Major Depressive DisorderTRIADENCT04366258

Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression

A study testing Transcranial Photobiomodulator in people with Major Depressive Disorder, run by NYU Langone Health at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Major Depressive Disorder
What is being tested?: Transcranial Photobiomodulator
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 55 participants
Where: 3 sitesUnited States
Study dates: 1 Aug 2020to 24 Jun 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants must be able to give written informed consent and follow study procedures
Participants must have major depressive disorder; all the following conditions need to be met to ensure presence of significant depression symptoms:
Meeting diagnostic criteria for Major Depressive Disorder (MDD) in the past two weeks, at the DSM-5 Mini-International Neuropsychiatric Interview (MINI)
Inventory for Depressive Symptomatology Clinician-rated (IDS-C) total score ≥23 at screening
Depression symptoms are the primary target of treatment or treatment-seeking.
Women of child-bearing potential must agree to use adequate contraception
Participants taking medications or psychotherapy approved for the treatment of major depressive disorder will need to be stable for at least 8 weeks prior to screen

Who cannot join

Unwilling or unable to comply with study requirements
Participants who are judged to be at serious and imminent suicidal (C-SSRS≥4) or homicide risk, or currently in crisis such that inpatient hospitalization or other crisis management should take priority
History of any or psychotic or bipolar disorder
Alcohol or substance use disorder, post-traumatic stress disorder, obsessive-compulsive disorder and eating disorders within the preceding 12 months
History of dementia, traumatic brain injury (TBI), or neurological disorders affecting the brain, including any history of stroke or seizure disorders requiring treatment in the last 5 years (even if controlled with medications)
Cognitive impairment significant as determined by the Montreal Cognitive Assessment (MOCA) <22

Show all 20Show fewer

History of antisocial personality disorder, or any clinically significant personality trait that would, in the investigator's judgment, preclude safe study participation or impair ability to remain adherent with the treatment protocol.
History of significant treatment non-adherence or situations where the subjects are unlikely to adhere to treatment, in the opinion of the investigator
Pregnant (as confirmed by pregnancy test at screen) or nursing.
Currently undergoing device-based treatment for depression or taking medications for depression other than SSRIs or SNRIs.
Treatment resistance with failure to respond to more than two adequate treatments with FDA-approved antidepressant medications during current episode of major depressive disorder.
History of ECT in the last 12 months; lifetime history of VNS; lifetime treatment resistance to any FDA-approved device-based treatment for major depressive disorder; device-based interventions for depression will need to be discontinued at least 8 weeks prior to screen.
Serious, unstable medical illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, hematologic disease; defined as any medical illness which is not well-controlled with standard-of-care medications
Clinically significant abnormal findings of laboratory parameters including urine toxicology screen for drugs of abuse or at physical examination
Clinical or laboratory evidence of uncontrolled hypothyroidism; if maintained on thyroid medication must be euthyroid for at least 1 month before screening.
Past intolerance or hypersensivity to t-PBM.
Significant skin conditions on the subject's scalp that are found in the area of the procedure sites.
Any use of light-activated drugs (photodynamic therapy) within 14 days prior to study enrollment.
Any type of implants in the head, whose functioning might be affected by t-PBM.
Failure to meet standard MRI safety requirements as determined by the MRI Safety Checklist.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

Massachusetts General Hospital
Charlestown, Massachusetts, 02129
New York University
New York, New York, 10016
Nathan Kline Institute
Orangeburg, New York, 10962

Other trials in United States

About this study

This study will compare the effect of three transcranial photobiomodulation (t-PBM) doses (high, middle, and low irradiance) to sham t-PBM on PFC CBF as assessed with fMRI (BOLD) in this multi-center, phase I, double-blinded, dose-ranging, controlled, crossover study of 30 subjects with MDD. All eligible participants will undergo four sessions of t-PBM during fMRI so that they experience irradiances of 50, 300 and 700 mW/cm2 as well as sham. The order of dose administration will be randomized and t-PBM will be administered with the LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0).

Read the detailed description

The purpose of this research study is to determine if application of near infrared energy to the forehead can change blood flow in the brains of people with depression. Near infrared energy is like light but is not visible to the human eye. This research study will compare near infrared exposure with a placebo or sham procedure. The sham procedure will look and feel just like the near infrared procedure but won't include near infrared exposure.

Conditions: Major Depressive Disorder
Being tested: Transcranial Photobiomodulator, Sham
Keywords: MDD, neuromodulation, transcranial photobiomodulation
Medical subject headings: Depressive Disorder, Major

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transcranial PhotobiomodulatorDevice
Also called LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)
Delivers laser-generated Near-Infrared Radiation (NIR) to forehead at 3 doses of irradiance - High (770 mW/cm2), Middle (300 mW/cm2), and Low (50 mW/cm2).
ShamDevice
Transcranial Photobiomodulator delivers sham irradiance dose of 0 mW/cm2.

Study groups in NCT04366258
Study group	Role	What they receive
Patients with MDD	Experimental	Participants will undergo 4 Transcranial Photobiomodulation (t-PBM) treatment visits and receive 1 irradiance dose per visit. The order of dose administration is randomized so patients receive each irradiance dose (50 mW/cm2; 300 mW/cm2; 770 mW/cm2), as well as a sham dose (0 mW/cm2), once over the 4 treatment visits. Receives: Device: Transcranial Photobiomodulator; Device: Sham

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During High-Irradiance t-PBM
CBF is measured as Blood Oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflects changes in regional CBF that delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change indicates that blood flow increased in the region of interest between scans, a negative percent change indicates blood flow decreased between scans.
Approximately 60 minutes of fMRI data are recorded in the left and right dorsolateral prefrontal cortical regions of interest at each transcranial photobiomodulation (t-PBM) treatment visit, including: approximately 20 minutes prior to t-PBM administration, approximately 20 minutes coinciding with t-PBM administration, and approximately 20 minutes following t-PBM administration.
Measured: 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7
Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Middle-Irradiance t-PBM
CBF is measured as Blood Oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflects changes in regional CBF that delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change indicates that blood flow increased in the region of interest between scans, a negative percent change indicates blood flow decreased between scans.
Approximately 60 minutes of fMRI data are recorded in the left and right dorsolateral prefrontal cortical regions of interest at each transcranial photobiomodulation (t-PBM) treatment visit, including: approximately 20 minutes prior to t-PBM administration, approximately 20 minutes coinciding with t-PBM administration, and approximately 20 minutes following t-PBM administration.
Measured: 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7
Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Low-Irradiance t-PBM
CBF is measured as Blood Oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflects changes in regional CBF that delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change indicates that blood flow increased in the region of interest between scans, a negative percent change indicates blood flow decreased between scans.
Approximately 60 minutes of fMRI data are recorded in the left and right dorsolateral prefrontal cortical regions of interest at each transcranial photobiomodulation (t-PBM) treatment visit, including: approximately 20 minutes prior to t-PBM administration, approximately 20 minutes coinciding with t-PBM administration, and approximately 20 minutes following t-PBM administration.
Measured: 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7
Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Sham Treatment
CBF is measured as Blood Oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflects changes in regional CBF that delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change indicates that blood flow increased in the region of interest between scans, a negative percent change indicates blood flow decreased between scans.
Approximately 60 minutes of fMRI data are recorded in the left and right dorsolateral prefrontal cortical regions of interest at each transcranial photobiomodulation (t-PBM) treatment visit, including: approximately 20 minutes prior to t-PBM administration, approximately 20 minutes coinciding with t-PBM administration, and approximately 20 minutes following t-PBM administration.
Measured: 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7

Secondary outcomes (14)

Change in Brain Temperature During High-Irradiance t-PBM
Changes computed using data recorded with magnetic resonance (MR) thermometry scans taken immediately before and after the 20-minute transcranial photobiomodulation (t-PBM) treatment administration.
Measured: Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7
Change in Brain Temperature During Middle-Irradiance t-PBM
Changes computed using data recorded with magnetic resonance (MR) thermometry scans taken immediately before and after the 20-minute transcranial photobiomodulation (t-PBM) treatment administration.
Measured: Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7
Change in Brain Temperature During Low-Irradiance t-PBM
Changes computed using data recorded with magnetic resonance (MR) thermometry scans taken immediately before and after the 20-minute transcranial photobiomodulation (t-PBM) treatment administration.
Measured: Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7
Change in Brain Temperature During Sham Treatment
Changes computed using data recorded with magnetic resonance (MR) thermometry scans taken immediately before and after the 20-minute transcranial photobiomodulation (t-PBM) treatment administration.
Measured: Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7
Change in Columbia Suicide Severity Rating Scale (C-SSRS) Suicide Ideation Score
C-SSRS systematically tracks suicidal ideation and behavior. The total score range is 0 (no ideation is present) to 5 (active suicidal ideation with specific plan and intent). The higher the score, the greater one's suicidal ideation. Any score greater than 0 is important and may indicate the need for mental health intervention.
Measured: Baseline, Follow-up (Week 8)
Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Prior to First Treatment
55-item self-assessment measuring severity levels of side effects. Participants rank each item on a 4-point Likert scale ranging from 0-3, where: 0 = None; 1 = Mild; 2 = Moderate; and 3 = Severe. The total score is the sum of responses. Scores range from 0 to 165; higher scores indicate greater severity of side effects
Measured: Baseline
Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following High-Irradiance t-PBM
55-item self-assessment measuring severity levels of side effects. Participants rank each item on a 4-point Likert scale ranging from 0-3, where: 0 = None; 1 = Mild; 2 = Moderate; and 3 = Severe. The total score is the sum of responses. Scores range from 0 to 165; higher scores indicate greater severity of side effects
Measured: Immediately Post-Intervention, up to Week 7 in total
Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Middle-Irradiance t-PBM
55-item self-assessment measuring severity levels of side effects. Participants rank each item on a 4-point Likert scale ranging from 0-3, where: 0 = None; 1 = Mild; 2 = Moderate; and 3 = Severe. The total score is the sum of responses. Scores range from 0 to 165; higher scores indicate greater severity of side effects
Measured: Immediately Post-Intervention, up to Week 7 in total
Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Low-Irradiance t-PBM
55-item self-assessment measuring severity levels of side effects. Participants rank each item on a 4-point Likert scale ranging from 0-3, where: 0 = None; 1 = Mild; 2 = Moderate; and 3 = Severe. The total score is the sum of responses. Scores range from 0 to 165; higher scores indicate greater severity of side effects
Measured: Immediately Post-Intervention, up to Week 7 in total
Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Sham Treatment
55-item self-assessment measuring severity levels of side effects. Participants rank each item on a 4-point Likert scale ranging from 0-3, where: 0 = None; 1 = Mild; 2 = Moderate; and 3 = Severe. The total score is the sum of responses. Scores range from 0 to 165; higher scores indicate greater severity of side effects
Measured: Immediately Post-Intervention, up to Week 7 in total
t-PBM Self-Report Questionnaire (TSRQ) Score Following High-Irradiance t-PBM
3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales.
The total score is the sum of responses. Total score ranges from 3-18; higher scores indicate greater perceived inconveniences and discomforts associated with t-PBM use.
Measured: Immediately Post-Intervention, up to Week 7 in total
t-PBM Self-Report Questionnaire (TSRQ) Score Following Middle-Irradiance t-PBM
3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales.
The total score is the sum of responses. Total score ranges from 3-18; higher scores indicate greater perceived inconveniences and discomforts associated with t-PBM use.
Measured: Immediately Post-Intervention, up to Week 7 in total
t-PBM Self-Report Questionnaire (TSRQ) Score Following Low-Irradiance t-PBM
3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales.
The total score is the sum of responses. Total score ranges from 3-18; higher scores indicate greater perceived inconveniences and discomforts associated with t-PBM use.
Measured: Immediately Post-Intervention, up to Week 7 in total
t-PBM Self-Report Questionnaire (TSRQ) Score Following Sham Treatment
3-item self-report assessment of potential inconveniences and discomforts from the transcranial photobiomodulation (t-PBM). Participants rank each item on various Likert scales.
The total score is the sum of responses. Total score ranges from 3-18; higher scores indicate greater perceived inconveniences and discomforts associated with t-PBM use.
Measured: Immediately Post-Intervention, up to Week 7 in total

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202024 Jun 2022

First posted28 Apr 2020
Study start1 Aug 2020
Primary completion30 Apr 2022
Study completion24 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
More trials run by NYU Langone HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04366258
Sponsor's protocol ID: 20-00217
Other IDs: 1R61MH122647-01
Acronym: TRIADE
Status last verified: May 2023
First submitted: 17 Apr 2020
Last updated: 5 Jun 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

Publications

Iosifescu DV, Collins KA, Tural U, Dmochowski JP, Gaggi N, Parincu Z, Peterson A, Hurtado-Puerto AM, Gersten MB, Clancy JA, McEachern KM, Sobeih T, de Taboada L, Tarpey T, Cassano P. Dose Dependent Effects of Transcranial Photobiomodulation on Blood-Oxygenation-Level-Dependent Power in Major Depressive Disorder. Brain Stimul. 2026 Aug 13:103185. doi: 10.1016/j.brs.2026.103185. Online ahead of print.
PubMed 42595101

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Major Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression
ClinicalTrials.gov ID: NCT04366258
Acronym / sponsor ID: TRIADE / 20-00217
Conditions: Major Depressive Disorder
Keywords: MDD, neuromodulation, transcranial photobiomodulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: NYU Langone HealthUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 1 Aug 2020 (actual)
Primary completion: 30 Apr 2022 (actual)
Study completion: 24 Jun 2022 (actual)
First posted: 28 Apr 2020 (actual)
Results: Posted 5 Jun 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Patients with MDD	Experimental	Device: Transcranial Photobiomodulator, Device: ShamParticipants will undergo 4 Transcranial Photobiomodulation (t-PBM) treatment visits and receive 1 irradiance dose per visit. The order of dose administration is randomized so patients receive each irradiance dose (50 mW/cm2; 300 mW/cm2; 770 mW/cm2), as well as a sham dose (0 mW/cm2), once over the 4 treatment visits.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Participants must be able to give written informed consent and follow study procedures
Participants must have major depressive disorder; all the following conditions need to be met to ensure presence of significant depression symptoms:
Women of child-bearing potential must agree to use adequate contraception
Participants taking medications or psychotherapy approved for the treatment of major depressive disorder will need to be stable for at least 8 weeks prior to screen

Key exclusion criteria (20 listed)

Unwilling or unable to comply with study requirements
Participants who are judged to be at serious and imminent suicidal (C-SSRS≥4) or homicide risk, or currently in crisis such that inpatient hospitalization or other crisis management should take priority
History of any or psychotic or bipolar disorder
Alcohol or substance use disorder, post-traumatic stress disorder, obsessive-compulsive disorder and eating disorders within the preceding 12 months
History of dementia, traumatic brain injury (TBI), or neurological disorders affecting the brain, including any history of stroke or seizure disorders requiring treatment in the last 5 years (even if controlled with medications)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transcranial PhotobiomodulatorAlso: LightForce® EXPi Deep Tissue Laser TherapyTM System, Transcranial PhotoBioModulation-1000 (tPBM-2.0)Delivers laser-generated Near-Infrared Radiation (NIR) to forehead at 3 doses of irradiance - High (770 mW/cm2), Middle (300 mW/cm2), and Low (50 mW/cm2).	Device	Patients with MDD
ShamTranscranial Photobiomodulator delivers sham irradiance dose of 0 mW/cm2.	Device	Patients with MDD

Primary outcome

Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During High-Irradiance t-PBM
Time frame: 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7
CBF is measured as Blood Oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflects changes in regional CBF that delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change indicates that blood flow increased in the region of interest between scans, a negative percent change indicates blood flow decreased between scans. Approximately 60 minutes of fMRI data are recorded in the left and right dorsolateral prefrontal cortical regions of interest at each transcranial photobiomodulation (t-PBM) treatment visit, including: approximately 20 minutes prior to t-PBM administration, approximately 20 minutes coinciding with t-PBM administration, and approximately 20 minutes following t-PBM administration.
Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Middle-Irradiance t-PBM
Time frame: 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7
CBF is measured as Blood Oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflects changes in regional CBF that delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change indicates that blood flow increased in the region of interest between scans, a negative percent change indicates blood flow decreased between scans. Approximately 60 minutes of fMRI data are recorded in the left and right dorsolateral prefrontal cortical regions of interest at each transcranial photobiomodulation (t-PBM) treatment visit, including: approximately 20 minutes prior to t-PBM administration, approximately 20 minutes coinciding with t-PBM administration, and approximately 20 minutes following t-PBM administration.
Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Low-Irradiance t-PBM
Time frame: 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7
CBF is measured as Blood Oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflects changes in regional CBF that delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change indicates that blood flow increased in the region of interest between scans, a negative percent change indicates blood flow decreased between scans. Approximately 60 minutes of fMRI data are recorded in the left and right dorsolateral prefrontal cortical regions of interest at each transcranial photobiomodulation (t-PBM) treatment visit, including: approximately 20 minutes prior to t-PBM administration, approximately 20 minutes coinciding with t-PBM administration, and approximately 20 minutes following t-PBM administration.
Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Sham Treatment
Time frame: 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7
CBF is measured as Blood Oxygen Level Dependent (BOLD) signal on functional magnetic resonance imaging (fMRI). BOLD signal reflects changes in regional CBF that delineate regional activity. A positive BOLD signal marks an increase in regional blood flow, while a negative BOLD signal marks a decrease in regional blood flow. A positive percent change indicates that blood flow increased in the region of interest between scans, a negative percent change indicates blood flow decreased between scans. Approximately 60 minutes of fMRI data are recorded in the left and right dorsolateral prefrontal cortical regions of interest at each transcranial photobiomodulation (t-PBM) treatment visit, including: approximately 20 minutes prior to t-PBM administration, approximately 20 minutes coinciding with t-PBM administration, and approximately 20 minutes following t-PBM administration.

14 secondary outcomes

Change in Brain Temperature During High-Irradiance t-PBM
Time frame: Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7
Change in Brain Temperature During Middle-Irradiance t-PBM
Time frame: Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7
Change in Brain Temperature During Low-Irradiance t-PBM
Time frame: Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7
Change in Brain Temperature During Sham Treatment
Time frame: Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7
Change in Columbia Suicide Severity Rating Scale (C-SSRS) Suicide Ideation Score
Time frame: Baseline, Follow-up (Week 8)
Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Prior to First Treatment
Time frame: Baseline
Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following High-Irradiance t-PBM
Time frame: Immediately Post-Intervention, up to Week 7 in total
Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Middle-Irradiance t-PBM
Time frame: Immediately Post-Intervention, up to Week 7 in total
Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Low-Irradiance t-PBM
Time frame: Immediately Post-Intervention, up to Week 7 in total
Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Sham Treatment
Time frame: Immediately Post-Intervention, up to Week 7 in total
t-PBM Self-Report Questionnaire (TSRQ) Score Following High-Irradiance t-PBM
Time frame: Immediately Post-Intervention, up to Week 7 in total
t-PBM Self-Report Questionnaire (TSRQ) Score Following Middle-Irradiance t-PBM
Time frame: Immediately Post-Intervention, up to Week 7 in total
t-PBM Self-Report Questionnaire (TSRQ) Score Following Low-Irradiance t-PBM
Time frame: Immediately Post-Intervention, up to Week 7 in total
t-PBM Self-Report Questionnaire (TSRQ) Score Following Sham Treatment
Time frame: Immediately Post-Intervention, up to Week 7 in total

Results and safety

Results posted to the registry on 5 Jun 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With MDD	55	31

Primary outcome: Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During High-Irradiance t-PBM

Time frame: 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7. Mean (Standard Deviation). Unit: Percent change in raw frontal BOLD

Measure	t-PBM at High Irradiance n = 27
Value	1.12 (25.07)

Primary outcome: Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Middle-Irradiance t-PBM

Time frame: 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7. Mean (Standard Deviation). Unit: Percent change in raw frontal BOLD

Measure	t-PBM at Medium Irradiance n = 29
Value	100.36 (70.72)

Primary outcome: Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Low-Irradiance t-PBM

Time frame: 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7. Mean (Standard Deviation). Unit: Percent change in raw frontal BOLD

Measure	t-PBM at Low Irradiance n = 29
Value	-43.51 (25.2)

Primary outcome: Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During Sham Treatment

Time frame: 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7. Mean (Standard Deviation). Unit: Percent change in raw frontal BOLD

Measure	Sham n = 29
Value	1.99 (30.65)

14 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
t-PBM at High Irradiance	0 of 27 (0%)	6 of 27 (22.2%)	0 of 27
t-PBM at Medium Irradiance	0 of 26 (0%)	7 of 26 (26.9%)	0 of 26
t-PBM at Low Irradiance	0 of 28 (0%)	8 of 28 (28.6%)	0 of 28
Sham	0 of 29 (0%)	6 of 29 (20.7%)	0 of 29

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42595101Iosifescu DV, Collins KA, Tural U, Dmochowski JP, Gaggi N, Parincu Z, Peterson A, Hurtado-Puerto AM, Gersten MB, Clancy JA, McEachern KM, Sobeih T, de Taboada L, Tarpey T, Cassano P. Dose Dependent Effects of Transcranial Photobiomodulation on Blood-Oxygenation-Level-Dependent Power in Major Depressive Disorder. Brain Stimul. 2026 Aug 13:103185. doi: 10.1016/j.brs.2026.103185. Online ahead of print.
Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Dan Iosifescu, MD principal investigator

NYU Langone Health

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transcranial Photobiomodulator in people with Major Depressive Disorder, run by NYU Langone Health at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jun 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage Change in Prefrontal Cortex (PFC) Cerebral Blood Flow (CBF) During High-Irradiance t-PBM (time frame: 20 Minutes Pre-Intervention, 20 Minutes Post-Intervention (Total duration: 60 min); Up to Week 7). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04366258, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.