Trial Summary
What is the purpose of this trial?This trial is testing a special kind of invisible light aimed at the forehead to help people with depression. The light might improve blood flow in the brain. About 60 people with depression will be part of this study to see if this treatment works.
Is Transcranial Photobiomodulation a promising treatment for depression?Transcranial Photobiomodulation (tPBM) is a promising treatment for depression because it is safe, non-invasive, and has shown effectiveness in reducing depressive symptoms. It uses light to stimulate brain activity, which can help improve mood. Some studies have found it effective in decreasing depression severity, suggesting it could be a valuable option for treating depression.12567
What safety data is available for transcranial photobiomodulation treatment?The safety data for transcranial photobiomodulation (t-PBM) indicates that it is generally well-tolerated with no serious adverse events reported. A study on repeated sessions of t-PBM found that more subjects experienced side effects compared to sham, but these were not statistically significant and were mostly mild, resolving during the study without requiring treatment interruption. Changes in weight and blood pressure were not significant, although a slight increase in diastolic blood pressure was noted. Overall, the treatment appears to have a benign safety profile, but larger studies are needed to confirm these findings.34567
Do I have to stop taking my current medications for the trial?The trial requires that participants taking medications for major depressive disorder be stable on them for at least 8 weeks before screening. If you are taking medications other than SSRIs, SNRIs, or Wellbutrin (bupropion) for depression, you may need to stop them. The protocol does not specify a washout period for these medications.
What data supports the idea that Transcranial Photobiomodulation for Depression is an effective treatment?The available research shows that Transcranial Photobiomodulation (tPBM) might help reduce symptoms of depression. A meta-analysis, which combines results from different studies, found that tPBM was effective in decreasing depression severity. However, when comparing tPBM to a fake treatment (sham), the results were not significantly better, suggesting more research is needed. Overall, while there is some promise, the evidence is not strong enough yet to confirm its effectiveness.12567
Eligibility Criteria
Adults aged 18-65 with Major Depressive Disorder, stable on current medications or psychotherapy for at least 8 weeks, and not in immediate crisis. They must score ≥23 on the IDS-C for depression severity and be able to consent to study procedures. Excludes those with certain psychiatric disorders, substance abuse issues, significant medical conditions, or using specific depression treatments.Inclusion Criteria
I am between 18 and 65 years old.
I am between 18 and 65 years old.
I am between 18 and 65 years old.
I have been diagnosed with major depressive disorder with significant symptoms.
Exclusion Criteria
I am not at immediate risk of harming myself or others.
I have not had dementia, significant brain injuries, strokes, or seizures needing treatment in the last 5 years.
I am using a device or taking non-SSRI/SNRI/Wellbutrin medication for depression.
I have depression and haven't improved after trying two different antidepressants.
My health is stable and I don't have uncontrolled serious illnesses.
I have skin conditions like rashes or wounds on my scalp where the procedure will be.
I cannot have an MRI due to safety concerns like claustrophobia or metal in my body.
Treatment Details
The trial is testing if near infrared energy applied to the forehead can alter brain blood flow in depressed individuals. Participants will either receive the actual Transcranial Photobiomodulator treatment or a sham (placebo) procedure to compare effects.
2Treatment groups
Experimental Treatment
Active Control
Group I: tPBM GroupExperimental Treatment2 Interventions
Visit 1: t-PBM at irradiance dose of 291.7 mW/cm2 (333s) Visit 2 - 18: randomized to receive active t-PBM of 291.7 mW/cm2 (333s) Visit 19: t-PBM at irradiance dose of 291.7 mW/cm2 (333s)
Group II: Sham GroupActive Control2 Interventions
Visit 1: t-PBM at irradiance does of 291.7 mW/cm2 (333s) Visit 2 - 18: randomized to receive Sham of 0 mW/cm2 (333s) Visit 19: t-PBM at irradiance dose of 291.7 mW/cm2 (333s)
Transcranial Photobiomodulator is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Transcranial Photobiomodulation Therapy for:
- Depression (investigational)
- Traumatic Brain Injury (investigational)
- Stroke (investigational)
- Breast Cancer Related Lymphedema (investigational)
🇪🇺 Approved in European Union as Transcranial Photobiomodulation Therapy for:
- No specific approvals listed; various investigational uses
Find a clinic near you
Research locations nearbySelect from list below to view details:
Nathan Kline Institute for Psychiatric ResearchOrangeburg, NY
Harvard Medical SchoolBoston, MA
NYU Langone HealthNew York, NY
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Who is running the clinical trial?
NYU Langone HealthLead Sponsor
National Institutes of Health (NIH)Collaborator
References
Effects of transcranial photobiomodulation with near-infrared light on sexual dysfunction. [2020]Transcranial photobiomodulation (t-PBM) consists of the delivery of near-infrared (NIR) or red light to the scalp designed to penetrate to subjacent cortical areas of the brain. NIR t-PBM has recently emerged as a potential therapy for brain disorders. This study assessed the efficacy of repeated sessions of NIR t-PBM on sexual dysfunction.
Transcranial and systemic photobiomodulation for major depressive disorder: A systematic review of efficacy, tolerability and biological mechanisms. [2019]Photobiomodulation (PBM) with red and near-infrared light (NIR) -also known as Low-Level Light Therapy-is a low risk, inexpensive treatment-based on non-retinal exposure-under study for several neuropsychiatric conditions. The aim of this paper is to discuss the proposed mechanism of action and to perform a systematic review of pre-clinical and clinical studies on PBM for major depressive disorder (MDD).
Transcranial Photobiomodulation for the Treatment of Major Depressive Disorder. The ELATED-2 Pilot Trial. [2021]Objective: Our objective was to test the antidepressant effect of transcranial photobiomodulation (t-PBM) with near-infrared (NIR) light in subjects suffering from major depressive disorder (MDD). Background: t-PBM with NIR light is a new treatment for MDD. NIR light is absorbed by mitochondria; it boosts cerebral metabolism, promotes neuroplasticity, and modulates endogenous opioids, while decreasing inflammation and oxidative stress. Materials and methods: We conducted a double-blind, sham-controlled study on the safety and efficacy [change in Hamilton Depression Rating Scale (HAM-D17) total score at end-point] of adjunct t-PBM NIR [823 nm; continuous wave (CW); 28.7 × 2 cm2; 36.2 mW/cm2; up to 65.2 J/cm2; 20-30 min/session], delivered to dorsolateral prefrontal cortex, bilaterally and simultaneously, twice a week, for 8 weeks, in subjects with MDD. Baseline observation carried forward (BOCF), last observation carried forward (LOCF), and completers analyses were performed. Results: The effect size for the antidepressant effect of t-PBM, based on change in HAM-D17 total score at end-point, was 0.90, 0.75, and 1.5 (Cohen's d), respectively for BOCF (n = 21), LOCF (n = 19), and completers (n = 13). Further, t-PBM was fairly well tolerated, with no serious adverse events. Conclusions: t-PBM with NIR light demonstrated antidepressant properties with a medium to large effect size in patients with MDD. Replication is warranted, especially in consideration of the small sample size.
Reported Side Effects, Weight and Blood Pressure, After Repeated Sessions of Transcranial Photobiomodulation. [2020]Background: Transcranial photobiomodulation (t-PBM) consists in the delivery of near-infrared light (NIR) to the scalp, directed to cortical areas of the brain. NIR t-PBM recently emerged as a potential therapy for depression, although safety of repeated treatments has not been adequately explored. Objective: This study assessed incidence of side effects, including weight and blood pressure changes, during repeated sessions of NIR t-PBM using a light-emitting diode source. Methods: We performed a secondary analysis of a double-blind clinical trial on t-PBM for major depressive disorder. Eighteen individuals received NIR t-PBM (n = 9) or sham (n = 9) twice weekly for 8 weeks. Side effects were assessed using the Systematic Assessment for Treatment-Emergent Effects-Specific Inquiry. In 14 individuals (nNIR = 6 vs. nsham = 8), body weight and systemic blood pressure were recorded at baseline and end-point. Results: More subjects in the NIR t-PBM group experienced side effects compared to sham, but only a trend for statistical significance was observed (χ2 = 3.60; df = 1; p = 0.058). The rate of side effects described by participants as "severe" in intensity was low and similar between the treatment groups (χ2 = 0.4; df = 1; p = 0.53), with no serious adverse events. Most side effects resolved during the study and treatment interruption were not required. Changes in weight and systolic blood pressure across groups were neither significant nor approached significance. In the NIR t-PBM group, diastolic blood pressure increased and reached statistical-however not clinical-significance (5.67 ± 7.26 vs. -6.13 ± 6.88; z = -2.40, p = 0.016). Conclusions: This small-sample, exploratory study indicates repeated sessions of NIR t-PBM might be associated with treatment-emergent side effects. The systemic metabolic and hemodynamic profile of repeated t-PBM appeared benign. Future studies with larger samples and longer follow-up are needed to more accurately determine the side-effect profile and safety of NIR t-PBM.
Very Low-Level Transcranial Photobiomodulation for Major Depressive Disorder: The ELATED-3 Multicenter, Randomized, Sham-Controlled Trial. [2022]Background: Transcranial photobiomodulation (t-PBM) with near-infrared (NIR) light might represent a treatment for major depressive disorder (MDD). However, the dosimetry of administered t-PBM varies widely. We tested the efficacy of t-PBM with low irradiance, low energy per session, and low number of sessions in individuals with MDD.
Efficacy of Transcranial Photobiomodulation on Depressive Symptoms: A Meta-Analysis. [2023]Background: Transcranial photobiomodulation (tPBM) is a novel, noninvasive, device-based intervention, which has been tested as a possible treatment for various neurological and psychiatric conditions. Recently, it has been investigated as an innovative treatment for major depressive disorder (MDD). There have been several animal and clinical studies that evaluated the underlying mechanism and the efficacy of its antidepressant effects, but results have been conflicting. Objective: Thus, we conducted the first meta-analysis on effects of tPBM on depressive symptoms. Materials and methods: Thirty original articles on tPBM were retrieved, eight of them met criteria for inclusion to a random effects meta-analysis. Results: tPBM appeared effective in decreasing depressive symptom severity regardless of diagnosis (Hedges' g = 1.415, p < 0.001, k = 8), but a significant heterogeneity has been found. The meta-analysis of single-arm studies (baseline to endpoint changes) limited to participants with MDD has supported the significant effect of tPBM in reducing the depression severity, without a significant heterogeneity (Hedges' g = 1.142, 95% confidence interval = 0.780-1.504, z = 6.19, p < 0.001, k = 5). However, the meta-analysis of the few double-blind, sham-controlled studies in MDD has not supported the statistically significant superiority of tPBM over sham (Hedges' g = 0.499, p = 0.211, k = 3), although a sample size bias is likely present. Conclusions: Overall, this meta-analysis provides weak support for the promising role of tPBM in the treatment of depressive symptoms. Dose finding studies to determine optimal tPBM parameters followed by larger, randomized, sham-controlled studies will be needed to fully demonstrate the antidepressant efficacy of tPBM.
Effect of transcranial photobiomodulation on electrophysiological activity of brain in healthy individuals: A scoping review. [2023]Transcranial photobiomodulation (tPBM) is a safe and non-invasive treatment that has recently emerged as an effective technique to apply near-infrared or red light to activate neural tissues. The objective is to review the literature on the effect of tPBM on electrophysiological activity in healthy individuals.