family, concerns about finances, physical condition, mood, and an overall assessment of life quality.

[0161] Impact on the Neuropsychiatric Inventory (NPI) score

[0162] NPI is a well-validated, reliable, multi-item instrument to assess psychopathology (e.g., behavioral symptoms) in AD based on a questionnaire completed by the participants' study partners / based on a standardized caregiver interview.

[0163] NPI assesses the frequency, severity and level of distress caused by 12 common dementia-related behaviors: delusions, hallucinations, agitation / aggression, depression / dysphoria,anxiety, elation / euphoria, apathy / indifference, disinhibition, irritability / lability, aberrant motor behavior, sleep, and appetite / eating.

[0164] Impact on Electroencephalogram's (EEG) and attention’s span

[0165] The EEG recordings will give insight into the effect on the neural activity of the brain. It is recognized that Alzheimer's patients generally experience a slowing of their EEG activity with EEG waves as slow as theta or delta neuronal waves. It is expected that Alzheimer's patients undergoing treatment with the medical device according to the present invention increase their neuronal activity to alpha waves as well as their attention to their direct environment and discussions with their caregivers and family.

[0166] Impact on EQ-5D European Quality of Life Scale

[0167] The EQ-5D is a standardized instrument for use as a measure of health outcomes. It includes measures of mobility, self-care, usual activities, pain / discomfort, and anxiety / depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems.

[0168] The EQ visual analogue scale (VAS) records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. This information can be used as a quantitative measure of health as judged by the individual respondents.

[0169] Impact on ADSL-ADL: Alzheimer's Disease Cooperative Study Activities of Daily Living ADCS-ADL assesses the competence of patients with AD in basic and instrumental activities of daily living (ADLs). It can be completed by a caregiver in questionnaire format or administered by a clinician / researcher as a structured interview with a caregiver. ADCS-ADL scores range from 0-53, with higher scores indicating greater independence.

[0170] Impact on sleep time / sleep efficiency

[0171] This can be easily assessed by analyzing the sleep data reported by an Actigraph activity monitor. The activity monitor may be attached to a wristband and worn by the subject through the study completion. Treated Alzheimer's disease patients are expected to show less agitation and anxiety in the late afternoon and to experience a better quality of their sleep.

[0172] Alzheimer’s disease subjects treated with the non-invasive medical device according to the present invention for at least a 2-month are expected to present improvements in one or more of the above tests and scores compared to baseline.

[0173] Impact of the treatment on the improvement of the conditions of the Alzheimer’s patients may be followed by other clinical endpoints such as change in Caregiver Burden Inventory (CBI), in Positive Aspects of Caregiving Scale, in the clock-drawing test, in the CTT2 / CTT1: in the performance on Color Trails Test, in GDS: Geriatric Depression Scale for caregivers, change in Positive Aspects of Caregiving scale, in ADL SAD or ADSC-ADL-sev: Alzheimer's DiseaseCooperative Study - Activities of Daily Living for Severe Alzheimer's Disease score, in the Digit Span forward and Digit Span backward score.

[0174] Impact on digital biomarkers

[0175] Assessment of the impact of the treatment with the medical device according to the present invention may be made by using digital biomarkers. These include real-time, continuous, and non-invasive home-based assessment of health-relevant activity and behavior using the Collaborative Aging Research Using technology (CART) platform developed by the Oregon Center for Aging & Technology (ORCATECH).

[0176] The CART platform is a multi-functional digital technology platform allowing to assess in realtime and in a non-obtrusive manner the health and wellness of Alzheimer’s patients. The platform comprises ambient technology, wearables, and other sensors installed in the homes of Alzheimer’s patients. The sensors include for example passive infrared sensors (motion activity detectors) which monitor the walking speed as well as the amount of time participants spend in each room of their home and how often they move around in their home; actigraphy watches are provided to measure the total activity; electronic pillboxes recording when and which pillbox doors are opened / closed; contact door sensors monitoring the amount of time spent outside of their homes, etc.

[0177] Such variety of home-based sensors are thus used to monitor the impact of the treatment with the medical device according to the present invention inter alia on the walking speed, the sleep activity, activity and social engagement, i.e., time out of the home, mobility patterns of the patients within their homes (e.g., reflecting agitation, apathy, depression), computer use, medication-taking adherence, driving patterns, metadata from online behavior. Alzheimer's patients and their caregivers are expected to notice a decrease in agitation and anxiety, and improvement of sleep, a higher attention span which may improve computer use, social engagement, medication-taking adherence.

[0178] Impact on fluid biomarkers upon completing at least 2-month treatment

[0179] Following plasma levels of a combination of biomarkers allows precise monitoring of the disease progression and treatment response.

[0180] Several tests either based on the Elisa technique or mass spectrometry may be used. By way of example, the PrecivityAD2™ blood test from the company C2N (www.PrecivityAD.com) is used to measure plasma A|342 and A|340, as well as plasma total tau (T-tau), and plasma phosphorylated tau 217 (pTau217) and calculate the plasma Ab42 / 40, plasma pTau217 / non-phospho-tau217 ratio, and Amyloid Probability Score-2. Indeed, the ratio plasma A|342 / A|340 has been shown to reflect amyloid removal. Also, plasma p-tau217 reduction was evidenced to correlate with changes in amyloid and tau load (references 22-23). In addition, plasma biomarkers A|342, A|340, Glial Fibrillary Acidic Protein (GFAP) and Neurofilament light chain(Nf-L) are measured using the Simoa multiplex Bead-Based Advantage Assays of Quanterix (Neurology 4-Plex E; catalog numbed 03670) to monitor the effects of the disease modifying treatment at 2 months after treatment.

[0181] Decreased levels of AP1-42 peptide in CSF and increased levels of plasma AP1-42 peptide occur in conjunction with cognitive decline. The change score may thus be determined by calculating the ratio of plasma AP1-42 peptide after treatment over baseline. Also, increased levels of A[3i 40 and AP1-42 soluble monomeric peptides and of oligomeric A|3 aggregates are expected to peak in the blood and cerebrospinal fluid (CSF) of subjects after completion of the 2-month treatment with a medical head device according to the present invention. Therefore, monitoring the change in the ratio of AP1-42 / AP1-40 may be indicative of the efficiency of the treatment. Tau protein forms insoluble filaments that accumulate as neurofibrillary tangles (NFT) in AD. At least 2 months of treatment with the non-invasive medical device of the present invention is expected to result in some increase in plasma t-tau (total tau protein) levels, since it induces the dissociation of the tau tangles and thus an increase in monomeric tau within plasma of the treated Alzheimer disease subjects. The change score is determined by calculating the ratio of plasma and CSF tau after treatment over the baseline plasma tau levels.

[0182] In the same way following the levels of neurofilament light (NF-L) is indicative of the stabilization and / or reversal of the disease since NF-L is released in significant quantity following axonal damage or neuronal degeneration. The change score is determined by calculating the ratio of plasma or CSF levels of NfL after treatment over the baseline levels of NfL in plasma and CSF, respectively.

[0183] Example 2: Pilot clinical phase for testing safety and efficacy of the non-invasive medical head device on mild cognitive impairment (MCI) and amnestic mild cognitive impairment (aMCI)

[0184] The objectives are to evaluate cognitive the use of the non-invasive medical device may have neural impacts on MCI and aMCI during a pilot feasibility study. Participants having more than 50 years old and meeting the National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for MCI or aMCI due to Alzheimer's disease may be enrolled. The patients undergo a 2-month trial of the daily treatment at home each for 20 minutes per session. All patients undergo clinical and cognitive assessment, blood sample collection, and structural and resting state functional MRI scans pre and post treatment.

[0185] Several outcome measures may be used for monitoring the efficiency of the treatment of patients affected by MCI or aMCI, such as changes from pre- to post-treatment on mental status and cognitive function assessed by Mini-Mental State Examination (MMSE), changes from pre- to post-treatment on verbal learning and memory assessed by California VerbalLearning Test II (CVLTII), changes from pre- to post-treatment on visuospatial memory assessed by Brief Visuospatial Memory Test Revised (BVMT-R), changes from pre- to posttreatment on processing speed assessed by Trail Making Test (TMT)-part A, and / or changes from pre- to post-treatment on Quality of life using QOL-AD.

[0186] Example 3: Pilot clinical phase for testing safety and efficacy of the non-invasive medical head device on Parkinson’s disease

[0187] This is a pilot study of the efficacy of the non-invasive medical head device according to the present invention to slow down the neurodegenerative process, protect dopaminergic neurons, reduce the symptoms patients with Parkinson's Disease (PD) experience, and to enhance cognition and mood in individuals with Parkinson disease. The overall hypothesis is that use of the medical head device has positive effects on brain health, enhancement of neurons, neuroprotection, better cognitive and mood performance.

[0188] Patients having more than 18 years old, with Idiopathic Parkinson's disease H & Y 1-3 (Hoehn&Yahr), and MMSE score above 22 may be enrolled.

[0189] Parkinson subjects treated with the non-invasive medical device according to the present invention for at least a 2-month are expected to present improvements in one or more of the following outcome measures compared to baseline: Change from baseline in motor clinical signs progression evaluation (Scores on the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale), non-motor behavioral signs progression evaluation (Scores on the non-motor scales Behavioral Evaluation in Parkinson's disease), non-motor clinical signs progression evaluation (Scores on the non-motor scales Lille Apathy Rating Scale), evolution of the quality of life (Parkinson Disease Quotation (PDQ-39) quiz score), assessment of tremor, akinesia and stiffness, speech, walking and balance disorders, walking speed evaluation and of walking parameters (score in the "freezing of gait" questionnaire), as well as ARENA, learning and memory change from baseline to post-testing, learning and memory change from baseline to post-testing.

[0190] Example 4: Pilot clinical phase for testing safety and efficacy of the non-invasive medical head device on traumatic brain injury

[0191] The purpose of this study is to examine effectiveness of an at-home use of the non-invasive medical head device according to the present invention on mild-moderate traumatic brain injury cases. Participants are expected to complete two months of treatment at home 3 times to 6 times a week. Each home treatment is 30 minutes. Participants are randomized. Group 1 receives both a series of sham and a series of real treatments and Group 2 receives two seriesof real treatments. Sham and Real devices are identical in look and feel, except no or very little electromagnetic signals and photons are emitted from the sham head devices.

[0192] Each participant is assigned his / her own medical head device for hygiene reasons. The assigned device will be provided to each participant at a 1-hour in-office training session, after the first Neuropsychological (NP) Testing. Training that includes both verbal and written instructions will be provided, along with demonstration of use of the device. A treatment log, storage box and alcohol wipes for cleaning are provided. The first treatment is completed at the training session.

[0193] A staff person will telephone each participant weekly, to fill out a questionnaire about the intervention including inquiring if the treatments are being performed, if the treatment log sheets are being filled out, and note if there are any questions, concerns or problems.

[0194] Neuropsychological testing and structural and functional MRI (fMRI) scans are administered to examine behavioral and brain changes before and after the treatment. MRI scans examine some mechanism of treatment including changes in blood flow, functional connectivity and neurochemicals.

[0195] Outcome measures include functional MRI: resting-state functional-connectivity Magnetic Resonance Imaging (rs-fc MRI), California Verbal Learning Test (CVLT), Long-Delay Free Recall (LDFR) is the Primary Outcome Measure which examines verbal learning, organization and memory. The subtest LDFR, CVLT-II specifically assesses long-delay (20 min), verbal memory, which can be affected after brain injury.

[0196] Example 5: Pilot clinical phase for testing safety and efficacy of the non-invasive medical head device on migraine headaches

[0197] This pilot study aims to validate the efficiency of the non-invasive medical head device for treatment in patients with migraine and tension-type headache symptoms. Various physiological measurements are taken before, during, and after the treatments, including skin type, weight, height, blood pressure, and heart rate. Additionally, data from questionnaires on pain and headache symptoms will be analyzed. This addresses the need for effective pain management strategies in cases where medication-based treatments may have unwanted side effects. Outcome measures include headache pain as assessed using the Visual Analog Scale from zero to 10.

[0198] Example 6: Pilot clinical phase for testing safety and efficacy of the non-invasive medical head device on tinnitus

[0199] The aim is to determine the effectiveness of the non-invasive medical head device for mitigating and / or alleviating tinnitus. Patients who have unilateral tinnitus for at least 3 monthsmay be enrolled. They follow at home treatment with the medical head device for 1 to 2 months, for 20-30 min daily. Efficiency of the treatment is assessed by numerical estimates of tinnitus severity before and after treatment.

[0200] Example 7: Pilot clinical phase for testing safety and efficacy of the non-invasive medical head device on depression

[0201] The objective is to validate the efficiency of the non-invasive medical head device on a cohort study of patients having depression, refractory to antidepressant drugs and / or with a score on Hamilton Depression Scale (HAM-D17) above 17. Patients may use the medical head device daily for 1 to 2 months, 20-30 min per session. The outcome measures include the change in the Hamilton Depression Scale (HAM-D17), life quality (WHO-5 scale), response and remission.

Claims

1. CLAIMS1. Body tissue RF applicator element (50) configured for emitting one or more electromagnetic signals in a frequency ranging from 30 MHz to 1000 MHz, said applicator element (50) being divided into at least two sections or halves (70, 70’) located on either side of a central connector element (9), wherein each of said at least two sections or halves (70, 70’) comprises at least two segments (70A, 70B, 70C, 70D), each of said segments comprising one or more meander structures (5).

2. The body tissue RF applicator element (50) according to claim 1 , wherein each of the at least two sections or halves (70, 70’) located on either side of a central connector element (9) has, in top view onto the respective section or half (70, 70’), a substantially concave lensshaped circumference.

3. The body tissue RF applicator element (50) according to any one of the preceding claims, wherein each of said at least segments has, in top view onto the respective section or half (70, 70’), a substantially triangular-shaped or arrow- or pointer-shaped circumference.

4. The body tissue RF applicator element (50) according to any one of the preceding claims, wherein said one or more electromagnetic signals has a frequency ranging from 30 MHz to 200 MHz, 40 MHz to 100 MHz, 50 to 70 MHz, or around 60 MHz, or 64 MHz, or ranging from 850 MHz to 950 MHz, from 800 MHz to 930 MHz, from 850 MHz to 915 MHz or from 910 MHz to 920 MHz.

5. The body tissue RF applicator element (50) according to any one of the preceding claims, wherein the body tissue RF applicator element (50) is configured for emitting said one or more electromagnetic signals as pulsed electromagnetic signals, and wherein the repetition rate of said one or more pulsed electromagnetic signal is in a range of from 20 to 100 Hz, in a range of from 100 to 200 Hz, in a range of from 30 to 50 Hz, in a range of from 90 to 110 Hz or in a range of from 190 to 210 Hz.

6. The body tissue RF applicator element (50) according to any one of the preceding claims, wherein said at least two sections or halves (70, 70’) are positioned in a mirrored and opposite arrangement relative to a central axis.

7. The body tissue RF applicator element (50) according to any one of the preceding claims, comprising at least two mutually symmetrical triangular segments (70A, 70B, 70C, 70D) positioned in a mirrored and opposite arrangement relative to a central axis.

8. The body tissue RF applicator element according to at least one of the previous claims further comprising one or more mounting locations (6) for mounting LLLs and / or LEDs, said one or more mounting locations (6) being preferably positioned along a center line of a respective section or half (70, 70’).

469. The body tissue RF applicator element (50) according to any one of the preceding claims, further comprising one or more LEDs and / or LLLs mounted at said mounting locations (6), said LEDs and / or LLLs being configured for emitting red and / or near-infrared signals.

10. The body tissue RF applicator element (50) according to claim 9, wherein said red signals have a wavelength in a range from 620 to 680 nm and / or said near-infrared signals have a wavelength in a range from 800 to 1100 nm.

11. The body tissue RF applicator element (50) according to claim 9 or 10, wherein the body tissue RF applicator (50) is configured to emit said red signals and / or said near-infrared signals as pulsed signals.

12. The body tissue RF applicator element (50) according to claim 11 wherein the pulsed signals have a repetition rate in a range of from 10 Hz to 100 Hz, from 10 to 60 Hz, from 10 to 30 Hz such as 20 Hz, or from 30 to 50 Hz such as 40 Hz; and / or wherein the pulsed signals emitted by different LEDs and / or LLLs either all have the same repetition rate or that at least two or all these LEDs have a different repetition rate.

13. The body tissue RF applicator element (50) according to any one of the preceding claims, wherein the applicator element (50) is made of or built on a flexible printed circuit board such as a curved flexible printed circuit board.

14. A wearable head device comprising one or more body tissue radiofrequency applicator elements (50) according to any one of the preceding claims.

15. The wearable head device according to claim 14, wherein said device is configured to fit on head of a human subject, and wherein the arrangement of the one or more body tissue RF applicator elements (50) is such that they are adjacent to said head when the head device is worn by said human subject.

16. The wearable head device according to claim 14 or 15, wherein the one or more body tissue RF applicator elements (50) are embedded within said head device or are located on a fabric of said head device.

17. The wearable head device according to any one of claims 14 to 16, wherein the device comprises a central controller configured to control and / or supply energy to the one or more body-tissue RF applicator elements (50), the controller being electrically connected to each of the one or more body-tissue RF applicator elements (50)18. The wearable head device according to anyone of claims 14 to 17, wherein said device is a medical head device or a wellness head device.

19. The wearable head device according to anyone of claims 14 to 18, wherein said device is a non-invasive neuromodulation device.

20. The wearable head device according to anyone of claims 14 to 19, wherein said device comprises one or more neurological sensors, one or more processing units, and one or more wireless communication modules.

21. The wearable head device according to any one of claims 14 to 20, wherein said one or more neurological sensors comprise electroencephalogram (EEG) electrodes, near-infrared spectroscopy sensors, and / or magnetometers.

22. The wearable head device according to anyone of claims 14 to 21, wherein said device comprises a wearable cap.

23. Body tissue RF applicator element according to any one of claims 1 to 13 or of head device according to any one of claims 14 to 22 for use in a method of:(i) treating, preventing, stabilizing and / or reversing the symptoms of dementia and / or neurodegenerative diseases such as Alzheimer’s disease, mild cognitive impairment, cerebral amyloid angiopathy Parkinson’s disease, Lewy body dementia, vascular dementia, and / or frontotemporal dementia;(ii) treating, preventing and / or alleviating traumatic brain injury (TBI), concussions, and other types of neurological conditions; or(iii) treating, preventing and / or mitigating depression, migraine headaches, myodesopsia, and / or tinnitus.

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