Phototherapy system and method for sexual dysfunction

Abstract

Systems and methods for treating sexual dysfunction using transcranial photobiological modulation (t-PBM) of near-infrared light (NIR) are provided. In particular, a device configured to treat a disease in a subject may 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 to 1400 nm. The device has a processor and a housing configured to receive a light source, deliver near-infrared light to a region of interest in a subject, and treat a disease by transcranial photobiological modulation of sufficient dose and duration.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application is based upon and claims the benefit of priority of U.S. patent application serial number 62 / 483,632 filed on April 10, 2017, the entire contents of which are incorporated herein by reference. Background Art

[0003] The present invention generally relates to methods and systems for treating sexual dysfunction, and more particularly, to systems and methods for treating sexual dysfunction by photobiomodulation (t-PBM) with far infrared light (NIR).

[0004] Sexual dysfunction is common, affecting approximately 43% of women and 31% of men in the U.S. Sexual dysfunction may involve decreased libido (sex drive), inadequate arousal - such as incomplete engorgement of the penis or clitoris or lack of vaginal lubrication -, and delayed or absent orgasm (anoorgasm), or a combination thereof.

[0005] The causes of sexual dysfunction vary and include psychological, neurological, endocrine, cardiovascular and cervical conditions, as well as commonly prescribed medications. While any of the above causes may be sufficient to produce sexual dysfunction, more often multiple causes are involved. Consider major depressive disorder (MDD), a common cause of sexual dysfunction with up to 50% of untreated depressed patients experiencing sexual dysfunction. MDD is often associated with other physical conditions, with the prevalence at least twice as high as 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 may have multiple coexisting causes, such as psychological illness, other conditions, and medications, whether the medications are prescribed to treat the same condition or taken for health reasons. The sample of patients with sexual dysfunction described below exemplifies the multifactorial nature of sexual dysfunction.

[0006] There are multiple treatments for sexual dysfunction in women and men; however, patients are increasingly seeking alternative pharmacological and non-pharmacological interventions to treat their disorders, and alternative scientific discoveries that change the current medications used to treat sexual dysfunction are needed.

[0007] It is therefore an object of at least one of the present invention to overcome these drawbacks and problems. Summary of the invention

[0008] The present disclosure overcomes the above-mentioned deficiencies by providing photobiomodulation (PBM) systems and methods with near infrared light (NIR) and including transcranial PBM (t-PBM). Using the systems and methods described herein, mitochondria absorb NIR and increase cellular energy metabolism. According to the present invention, non-limiting benefits of t-PBM include promoting cognition, antidepressant and antianxiety effects. However, the systems and methods provided herein are specifically designed for implementing PBM to treat sexual dysfunction and have been shown to be effective in a group of depressed patients with medical and psychological comorbidities and concomitant medications.

[0009] According to one aspect of the present invention, a device is configured to treat sexual dysfunction in a subject. The device includes 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, wherein the near-infrared light has a wavelength of 600nm-1400nm, and also has a processor. The device also includes a housing configured to accommodate the light source, deliver the near-infrared light to an area of ​​interest of the subject, and treat the sexual dysfunction of the subject through transcranial photobiomodulation of sufficient dose and duration.

[0010] According to another aspect of the present invention, a device configured to treat a disease in a subject is provided. The device 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 600nm-1400nm. The device also includes a processor and a housing configured to accommodate the light source, deliver the near-infrared light to an area of ​​interest of the subject, and treat the disease through transcranial photobiomodulation of sufficient dose and duration.

[0011] In some aspects, the disease is sexual dysfunction. In some aspects, the disease is at least one of impaired libido, impaired sexual arousal, delayed or absent orgasm. The near infrared light can be one of: a wavelength of about 825 nm, a wavelength of about 850 nm, or a wavelength of about 808 nm to about 830 nm. The delivery of near infrared light can last from about 1 minute to about 120 minutes per day. The near infrared light can radiate an average of 36.2 mW / cm at a wavelength of 830 nm. 2 The flux reached 65.2 J / cm in 30 minutes. 2 Delivery, therapeutic window is 28.7cm 2 .

[0012] According to another aspect of the present invention, a method for controlling an apparatus configured to treat a disease in a subject is provided. The method includes: providing power to an apparatus having a light source so that the light source emits near infrared light to an area of ​​interest in the subject, the near infrared light having a wavelength of 600 nm to 1400 nm. The method also includes delivering the near infrared light to the area of ​​interest in the subject via transcranial photobiomodulation, the dose and duration of which is sufficient to treat the disease.

[0013] In some aspects, the disease is sexual dysfunction. In some aspects, the disease is at least one of impaired libido, impaired sexual arousal, delayed or absent orgasm. The near infrared light can be one of: a wavelength of about 825 nm, a wavelength of about 850 nm, or a wavelength of about 808 nm to about 830 nm. The delivery of near infrared light can last from about 1 minute to about 120 minutes per day. The near infrared light can radiate an average of 36.2 mW / cm at a wavelength of 830 nm. 2 and the flux reached 65.2 J / cm in 30 minutes 2 Delivery, therapeutic window is 28.7cm 2 . BRIEF DESCRIPTION OF THE DRAWINGS

[0014] Other objects, features and advantages of the present invention will become more apparent from the following detailed description and the accompanying drawings showing illustrative embodiments, in which:

[0015] Figure 1 is a schematic diagram depicting a transcranial photobiomodulation device according to the present specification.

[0016] Figure 2 is a flow chart that provides Figure 1 Examples of non-limiting steps of a method of systemic transcranial photobiomodulation.

[0017] Figure 3 is the total SAFTEE sexuality score showing the effect of t-PBM on sexual dysfunction in the entire sample over time.

[0018] Figure 4 is the total SAFTEE sexual score showing the effect of t-PBM on sexual dysfunction for all completers over time.

[0019] Figure 5 is the total SAFTEE sex score sheet before and after treatment.

[0020] Figure 6 is the total SAFTEE sexuality rating form for all women and all men before and after treatment.

[0021] Figure 7 It is a score sheet for impaired sexual desire, impaired sexual arousal, and impaired orgasm before and after treatment for all samples.

[0022] Figure 8 It is a pre- and post-treatment rating scale for impaired sexual desire, impaired sexual arousal, and impaired orgasm in completers.

[0023] The following detailed description of the invention, given by way of example and not intended to limit the invention solely to the particular embodiments described, may be read in conjunction with the accompanying drawings, which are incorporated herein by reference. DETAILED DESCRIPTION

[0024] As used herein, the terms "treat", "treat", and the like refer to reducing or alleviating a disease, such as sexual dysfunction and / or a brain disease and / or its associated symptoms. It should be understood that, although not exclusive, treatment of a brain disorder does not require complete elimination of the disorder, condition, or its associated symptoms.

[0025] Unless otherwise specified or clearly indicated from the context, the term "about" as used herein should be understood as the range normally allowed in the art, such as within 2 standard deviations of the average. "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 indicated value. Unless otherwise expressly indicated herein, all numerical values ​​provided herein are modified by the term about.

[0026] The term "effective" as used herein means sufficient to achieve a desired, expected or intended result. When used to treat a subject or patient with a compound, an "effective amount," "therapeutically effective amount," or "pharmaceutically effective amount" refers to an amount of a compound that is sufficient to be effective in treating a disease when administered to a subject or patient.

[0027] As used herein, the term "transcranial photobiomodulation" refers to the use of several treatment techniques that use infrared, low-level laser, and / or LED light to treat disease across or through the skull.

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

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

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

[0031] In general, the controller 120 is programmed or otherwise configured to perform the methods and algorithms described below. For example, the controller 120 is programmed to provide power to the light source 102 through the power supply 101 according to any dose, duration or pulse sequence described herein to emit near infrared light. In a non-limiting example, LED and laser devices can be used. In addition or alternatively, wavelengths of 600-1400nm can be used. A given dose can be delivered with continuous and / or pulsed light CW or PW1-300Hz (roughly 10Hz, 20Hz, 30Hz, 40Hz). The average radiation can be, for example, 10-750mW / cm 2 The average flux can be, for example, 10-160 J / cm 2 As another example, the duration of treatment may be 1-120 minutes per day.

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

[0033] The memory 106 may include 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 the one or more hardware processors 104. In some aspects, the software 110 may include instructions for emitting near infrared light as desired at various organs and / or systems within the head or other parts of a subject.

[0034] Figure 2 An exemplary method of the specification is shown. The method may include a step 200 of placing a light source, such as light source 102, to deliver near infrared light to an area of ​​interest, such as area of ​​interest 132 of subject 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 for treating the subject. Device 100 may have the above-mentioned light source 102, and the power supplied to device 100 may be sufficient to cause light source 102 to emit near infrared light to area of ​​interest 132 of subject 130. A non-limiting example of a therapeutically effective amount may be about 0.1-5 kJ each time or about 2.4 kJ or 3.4 kJ each time. Each treatment may be weekly, daily, or several times a day, such as twice a day or varying during the period. Step 202 of the method may be to deliver near infrared light to area of ​​interest 132 of the subject by transcranial photobiomodulation, and the dose and duration thereof are sufficient to treat the disease.

[0035] In some configurations, the near infrared light may have a wavelength of 600nm-1400nm. More specifically, configuring or controlling the device may include generating near infrared light at a wavelength of about 825nm, a wavelength of about 850nm, or a wavelength of about 808nm to about 830nm. In addition, configuring or controlling may include causing a processor of the device to control the light source to perform a period of about 1-120 minutes of delivery of near infrared light per day. In one non-limiting example, the device may be configured and / or controlled to deliver near infrared light of 830nm wavelength with an average radiation of 36.2mW / cm 2 , the flux reached 65.2J / cm in 30 minutes 2 , the treatment window is 28.7cm 2 Thus, a therapeutically effective amount is effective to treat sexual dysfunction, which may include at least one of impaired sexual desire, impaired sexual arousal, and delayed or absent orgasm.

[0036] The following provides information regarding a study that performed and demonstrates a non-limiting example of the present description.

[0037] Methods and Materials

[0038] Inclusion and Exclusion Criteria

[0039] Adult subjects (18-65 years old) who meet the criteria for MDD of the Structured Clinical Reporting Disorders (SCID) of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) and have a depression severity rated as at least moderate (Hamilton Depression Rating Scale, HAM-D17 total score of 14-24) are included in the study after providing written informed consent. At this stage, the subjects may have failed no more than one FDA-approved antidepressant treatment (at least 6 weeks) and no more than one period of structured psychotherapy for depression (at least 8 weeks). Other exclusion criteria include spontaneous substance abuse disorder (previous 6 months), lifetime psychotic episodes, bipolar disorder, suicidal ideation and homicidal ideation, as well as unstable conditions and recent stroke (previous 3 months). Women of pregnancy potential, such as those who are sexually active, need to use contraceptive measures, and pregnant or breastfeeding women are excluded. In order to achieve maximum light penetration and minimize the risk of local tissue damage using NIR, the following conditions need to be excluded: 1. Having forehead skin conditions; 2. Taking light-activated drugs (previous 14 days); 3. Having head implants.

[0040] Study Design and Procedures:

[0041] Subjects who met the criteria were randomized into an 8-week study group, with double-blind NIR t-PBM versus sham treatment twice a week (16 sessions total). NIR or sham treatment was applied to both sides of the forehead during each treatment, targeting the F3 and F4 areas of the dorsolateral prefrontal cortex (dlPFC) (based on EEG localization maps). The clinical staff of the study had the discretion to adjust the duration of light exposure at the 4th and 6th weeks (after completing 6 or 10 sessions each), from 20 minutes to 25 and 30 minutes, respectively, based on tolerance and effectiveness. The research device used an LED light source emitting NIR at a wavelength of 830nm for each of the two devices, with an average radiation of 36.2mW / cm 2 , the flux reached 65.2J / cm in 30 minutes 2 Delivery, therapeutic window is 28.7cm 2 All but three subjects remained on stable antidepressant treatment during the study; their data were excluded after they switched to concomitant antidepressant treatment.

[0042] Randomization and blind selection

[0043] There were two t-PBM device types for each mode (NIR and sham treatment). The appearance of the device (i.e., all visible and audible indicators) was the same in both modes. However, only the t-PBM device in the NIR mode produced therapeutic NIR energy. NIR light is invisible and therefore cannot be detected by patients or doctors. Research assistants randomized subjects 1:1 for each pair of instruments for "A" and "B" using permuted module randomization, as well as different module sizes. Only research assistants were able to identify each pair of instruments as "A" and "B." Investigators and subjects remained blinded to the assignment of the subjects because the labels on each device were covered before treatment. The blind selection numbers for NIR and sham treatment were placed in sealed envelopes at the study site for each marked pair of devices. Blinding had been tested in ELATED-2 before the second report, and there was no significant association between treatment assignment and subjects' guesses about the treatment they had received.

[0044] Clinical outcome measures

[0045] The outcome measure for this secondary analysis of ELATED-2 was overall sexual dysfunction, assessed weekly, using the Systematic Assessment of Treatment-Emergence Effects-Specific Investigation (SAFTEE-SI) ratings (Levine and Schooler 1992). A list of fifty-five (55) adverse symptoms that are usually or likely to be experienced during treatment is ranked by severity as zero (0) - none; one (1) - mild; two (2) - moderate, and three (3) - severe. For the SAFTEE rating, three items were defined as being related to sexual dysfunction: Item 36 - loss of sexual interest, Item 37 - problems with sexual arousal (erection or lubrication), and Item 38 - delayed or absent orgasm. 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 representing increasing or worsening dysfunction. No conclusions were drawn as to whether sexual dysfunction was influenced by the experience of major depressive illness, concomitant medications, comorbid illnesses or conditions, or other factors, including study participants and t-PBM. The instructions for self-rating are virtually universal: "Below is a list of symptoms that people sometimes experience. Please read each item; indicate how much each symptom bothers you by circling the appropriate number to the right of the item."

[0046] Study samples and data cleaning

[0047] Twenty-one (21) randomized subjects who received at least one t-PBM were included in the original ELATED-2 sample. However, for this secondary analysis - repeated measures of self-assessment - the sample was limited to 20 subjects because one subject in the original database consistently skipped answers on several rating forms during the study. The subject had a diagnosis of an attention deficit condition and reported significant difficulty focusing in the absence of stimuli. Briefly, three subjects were excluded as part of an a-priori data cleanup process due to starting new psychiatric treatment during the study. All other available data were included, regardless of withdrawal.

[0048] analyze:

[0049] Descriptive statistics were used to describe the odds of conditions and treatments commonly associated with sexual dysfunction. Unpaired Mann-Whitney (two-tailed) and Pearson chi-square tests compared baseline characteristics of the NIR and sham treatment groups for continuous and nominal variables, respectively. The Mann-WhitneyU test (two-tailed) was also selected to compare the changes in the total severity score of sexual dysfunction (total SAFTEE sexual score) from baseline to endpoint (the last assessment performed) between the two study groups. The same analysis was repeated in the following subsamples: in completers, all women, and all men. For specific types of sexual dysfunction such as impaired sexual desire, sexual arousal, and orgasm, the changes in severity scores for each of the three SAFTEE items (36, 37, and 38) were compared in the entire sample and completers (Mann-WhitneyU test, two-tailed). The small sample size resulted in the use of nonparametric tests that did not cover changes in depression severity. As a post hoc analysis, in order to better focus on whether the antidepressant effect would drive the effect on sexual function, t-PBM made changes in the severity of sexual dysfunction and for depression severity (HAM-D 17 Cohen's d effect was calculated for changes in the total score. Then, the timing of significant changes in sexual dysfunction and depression severity was assessed, because the plotting of the means showed early improvements in sexual function (the last assessment was performed at a specific time point, using the Mann-Whitney U test, two-tailed, for changes from baseline). The initial outcome, overall change in sexual dysfunction, was repeated after removing the two subjects who were not assessed after baseline (n=18, Mann-Whitney U test, two-tailed). For all analyses, significance was set at p≤0.05.

[0050] result

[0051] Causes of sexual dysfunction and baseline characteristics

[0052] According to the adopted criteria, all subjects (n=20) had major depressive disorder, a common cause of sexual dysfunction. It should be noted that 45% and 25% of the subjects in the same group were diagnosed with at least one or two other psychiatric disorders, respectively; the most common classifications were anxiety disorders, post-traumatic stress disorder, and social anxiety disorder. Non-psychiatric medical conditions affected almost all subjects (about 85% of the subjects), many of which may be associated with sexual dysfunction. Endocrine conditions were also the most common (30%), including thyroid and associated thyroid diseases, as well as thyroid hormone supplementation. Neurological conditions were also quite common (30%), including concussion, spinal injury, and a history of 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 subjects (80%) received medication. Some non-limiting examples of prescription medications for which sexual dysfunction was noted as a possible side effect include antidepressants or other psychotropics taken by 45% of the subjects, anti-epileptic medications taken by 15%; alpha2-agonists, diuretics, statins, or calcium channel blockers also taken by 15%. Non-limiting examples of medications or other drugs for which sexual dysfunction could be a possible side effect include narcotics and NSAIS taken by one patient; and women of childbearing age who were required to take oral contraceptives (or use other forms of birth control) for study participation. See Table 1 for medical conditions and treatments that commonly affect sexual function and their prevalence in our study sample. Overall, 90% of the study subjects had at least one additional explanation for their sexual dysfunction - in addition to depression or other psychiatric diagnosis.

[0053]

[0054] There were no significant differences between the two groups at baseline for demographic and clinical characteristics, and concomitant antidepressant treatment, as described in more detail in the Examples below. During the study, all subjects continued their baseline antidepressant treatment (if present), except for one subject 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 Global Severity Rating Scale.

[0058] Overall sexual dysfunction

[0059] The mean change in total SAFTEE sex score was significantly greater in subjects receiving t-PBM in the NIR mode than in those receiving the sham mode in both the entire sample [NIR (n=9) -2.55±1.88 vs. sham (n=11) -0.45±1.21; z=2.548, p=.011)] and in completers [NIR (n=5) -3.4±1.95 vs. sham (n=7) -0.14±1.21; z=2.576, p=.010)]. Figure 3 and 4 The mean total SAFTEE sexuality scores within the two t-PBM groups (NIR and sham) as the study progressed are shown in the full sample and completers. After removing two subjects from the analysis due to lack of post-treatment assessment, the finding was confirmed [NIR (n = 9) -2.55 ± 1.88 vs. sham (n = 9) -0.55 ± 1.33; z = 2.215, p = .027)]. When the full sample was divided based on sex, the same comparison also reached significance in females [NIR (n = 5) -3.0 ± 2.24 vs. sham (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 (n = 5) -0.6 ± 1.67; z = 1.014, p = .310)], see Figure 5 and 6 .

[0060] The improvement effect in total sexual function was d = 1.33 (n = 20) and d = 1.23 (n = 18) (Cohen's d test). These effects were 55% and 73% higher than those observed for the reduction in depression severity [d = 0.86 (n = 20) and d = 0.71 (n = 18)]. A significant reduction in total sexual dysfunction was already recorded at the end of week 2 in the entire sample, but not in depression severity [NIR (n = 9) -1.11 ± 1.17 vs. Sham (n = 11) -0.09 ± 1.05; z = 1.972, p = .049)]. After the end of Week 3, two subjects were removed due to lack of post-treatment assessment, but a significant reduction in total sexual dysfunction but not depression severity was recorded [NIR (n = 9) -2.11 ± 1.45 vs. Sham (n = 9) -0.44 ± 1.24; z = 2.313, p = .021). The reduction in depression severity was not significant at any time point in either sample (n = 20 and n = 18; it should be noted that both samples were smaller than the original ELATED-2 sample n = 21 as previously reported).

[0061] Impaired sexual desire

[0062] Comparison of mean changes in SAFTEE Item 36 score “Loss of Sexual Interest” was significant in the full sample [NIR (n = 9) -1.2 ± 1.09 vs. Sham (n = 11) -0.4 ± 0.67; z = 1.930, p = .054)] and in completers [NIR (n = 5) -1.8 ± 1.09 vs. Sham (n = 7) -0.3 ± 0.49; z = 2.276, p = .023)]. The percentage decrease in the severity of “Loss of Sexual Interest” in the t-PBM NIR group was -79% and -90% in the full sample and completers, respectively, see Table 2. Figure 7 and 8 .

[0063] Impaired sexual arousal

[0064] Comparison of mean changes in SAFTEE Item 37 score "Problems related to sexual arousal (erection or lubrication)" reached significance in the full sample [NIR (n = 9) -0.8 ± 0.67 vs. Sham (n = 11) -0.1 ± 0.30; z = 2.633, p < .001)] but not in completers [NIR (n = 5) -0.8 ± 0.84 vs. Sham (n = 7) -0.1 ± 0.38; z = 1.659, p = .097)]. The percentage decrease in severity of "Problems related to sexual arousal" in the t-PBM NIR group was -78% and -80% in the full sample and completers, respectively.

[0065] Delayed or no orgasm

[0066] Comparison of mean changes in SAFTEE Item 38 "Delayed or absent orgasm" reached significance in completers [NIR (n=09) -0.6±0.73 vs. Sham (n=11) 0.0±0.89; z=1.738, p=.08); NIR (n=5) -0.8±0.84 vs. Sham (n=7) -0.3±0.76; z=2.228, p=.026)]. The percent decrease in severity of "delayed and absent orgasm" in the t-PBM NIR group was -72% and -80% in the entire sample and completers, respectively.

[0067] discuss

[0068] Studies on the effects of t-PBM on sexual dysfunction have shown significant therapeutic effects, including a reversal effect in patients with multi-cause sexual dysfunction.

[0069] Three subjects reported improvements in sexual function that were unusual in magnitude and rapidity. These three clinical cases (briefly reported below) led to the present exploratory analysis of the putative effects of t-PBM on sexual function in the entire sample. We relied on the use of a composite score (total SAFTEE sexual score) to describe sexual impairment. The SAFTEE score had been included in the protocol to account for possible new onset side effects associated with t-PBM; in this case, we used the SAFTEE score to track changes over time in sexual function, which was impaired on average in this group of MDD patients.

[0070] The unexpected improvement in sexual function with t-PBM in the depressed subject group was also documented in both the full sample and the completer sample. This finding remained significant for the female subgroup, but was not significant 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 genders and was slightly higher in men (women - 75% and men - 80%) when receiving t-PBM. It is prudent to assume that the lack of a statistically significant finding in men and the relationship between lack of energy are warranted.

[0071] Aspects of sexual dysfunction were tested to elucidate factors most likely driving the overall findings. In the full sample, sexual arousal was most significantly improved with t-PBM relative to sham, whereas improvements in desire and orgasm were most significant with t-PBM in completers, but not for arousal. Surprisingly, similar reductions in sexual dysfunction severity were found across the board when investigating the magnitude of improvement in each sexual dimension. Therefore, the lack of statistical significance for some comparisons may be interpreted as a lack of energy; in fact, each dimension of sexual dysfunction may be less sensitive due to the four-point Likert scale (scores 0-3). The magnitude of reduction in each dimension of sexual dysfunction appeared to be slightly higher in completers (impaired desire - 90%; impaired arousal and impaired orgasm - 80%) compared to the full sample (impaired desire - 79%; impaired arousal - 78% and impaired orgasm - 72%). Completers may have benefited from a greater number of sessions and longer exposure to t-PBM, as exposure increased by 20-30 minutes over the course of the study.

[0072] The nature or cause of the sexual dysfunction in our group was multifactorial; although underlying depressive symptoms were common to all patients, there may also be a variety of other possible factors, such as comorbid conditions and medications. The antidepressant effect of t-PBM in the same group was previously demonstrated - the effect of t-PBM on sexual dysfunction was relative to its effect on depression. In this study, the effects of t-PBM on sexual dysfunction were more rapid and greater than those on depression, which is contrary to the conclusion that any improvement in sexual function was due to amelioration of the depressive syndrome. Instead, t-PBM is more likely to have a beneficial effect on sexual function independent of the consequences of depression.

[0073] t-PBM affects sexual function in several ways. At least two non-limiting hypotheses for the mechanisms of t-PBM effects on sexual function can be followed. First, direct neuromodulation mediates the effects in the central nervous system, more specifically the target prefrontal cortex (i.e., enhanced EEG activity). Second, an increase in signaling molecules mediates the effects, such as neuronal nitric oxide (NO). Not only does tPBM increase NO through NIR, it is also speculated that neuronal, intracellular, and extracellular NO in the hypothalamus are necessary for the onset of puberty and fertility, and regulate GnRH and LH release.

[0074] Clinical observations drove at least part of this study, thus testing and reporting hypotheses. During the clinical trial, neither the investigators nor the subjects expected an 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 studies from the research group.

[0077] Example 1

[0078] 65-year-old divorced, retired male, father of two adult children. At the time of the study, he was in a relationship but lived separately. At baseline, he rated his loss of sexual interest as “severe” and his arousal (erection) problems as “moderate.” After two t-PBM sessions (one week), the patient reported only a “mild” loss of sexual interest and “mild” arousal problems. Although his weekly sexual function ratings fluctuated, after completing 15 t-PBM sessions, the patient continued to report having erectile dysfunction and only minimal decreases in sexual interest. At the study 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 spend the night there.

[0079] Example 2

[0080] 44-year-old married woman; professional and mother of two young children. She had been taking venlafaxine 75 mg daily for 6 weeks prior to study entry and continued to take the medication during the study. Although she had not experienced significant impairment in her sexual function prior to starting her antidepressant medication (despite being depressed), she subsequently complained of decreased libido and loss of sexual pleasure due to venlafaxine. Before starting her t-PBM program, she rated her loss of sexual interest as “severe,” her problems with arousal as “mild,” and her delayed or absent orgasms as “moderate.” After the first two sessions (1 week), her loss of sexual interest was rated as “mild,” her lubrication problems resolved, and her delayed or absent orgasms as “mild.” After 10 tPBM sessions, her sexual dysfunction resolved completely. At the end of the study, the patient was concerned that t-PBM was not a routine intervention and viewed her sexual function as equivalent to her adolescence.

[0081] Example 3

[0082] 27-year-old single male in a relationship. At baseline, he reported "mild" loss of sexual interest and problems with arousal (erection). At week 1, his interest and desire were normal, and at week 2, only loss of sexual interest was present, rated as "mild". During the study (week 1), the patient reported that his sexual interest and behavior nearly doubled: he went from having sex 4-5 times per week to 8-9 times per week. After 4 t-PBMs (2 weeks), the patient stopped coming to the study for follow-up and eventually withdrew from the study.

[0083] The foregoing is merely illustrative of the principles of the present invention. A person skilled in the art will understand various changes and variations of the described embodiments after reading the contents of this article. It should therefore be understood that a person skilled in the art can design various systems, arrangements, and methods, which, although not expressly described or shown herein, all embody the principles of the present invention and are included in the concept and scope of the present invention. In addition, the prior art, unless specifically incorporated herein by reference, is also incorporated herein in its entirety for reference. All publications cited above are incorporated herein by reference in their entirety.

Claims

1. A device configured to treat sexual dysfunction in a subject, the device comprising: power supply; a light source configured to receive power from a power source to cause the light source to emit near infrared light; processor; and a housing configured to house a light source to deliver near infrared light to an area of ​​interest of a subject to treat sexual dysfunction in the subject via transcranial photobiomodulation of near infrared light at a sufficient dose and duration, The sexual dysfunction includes at least one of impaired sexual desire, impaired sexual arousal, delayed or absent orgasm, and The near-infrared light with a wavelength of 830nm has an average radiation of 36.2mW / cm 2 and the flux reached 65.2 J / cm in 30 minutes 2 Delivery, therapeutic window is 28.7cm 2 .

2. The apparatus of claim 1, wherein the subject suffers from depression, and wherein the near infrared light delivered to the subject is configured to treat the subject's sexual dysfunction in a manner independent of treating the subject's depression.

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

4. A method of controlling a device for treating sexual dysfunction in a subject, the method comprising: providing power to a device having a light source so that the light source emits near infrared light to an area of ​​interest of the subject, and delivering near infrared light to an area of ​​interest in a subject via transcranial photobiomodulation, the near infrared light being of a dose and duration sufficient to treat the sexual dysfunction, and The sexual dysfunction includes at least one of impaired sexual desire, impaired sexual arousal, delayed or absent orgasm, and The near-infrared light with a wavelength of 830nm has an average radiation of 36.2mW / cm 2 and the flux reached 65.2 J / cm in 30 minutes 2 Delivery, therapeutic window is 28.7cm 2 .

5. The method of claim 4, wherein the near infrared light delivery lasts from about 1 to about 120 minutes per day.

6. A device configured to treat sexual dysfunction in a subject, the device comprising: power supply; a light source configured to receive power from a power source to cause the light source to emit near infrared light, wherein the near infrared light has a wavelength of about 830 nm; processor; and A housing configured to house a light source for delivering near infrared light to an area of ​​interest of a subject to treat sexual dysfunction via transcranial photobiomodulation of near infrared light of sufficient dose and duration, wherein the subject's sexual dysfunction includes at least one of impaired sexual desire, impaired sexual arousal, delayed or absent orgasm, and The near-infrared light with a wavelength of 830nm has an average radiation of 36.2mW / cm 2 and the flux reached 65.2 J / cm in 30 minutes 2 Delivery, therapeutic window is 28.7cm 2 .

7. The device of claim 6, wherein the near infrared light delivery lasts from about 1 to about 120 minutes per day.

8. The apparatus of claim 1, wherein the subject's sexual dysfunction is the subject's first disease, wherein the subject suffers from a second disease, and Wherein the near infrared light delivered to the subject via transcranial photobiomodulation is configured to result in a reduction in severity of the sexual dysfunction but not in a reduction in severity of the secondary condition.

9. The apparatus of claim 8, wherein the second disease is depression.

10. The apparatus of claim 6, wherein transcranial photobiomodulation is applied bilaterally to the subject, and Wherein transcranial photobiomodulation was applied bilaterally to the subject's forehead.

11. The method of claim 4, wherein the subject suffers from depression, and Wherein the near infrared light delivered to the subject via transcranial photobiomodulation is configured to treat sexual dysfunction in a manner independent of the subject's depression.

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

13. The method of claim 4, wherein the subject does not suffer from depression.

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

15. The apparatus of claim 1, wherein transcranial photobiomodulation is administered bilaterally to the subject, and Transcranial photobiomodulation was applied bilaterally to the subject's forehead.

16. The apparatus of claim 4, wherein transcranial photobiomodulation is applied bilaterally to the subject, and wherein transcranial photobiomodulation is applied bilaterally to the forehead of the subject.

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