Phototherapy system and method for sexual dysfunction

Abstract

Systems and methods for treating sexual dysfunction using transcranial photobiomodulation (t-PBM) with near infrared light (NIR) are provided. In particular, a device configured to treat a disease in a subject can have a power source and a light source configured to receive power from the power source to cause the light source to emit near infrared light, where the near infrared light has a wavelength of 600 nm - 1400 nm. The device has a processor and a housing configured to house the light source to deliver the near infrared light to an area of interest in the subject to treat the disease by transcranial photobiomodulation for a sufficient dose and duration.

Description

[0001] Cross-reference of related applications

[0002] This application is based on and claims priority to U.S. Patent Application Serial No. 62 / 483,632, filed April 10, 2017, the entire contents of which are incorporated herein by reference. Background Technology

[0003] This invention generally relates to methods and systems for treating erectile dysfunction, and more specifically, to systems and methods for treating erectile dysfunction by photobiological modulation (t-PBM) with far-infrared light (NIR).

[0004] Sexual dysfunction is common, affecting approximately 43% of women and 31% of men in the United States. Sexual dysfunction may involve decreased libido (sexual desire), inadequate sexual arousal—such as incomplete penile or clitoral engorgement or lack of vaginal lubrication—and delayed or absent orgasm (anesthesia) or a combination thereof.

[0005] The causes of sexual dysfunction are varied, including psychological, neurological, endocrine, cardiovascular, and cervical conditions, as well as common prescription medications. While any of the above-listed causes may be sufficient to cause sexual dysfunction, it is more common for multiple causes to contribute. Consider major depressive disorder (MDD) (a common cause of sexual dysfunction, affecting up to 50% of untreated depressed individuals), which often co-occurs with other physical conditions and is at least twice as prevalent in patients with at least two other chronic conditions. The same patient may be taking medications for MDD or other conditions, or taking health supplements or medications such as oral contraceptives. Therefore, it is clear that sexual dysfunction can have multiple co-existing causes, such as psychological illness, other conditions, and medication treatments, whether the medication is prescribed to treat the same condition or taken for general health reasons. The patient sample of sexual dysfunction described below illustrates the multifactorial nature of sexual dysfunction.

[0006] There are various treatments available for sexual dysfunction in both women and men; however, patients are increasingly seeking alternative drug and non-drug interventions to treat their condition, requiring alternative scientific discoveries that will change current medications for treating sexual dysfunction.

[0007] Therefore, at least one objective of the present invention is to overcome these defects and problems. Summary of the Invention

[0008] This disclosure overcomes the aforementioned deficiencies by providing a photobiological modulation (PBM) system and method incorporating near-infrared light (NIR) and including transcranial PBM (t-PBM). Using the systems and methods described herein, mitochondria absorb NIR and enhance cellular energy metabolism. According to the invention, non-limiting benefits of t-PBM include cognitive enhancement, antidepressant, and anti-anxiety effects. However, the systems and methods provided herein are specifically designed for implementing PBM to treat sexual dysfunction and have demonstrated effectiveness in patients with medical and psychological comorbidities and concomitant pharmacological therapy for depression.

[0009] According to one aspect of the invention, a device is configured to treat a subject's sexual dysfunction. The device includes a power source and a light source, configured to receive power from the power source causing the light source to emit near-infrared light having a wavelength of 600 nm-1400 nm, and also includes a processor. The device further includes a housing configured to contain the light source, delivering the near-infrared light to a region of interest for the subject, thereby treating the subject's sexual dysfunction through transcranial photobiological modulation of sufficient dose and duration.

[0010] According to another aspect of the invention, an apparatus configured to treat a disease of a subject is provided. The apparatus includes a power source and a light source, configured to receive power from the power source and cause the light source to emit near-infrared light. The near-infrared light has a wavelength of 600 nm to 1400 nm. The apparatus also includes a processor and a housing configured to house the light source and deliver the near-infrared light to a region of interest of the subject, thereby treating the disease through transcranial photobiomodulation of sufficient dose and duration.

[0011] In some respects, the disorder is a sexual dysfunction. In other respects, the disorder is at least one of impaired libido, impaired sexual arousal, delayed or absent orgasm. Near-infrared light can be one of the following: a wavelength of approximately 825 nm, a wavelength of approximately 850 nm, or a wavelength from approximately 808 nm to approximately 830 nm. Near-infrared light delivery can last from approximately 1 minute to approximately 120 minutes per day. Near-infrared light can have an average radiation of 36.2 mW / cm² at a wavelength of 830 nm. 2 The flux reached 65.2 J / cm³ in 30 minutes. 2 Delivery, treatment window is 28.7cm 2 .

[0012] According to another aspect of the invention, a method for controlling a device configured to treat a disease of a subject is provided. The method includes: supplying power to the device having a light source, such that the light source emits near-infrared light having a wavelength of 600 nm to 1400 nm to a region of interest in the subject. The method further includes delivering the near-infrared light to the region of interest in the subject via transcranial photobiomodulation, the dose and duration of which are sufficient to treat the disease.

[0013] In some respects, the disorder is a sexual dysfunction. In other respects, the disorder is at least one of impaired libido, impaired sexual arousal, delayed or absent orgasm. Near-infrared light can be one of the following: a wavelength of approximately 825 nm, a wavelength of approximately 850 nm, or a wavelength from approximately 808 nm to approximately 830 nm. Near-infrared light delivery can last from approximately 1 minute to approximately 120 minutes per day. Near-infrared light can have an average radiation of 36.2 mW / cm² at a wavelength of 830 nm. 2 The flux reached 65.2 J / cm³ in 30 minutes. 2 Delivery, treatment window is 28.7cm 2 . Brief description of the attached figures

[0014] Other objects, features, and advantages of the invention will become clearer from the following detailed description and the accompanying drawings showing illustrative embodiments, wherein:

[0015] Figure 1 This is a schematic diagram illustrating the transcranial photobiomodulation device according to this instruction manual.

[0016] Figure 2 It's a flowchart, which provides a way to... Figure 1 Examples of non-limiting steps in a method for transcranial photobiological modulation of a system.

[0017] Figure 3 The total SAFTEE sexual score shows the effect of t-PBM on sexual dysfunction in all samples over time.

[0018] Figure 4 The total SAFTEE sexual score shows the effect of t-PBM on sexual dysfunction in all participants over time.

[0019] Figure 5 It is the total SAFTEE score scale before and after treatment.

[0020] Figure 6 It is the total SAFTEE sex score for all women and all men before and after treatment.

[0021] Figure 7 It is a scoring system for all samples of impaired libido, impaired sexual arousal, and impaired orgasm before and after treatment.

[0022] Figure 8 It is a rating scale for impaired libido, impaired sexual arousal, and impaired orgasm before and after treatment.

[0023] The following detailed description of the invention is given by way of example but is not intended to limit the invention to the specific embodiments described herein, which can be understood in conjunction with the accompanying drawings, which are incorporated herein by reference. Detailed Implementation

[0024] In this article, the terms "treatment," "management," etc., refer to reducing or alleviating a condition, such as sexual dysfunction and / or brain disorders and / or their associated symptoms. It should be understood that, while not exclusionary, treatment of brain disorders does not require the complete elimination of the condition, symptom, or its associated symptoms.

[0025] Unless otherwise expressly stated or clearly indicated from the context, the term “about” as used herein shall be understood to mean a range normally permissible in the art, such as within two standard deviations of the mean. “About” can be understood as within 10%, 9%, 8%, 7%, 6%, 5%, 4%, 3%, 2%, 1%, 0.5%, 0.1%, 0.05%, or 0.01% of the values ​​shown. Unless otherwise expressly stated herein, all numerical values ​​provided herein are modified by the term “about.”

[0026] As used herein, the term "effective" means sufficient to achieve the desired, expected, or intended result. When used to describe the use of a compound to treat a subject or patient, "effective amount," "therapeutic effective amount," or "drug effective amount" refers to an amount of compound that is sufficient to treat the disease when administered to the subject or patient.

[0027] As used in this article, the term "transcranial photobiomodulation" refers to the use of several therapeutic techniques that employ infrared, low-level laser, and / or LED light to treat diseases across or through the skull.

[0028] Figure 1 An exemplary device 100 is shown, comprising a power supply 101 and a light source 102, the power supply 101 being configured to provide power to the light source 102. At least one light source 102 is included in the system, thus a plurality of light sources 102 can be included in the device 100. The light source 102 may be a light-emitting diode (LED) source, which may include a single LED or an LED array. In a non-limiting embodiment, the light source 102 may emit NIR light of a predetermined wavelength toward a region 132 of interest of the object 130. In a non-limiting embodiment, the light source 102 may emit NIR light at a wavelength of 830 nanometers (nm) with an average radiation of 36.2 mW / cm². 2 The flux reached 65.2 J / cm³ in 30 minutes. 2 The treatment window is 28.7cm. 2 / System 102. In some embodiments, two devices 100 may be implemented, with the device 100 positioned to directly apply NIR to regions of interest on both sides of the forehead, which may be the F3 and F4 regions of the dorsolateral prefrontal cortex (dlPFC) (according to the EEG localization map). As other or alternative non-limiting examples, other forehead sites, such as Fp1 or Fp2 or other sites on the forehead or other regions, may be used.

[0029] A block diagram showing an example of a controller 120 that can be integrated into device 100 to perform the methods described herein. Controller 120 is typically equipped with a hardware processor 104 and a memory 106.

[0030] Controller 120 typically includes an input device 103, at least one hardware processor 04, memory 106, and output device 108. Controller 120 may also include any suitable means for reading computer-readable storage media. In some embodiments, controller 120 may be operated by a workstation, notebook computer, desktop computer, mobile device, multimedia device, network server, mainframe computer, one or more controllers, one or more microcontrollers, or other general-purpose or special-purpose computing device. Controller 120 may operate automatically or semi-automatically, or may read executable software instructions from memory 106 or computer-readable media (e.g., hard disk, optical disk, flash memory), or accept instructions via input device 103 from a source logically connected to a user or other computer or device (e.g., another networked computer or server).

[0031] In general, controller 120 is programmed, or otherwise configured, to perform the methods and algorithms described below. For example, controller 120 is programmed to provide power to light source 102 via power supply 101 to emit near-infrared light according to any dose, duration, or pulse sequence described herein. In a non-limiting example, LEDs and laser devices may be used. Additional or alternative wavelengths of 600-1400 nm may be used. A given dose may be delivered continuously and / or pulsed (CW or PW) at 1-300 Hz (approximately 10 Hz, 20 Hz, 30 Hz, 40 Hz). Average radiation may be, for example, 10-750 mW / cm². 2 The average flux can be, for example, 10-160 J / cm³. 2 As another example, treatment duration can range from 1 to 120 minutes per day.

[0032] The input device 103 can be of any suitable shape or form as needed for operating the controller 120, including the ability to select, input, or otherwise define parameters consistent with performing tasks, processing data, or operating the controller 120. In some aspects, the input device 103 can be configured to accept data, such as data obtained through a user interface. This data can be processed as described above to determine the correct dose, duration, pulse sequence, or any other test variable.

[0033] Memory 106 may contain software 110 and data 112, such as data obtained from a user interface, and may be configured to store and receive processed information, instructions, and data to be processed by one or more hardware processors 104. In some aspects, software 110 may contain instructions intended to emit near-infrared light as desired by various organs and / or systems within the head or other parts of the object.

[0034] Figure 2 An exemplary method of the specification is shown. The method may include step 200 of placing a light source, such as light source 102, to deliver near-infrared light to a region of interest, such as region 132 of object 130. Step 201 of the method may include a control device, such as device 100, to select and / or configure the device to deliver a therapeutically effective dose to the subject. Device 100 may have the aforementioned light source 102, and the power supplied to device 100 may be sufficient to cause light source 102 to emit near-infrared light to region 132 of object 130. A non-limiting example of a therapeutically effective dose may be about 0.1-5 kJ per treatment, or about 2.4 kJ or 3.4 kJ per treatment. Each treatment may be weekly, daily, or several times a day, for example, twice a day or varying between treatments. Step 202 of the method may be the delivery of near-infrared light to region 132 of the subject via transcranial photobiomodulation, with a dose and duration sufficient to treat the disease.

[0035] In some configurations, near-infrared light may have wavelengths from 600 nm to 1400 nm. More specifically, the configuration or control device may include generating near-infrared light at wavelengths of approximately 825 nm, approximately 850 nm, or approximately 808 nm to approximately 830 nm. Furthermore, the configuration or control may include causing the device's processor to control the light source to deliver near-infrared light for a period of approximately 1-120 minutes per day. In a non-limiting example, the device may be configured and / or controlled to deliver near-infrared light at a wavelength of 830 nm, with an average radiance of 36.2 mW / cm². 2 The flux reached 65.2 J / cm³ in 30 minutes. 2 The treatment window is 28.7cm. 2 Therefore, the effective dose of the treatment can effectively treat sexual dysfunction, which may include at least one of impaired libido, impaired sexual arousal, delayed or absent orgasm.

[0036] The following provides information about a study of a non-limiting example of performing and displaying this specification.

[0037] Methods and Materials

[0038] Inclusion and Exclusion Criteria

[0039] Adults (18–65 years of age) meeting the criteria for Structured Clinically Reported Disorders (SCID) related to MDD in the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) and having a depression severity rating of at least moderate (Hamilton Depression Scale, HAM-D17 total score of 14–24) were included in the study after providing written informed consent. At this stage, participants may have failed no more than one FDA-approved antidepressant treatment (for at least 6 weeks) and no more than one phase of structured psychotherapy for depression (for at least 8 weeks). Other exclusion criteria included spontaneous substance abuse disorder (within the first 6 months), lifetime psychotic episodes, bipolar disorder, suicidal ideation and homicidal ideation, unstable symptoms, and recent stroke (within the first 3 months). Women of risk of pregnancy, especially sexually active women, were required to use contraception; pregnant or breastfeeding women were excluded. To achieve maximum light penetration and minimize the risk of local tissue damage from NIR use, the following conditions were excluded: 1. Presence of forehead skin conditions; 2. Use of photoactivated drugs (within the first 14 days); 3. Presence of head implants.

[0040] Research design and processing:

[0041] Eligible subjects were randomly assigned to an 8-week study group, receiving a double-blind NIR t-PBM sham treatment twice a week (16 treatments in total). At each treatment, NIR or sham treatment was applied to both sides of the forehead, targeting the F3 and F4 areas of the dorsolateral prefrontal cortex (dlPFC) (based on EEG localization). Clinical staff had the authority to adjust the duration of light exposure at weeks 4 and 6 (after 6 or 10 treatments each), adjusting it from 20 minutes to 25 and 30 minutes respectively, based on tolerability and efficacy. The study setup used LED light sources with an 830 nm NIR emission wavelength in each of the two devices, achieving an average radiation of 36.2 mW / cm². 2 The flux reached 65.2 J / cm³ in 30 minutes. 2 Delivery, treatment window is 28.7cm 2 Except for three participants, all others continued stable antidepressant treatment throughout the experiment; their data were excluded after the treatment was changed to concomitant antidepressant therapy.

[0042] Randomization and blind selection

[0043] For each mode, there are two types of t-PBM devices (NIR and sham treatment). In both modes, the devices appear identical (i.e., all visible and audible indicators). However, only the NIR mode t-PBM device produces therapeutic NIR energy. NIR light is invisible and therefore undetectable by the patient or physician. Research assistants used permutation modules for randomization, and different module sizes for each pair of devices ("A" and "B") to randomize the subjects 1:1. Only research assistants were able to identify each pair of devices as "A" and "B". Investigators and subjects remained unaware of the subject assignments because the labels on each device were covered before treatment. Blinding numbers for NIR and sham treatments were assigned to each marked device pair and placed in a sealed envelope at the study site. Blinding had been tested in ELATED-2 prior to the second report, and no significant correlation was found between treatment assignment and subjects' guesses about the treatment they received.

[0044] Clinical outcome measurement

[0045] The outcome measure of the secondary analysis of ELATED-2 was overall sexual dysfunction, assessed weekly using a systematic self-reported assessment using the Treatment-Effectiveness-Specific Survey (SAFTEE-SI) rating system (Levine and Schooler 1992). A list of fifty-five (55) adverse symptoms commonly or likely to be experienced during treatment was categorized by severity as zero (0) – none; one (1) – mild; two (2) – moderate; and three (3) – severe. For the SAFTEE score, three items were defined as sexual dysfunction-related: item 36 – loss of sexual interest; item 37 – problems with sexual arousal (erection or lubrication); and item 38 – delayed or absent orgasm. The scores for each of the three items were summed to produce a composite score – the total SAFTEE sexual score (0–9), representing overall sexual dysfunction, with higher scores indicating increased or worsening of the dysfunction. No conclusions were reached regarding whether sexual dysfunction was influenced by experienced major depressive disorder, concomitant medication, comorbidities or conditions, or other factors, including study participants and t-PBM. The instructions for self-assessment are actually universal: "Below is a table of symptoms that people sometimes experience. Please read each item; indicate how bothersome your symptoms are by circling the appropriate number to the right of each item."

[0046] Research Samples and Data Cleaning

[0047] The original ELATED-2 sample included twenty-one (21) randomly assigned subjects who had received at least one t-PBM. However, for this secondary analysis—a repeated measure of self-assessment—the sample was limited to 20 subjects because one subject in the original database consistently skipped answers on several rating scales during the study. This subject had a diagnosis of attention deficit disorder and reported significant difficulty concentrating in the absence of stimuli. Briefly, three subjects were excluded as part of an a-priori data purging process due to the commencement of new psychotherapy during the study. All other available data were included, regardless of withdrawal status.

[0048] analyze:

[0049] Descriptive statistics were used to describe the likelihood of conditions and treatments commonly associated with sexual dysfunction. Unpaired Mann-Whitney (two-tailed) and Pearson chi-square tests were used to compare baseline characteristics of continuous and nominal variables for the NIR and sham treatment groups, respectively. The Mann-Whitney U test (two-tailed) was also chosen to compare changes in the total severity score of sexual dysfunction (total SAFTEE sexual score) from baseline to endpoint (the last assessment) between the two study groups. The same analysis was repeated for the following subsamples: in completers, all women, and all men. For specific types of sexual dysfunction, such as impaired libido, sexual arousal, and orgasm, changes in severity scores for each of the three SAFTEE items (36, 37, and 38) were compared in all samples and completers (Mann-Whitney U test, two-tailed). Small sample size necessitated the use of nonparametric tests that do not cover changes in depression severity. As a post-hoc analysis, to better focus on whether antidepressant effects drive effects on sexual function, changes in sexual dysfunction severity and depression severity (HAM-D) were compared for t-PBM. 17 The Cohen d effect was calculated based on changes in the total score. Significant changes in sexual dysfunction and depression severity were then assessed timed, as plotting the means showed early improvement in sexual function (last assessment was performed at a specific time point, and the Mann-Whitney U test, two-tailed, was used for changes from baseline). For the initial results in sexual dysfunction, overall change was repeated after removing two subjects who were not assessed after baseline (n=18, Mann-Whitney U test, two-tailed). For all analyses, significance was defined as p≤0.05.

[0050] result

[0051] Etiology and baseline characteristics of sexual dysfunction

[0052] According to the adoption criteria, all participants (n=20) had major depressive disorder, a common cause of sexual dysfunction. It should be noted that 45% and 25% of participants in the same group were diagnosed with at least one or two other mental disorders, respectively; the most common classifications were anxiety disorders, post-traumatic stress disorder, and social anxiety disorder. Non-psychiatric medical conditions affected almost all participants (approximately 85%), many of whom may have had sexual dysfunction. Endocrine conditions were also the most common (30%), including thyroid and parathyroid diseases, as well as thyroid hormone supplementation. Neurological conditions were also quite common (30%), including a history of concussion, spinal cord injury, and chronic pain syndrome. Cardiovascular disease and metabolic syndrome (25%) included hypertension, hyperlipidemia, and obesity. One case of cervical condition was due to hysterectomy. Almost all participants (80%) had received medication. Some non-restrictive examples of prescription medications (with sexual dysfunction described as a possible side effect) include 45% of participants taking antidepressants or other psychotropic drugs, 15% taking antiepileptic drugs; and 15% taking alpha-2 agonists, diuretics, statins, or calcium channel blockers. Non-restrictive examples of medications or other drugs that could cause sexual dysfunction as a possible side effect include one patient taking narcotics and NSAIS; and women of childbearing age participating in the study requiring oral contraceptives (or using other contraceptive methods). See Table 1 for medical conditions and treatments that commonly affect sexual function and their incidence in our study sample. Overall, 90% of study participants had at least one additional explanation for their sexual dysfunction—in addition to depression or other psychological diagnoses.

[0053]

[0054] There were no significant differences between the two groups at baseline in terms of demographic and clinical characteristics, as well as concomitant antidepressant treatment, as described in more detail in the examples below. Throughout the study, all participants continued their baseline antidepressant treatment (if present), except for one participant in the t-PBM NIR group who discontinued psychotherapy at baseline.

[0055] Table 2: Demographic and clinical characteristics of the sample.

[0056]

[0057] The abbreviations used in Table 2 are as follows: AD: antidepressant; HAM-D: Hamilton Depression Rating Scale (17 items); CGI-S: Clinical Overall Severity Rating Scale.

[0058] Overall dysfunction

[0059] In the entire sample [NIR (n=9) -2.55±1.88 vs. spurious treatment (n=11) -0.45±1.21; z=2.548, p=.011)] and in the completers [NIR (n=5) -3.4±1.95 vs. spurious treatment (n=7) -0.14±1.21; z=2.576, p=.010)], the mean change in the total SAFTEE score of the subjects receiving the NIR mode of t-PBM was significantly greater than that of the subjects receiving the spurious treatment mode. Figure 3 and 4 The mean total SAFTEE score is shown across the two t-PBM groups (NIR and sham treatment) as the study progressed, across the entire sample and completers. Confirmation was made after removing two subjects from the analysis due to lack of post-treatment assessment [NIR (n=9) -2.55 ± 1.88 vs. sham treatment (n=9) -0.55 ± 1.33; z = 2.215, p = .027]. The same comparison was significant in women when the entire sample was sex-based [NIR (n=5) -3.0 ± 2.24 vs. sham treatment (n=6) -0.3 ± 0.82; z = 2.196, p = .028], but not in the smaller male sample [NIR (n=4) -2.0 ± 1.41 vs. sham treatment (n=5) -0.6 ± 1.67; z = 1.014, p = .310], see [link to study]. Figure 5 and 6 .

[0060] The improvement in overall sexual function was d = 1.33 (n = 20) and d = 1.23 (n = 18) (Cohen d test). These effects were 55% and 73% higher than those observed for reduction in depression severity [d = 0.86 (n = 20) and d = 0.71 (n = 18)]. A significant reduction in overall sexual dysfunction was recorded at the end of week 2 in all samples, but no significant reduction in depression severity was recorded [NIR (n = 9) -1.11 ± 1.17 vs. spurious treatment (n = 11) -0.09 ± 1.05; z = 1.972, p = .049]. At the end of week 3, two subjects were removed due to lack of post-treatment assessment, but a significant reduction in total sexual dysfunction rather than depressive severity was recorded [NIR (n=9) -2.11 ± 1.45 vs. spurious treatment (n=9) -0.44 ± 1.24; z = 2.313, p = .021]. The decrease in depressive severity was not significant at any time point in either sample (n=20 and n=18; it should be noted that both samples, as previously reported, had fewer participants than the original ELATED-2 sample (n=21).

[0061] Impaired libido

[0062] The mean change in SAFTEE item 36, “Lack of sexual interest,” was statistically significant across the entire sample [NIR (n=9) -1.2 ± 1.09 vs. spurious treatment (n=11) -0.4 ± 0.67; z = 1.930, p = .054], and also significant among participants [NIR (n=5) -1.8 ± 1.09 vs. spurious treatment (n=7) -0.3 ± 0.49; z = 2.276, p = .023]. The percentage decrease in the severity of “Lack of sexual interest” in the t-PBM NIR group was -79% in the entire sample and -90% in participants, respectively. Figure 7 and 8 .

[0063] Impaired sexual arousal

[0064] The mean change in SAFTEE item 37, "Problems related to sexual arousal (erection or lubrication)," was statistically significant in the entire sample [NIR (n=9) -0.8 ± 0.67 vs. spurious treatment (n=11) -0.1 ± 0.30; z=2.633, p<.001], but not significant in completers [NIR (n=5) -0.8 ± 0.84 vs. spurious treatment (n=7) -0.1 ± 0.38; z=1.659, p=.097]. The percentage decrease in the severity of "problems related to sexual arousal" in the t-PBM NIR group was -78% in the entire sample and -80% in completers.

[0065] Delayed or no climax

[0066] The comparison of the mean change in SAFTEE item 38, “delayed or absent orgasm,” was significant among completers [NIR (n=0.9) -0.6 ± 0.73 vs. spurious treatment (n=11) 0.0 ± 0.89; z=1.738, p=.08); NIR (n=5) -0.8 ± 0.84 vs. spurious treatment (n=7) -0.3 ± 0.76; z=2.228, p=.026]. The percentage decrease in the severity of “delayed or absent orgasm” in the t-PBM NIR group was -72% in the overall sample and -80% in completers.

[0067] discuss

[0068] Studies on the effects of t-PBM on sexual dysfunction have shown significant efficacy, with a reversal effect in patients with sexual dysfunction caused by multiple factors.

[0069] Three study participants reported improvements in sexual function, the extent and speed of which were anomalous. These three clinical cases (briefly reported below) led to this exploratory analysis of the presumptive effects of t-PBM on sexual function across the entire sample. We relied on the use of a composite score (total SAFTEE sexual score) to describe sexual impairment. The SAFTEE score was already included in the protocol for potential new-onset side effects associated with t-PBM; in this case, we used the SAFTEE score to track changes in sexual function over time, which was impaired on average in this group of MDD patients.

[0070] Unexpected improvements in sexual function from t-PBM were also documented in the depressive group across the full and complete sample. This finding remained significant for the female subgroup but not for the smaller male sample. Interestingly, although there were fewer men than women in this study, the magnitude of the reduction in sexual dysfunction severity was similar between the sexes, and slightly higher in men when t-PBM was received (females -75% and males -80%). It is prudent to assume a relationship between the lack of statistically significant findings in men and lack of energy.

[0071] Aspects of sexual dysfunction were tested to elucidate the factors most likely driving the overall study findings. In the entire sample, t-PBM showed the most significant improvement in sexual arousal compared to the sham treatment, while in participants, t-PBM showed the most significant improvement in libido and orgasm, but not significantly for sexual arousal. Surprisingly, after investigating the degree of improvement in each sexual aspect, similar reductions in the severity of sexual dysfunction were found across all aspects. Therefore, the interpretation that some comparisons lacked statistical significance may be due to a lack of effort; in fact, the measurement of each aspect of sexual dysfunction may have been less sensitive due to the four-point Likert scale (scores 0-3). The degree of reduction in each aspect of sexual dysfunction appeared slightly higher in participants (impaired libido -90%; impaired sexual arousal and orgasm -80%) compared to the entire sample (impaired libido -79%; impaired sexual arousal -78% and orgasm -72%). Participants may have benefited from more treatment sessions and longer exposure to t-PBM, as the exposure time increased by 20-30 minutes during the study.

[0072] The nature or cause of sexual dysfunction in our group was multifactorial; while underlying depressive symptoms were common in all patients, various other possible factors, such as comorbidities and medication, were also present. The antidepressant effect of t-PBM has been previously demonstrated in the same group—its effect on sexual dysfunction relative to its effect on the occurrence of depression. In this study, the onset and extent of the effect of t-PBM on sexual dysfunction were both faster and stronger than its effect on depression, contrary to the conclusion that any improvement in sexual function is due to the relief of depressive syndrome. Rather, t-PBM is more likely to benefit sexual function independently of the outcome of depression.

[0073] t-PBM influences sexual function in several ways. At least two unrestricted hypotheses can be followed regarding the mechanisms by which t-PBM affects sexual function. First, direct neural regulation mediates the central nervous system, more specifically targeting the prefrontal cortex (i.e., enhanced EEG activity). Second, an increase in signaling molecules mediates the effect, such as neuronal nitric oxide (NO). Not only does t-PBM increase NO through NIR, but it is also hypothesized that neuronal, intracellular, and extracellular NO in the hypothalamus is essential for puberty and fertility, and regulates GnRH and LH release.

[0074] Clinical observations drove at least part of the study, thus testing and reporting the hypothesis. During the clinical trials, neither the investigators nor the participants expected any effect of t-PBM on sexual function, which may have also increased the likelihood of detecting a signal by reducing the placebo effect.

[0075] Example

[0076] The following examples provide case designs from the research group.

[0077] Example 1

[0078] A 65-year-old divorced, retired man, father of two adult children. At the time of the study, he was in a romantic relationship but lived separately. At baseline, he rated his sexual dissipation as "severe" and his erectile dysfunction as "moderate." After two t-PBM sessions (one week each), the patient reported only "mild" loss of sexual dissipation and "mild" erectile dysfunction. Although his weekly assessments of sexual function fluctuated, after completing 15 t-PBM treatments, the patient consistently reported no erectile dysfunction and only minimal decline in sexual dissipation. During follow-up, the patient joked that his sexual relationship with his girlfriend had become so active that she had asked him to return to her apartment and stay overnight.

[0079] Example 2

[0080] A 44-year-old married woman; a professional and mother of two young children. Before joining the study, she had been taking venlafaxine 75mg daily for six weeks as an antidepressant and continued to take the medication during the study. Although she did not experience significant impairment in sexual function before starting her antidepressant treatment (despite having depression), she subsequently complained of decreased libido and lack of sexual pleasure due to venlafaxine. Before starting her t-PBM treatment, she rated her loss of libido as "severe," her arousal problems as "mild," and her delayed or absent orgasm as "moderate." After the first two treatments (1 week), her loss of libido was rated as "mild," her lubrication problems were resolved, and her delayed or absent orgasm was rated as "mild." After 10 t-PBM treatments, her sexual dysfunction was completely resolved. At the end of the study, the patient was concerned that t-PBM was not a routine intervention and considered her sexual function to be equivalent to that of adolescence.

[0081] Example 3

[0082] A 27-year-old single male in a romantic relationship reported "mild" loss of sexual interest and erectile dysfunction at baseline. During week 1, his sexual interest and arousal were normal. In week 2, only loss of sexual interest remained, rated as "mild." During the study (week 1), the patient reported a near doubling of his sexual interest and activity: he increased from 4-5 times per week to 8-9 times. After 4 t-PBM sessions (2 weeks), the patient stopped attending follow-up visits and eventually withdrew from the study.

[0083] The foregoing description is merely illustrative of the principles of the invention. Those skilled in the art will understand various changes and variations to the described embodiments upon reading this document. Therefore, it should be understood that those skilled in the art can design various systems, arrangements, and methods, and although these arrangements are not explicitly described or shown herein, they all embody the principles of the invention and are included within the inventive concept and scope. Furthermore, prior art, unless specifically incorporated herein by reference, is also incorporated herein in its entirety. All publications cited above are incorporated herein by reference in their entirety.

Claims

1. An apparatus configured to treat sexual dysfunction in a subject, the apparatus comprising: a power source; a light source configured to receive power from the power source causing the light source to emit near infrared light; a processor; and a housing configured to house the light source, deliver the near infrared light to an area of interest in the subject, treat the sexual dysfunction in the subject by transcranial photobiomodulation of the near infrared light for a sufficient dose and duration, wherein the sexual dysfunction comprises at least one of impaired sexual desire, impaired sexual arousal, delayed or no orgasm, and 2. The apparatus of claim 1, wherein the subject has depression, and wherein the near infrared light delivered to the subject is configured to treat the sexual dysfunction in the subject in a manner independent of treating the depression in the subject. Near-infrared light, with a wavelength of 830 nm, has an average radiation of 36.2 mW / cm². 2 The flux reached 65.2 J / cm³ in 30 minutes. 2 Delivery, treatment window is 28.7cm 2 .

3. The apparatus of claim 1, wherein the processor is configured to cause the light source to perform a session of delivering the near infrared light for about 1 to about 120 minutes per day.

4. The apparatus of claim 1, wherein the sexual dysfunction in the subject is a first disease in the subject, wherein the subject has a second disease, and wherein the near infrared light delivered to the subject by the transcranial photobiomodulation is configured to cause a reduction in severity of the sexual dysfunction but not a reduction in severity of the second disease.

5. The apparatus of claim 4, wherein the second disease is depression.

6. The apparatus of claim 1, wherein the near infrared light is configured to treat the sexual dysfunction in a subject who does not have depression.

7. The apparatus of claim 1, wherein the transcranial photobiomodulation is administered bilaterally to the subject, and wherein the transcranial photobiomodulation is administered bilaterally to the forehead of the subject.

8. An apparatus configured to treat sexual dysfunction in a subject, the apparatus comprising: a power source; a light source configured to receive power from the power source causing the light source to emit near infrared light, wherein the near infrared light has a wavelength of about 830 nm; a processor; and a housing configured to house the light source, deliver the near infrared light to an area of interest in the subject, treat the sexual dysfunction by transcranial photobiomodulation of the near infrared light for a sufficient dose and duration, wherein the sexual dysfunction in the subject comprises at least one of impaired sexual desire, impaired sexual arousal, delayed or no orgasm, and 9. The apparatus of claim 8, wherein the near infrared light is delivered for about 1 to about 120 minutes per day.

10. The apparatus of claim 8, wherein the transcranial photobiomodulation is administered bilaterally to the subject, and where the near infrared light is at a wavelength of 830 nm with an average irradiance of 36.2 mW / cm 2 and the fluence reaches 65.2 J / cm 2 delivered, with a therapeutic window of 28.7 cm 2 . wherein the transcranial photobiomodulation is administered bilaterally to the forehead of the subject.

11. The apparatus of claim 8, wherein the near infrared light is configured to treat the sexual dysfunction in a subject who does not have depression. ​ ​

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