NCT04366258: TRIADE

Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression

Completed NA Results posted Last updated 5 June 2023

What this trial tests

NA trial testing Transcranial Photobiomodulator in Major Depressive Disorder in 55 participants. Completed in 24 June 2022.

Timeline

1 August 2020

Primary endpoint
30 April 2022

24 June 2022

Quick facts

Lead sponsor	NYU Langone Health
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	55
Start date	1 August 2020
Primary completion	30 April 2022
Estimated completion	24 June 2022
Sites	3 locations across United States

Drugs / interventions tested

• Transcranial Photobiomodulator
• Sham

Conditions studied

• Major Depressive Disorder — all drugs for Major Depressive Disorder →

Sponsor

NYU Langone Health — full company profile →

Who can join

Adults 18 to 65, any sex, with Major Depressive Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
t-PBM at High Irradiance	1.12	± 25.07

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

Group	Value	95% CI
t-PBM at Medium Irradiance	100.36	± 70.72

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

Group	Value	95% CI
t-PBM at Low Irradiance	-43.51	± 25.2

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

Group	Value	95% CI
Sham	1.99	± 30.65

Change in Brain Temperature During High-Irradiance t-PBM Secondary · Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7

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.

Group	Value	95% CI
t-PBM at High Irradiance	-0.38	± 0.91

Change in Brain Temperature During Middle-Irradiance t-PBM Secondary · Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7

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.

Group	Value	95% CI
t-PBM at Medium Irradiance	-0.4	± 0.86

Change in Brain Temperature During Low-Irradiance t-PBM Secondary · Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7

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.

Group	Value	95% CI
t-PBM at Low Irradiance	-0.1	± 0.81

Change in Brain Temperature During Sham Treatment Secondary · Immediately Pre-Intervention, Immediately Post-Intervention; Up to Week 7

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.

Group	Value	95% CI
Sham	-0.33	± 0.49

Change in Columbia Suicide Severity Rating Scale (C-SSRS) Suicide Ideation Score Secondary · Baseline, Follow-up (Week 8)

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.

Group	Value	95% CI
Overall Study Population	0.07	± 0.83

Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Prior to First Treatment Secondary · Baseline

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

Group	Value	95% CI
Overall Study Population	27.81	± 11.26

Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following High-Irradiance t-PBM Secondary · Immediately Post-Intervention, up to Week 7 in total

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

Group	Value	95% CI
t-PBM at High Irradiance	21.19	± 12.04

Systematic Assessment for Treatment Emergent Events (SAFTEE) Score Following Middle-Irradiance t-PBM Secondary · Immediately Post-Intervention, up to Week 7 in total

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

Group	Value	95% CI
t-PBM at Medium Irradiance	20.1	± 13.04

Adverse events — posted to ClinicalTrials.gov

Time frame: 4 weeks. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

t-PBM at High Irradiance

Serious: 0/27 (0%)

Deaths: 0/27

t-PBM at Medium Irradiance

Serious: 0/26 (0%)

Deaths: 0/26

t-PBM at Low Irradiance

Serious: 0/28 (0%)

Deaths: 0/28

Sham

Serious: 0/29 (0%)

Deaths: 0/29

Other adverse events (9 terms — click to expand)

Reaction	System	t-PBM at High Irradiance	t-PBM at Medium Irradiance	t-PBM at Low Irradiance	Sham
Warm Skin (forehead)	Skin and subcutaneous tissue disorders	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Insomnia	Psychiatric disorders	—	—	—	—
Skin Pressure (forehead)	Skin and subcutaneous tissue disorders	—	—	—	—
Claustrophobia	Psychiatric disorders	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—
Nightmares	Psychiatric disorders	—	—	—	—
Eye Irritation	Eye disorders	—	—	—	—
Confusion	Psychiatric disorders	—	—	—	—

Data from ClinicalTrials.gov NCT04366258 adverse events section.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Neurometabolite Changes After Transcranial Photobiomodulation in Major Depressive Disorder: A Randomized Controlled Trial Investigating Dose-Dependent Effects.
   Coelho DRA, Tural Ü, Hurtado Puerto AM, Collins KA, et al · · 2025 · cited 3× · PMID 40429396 · DOI 10.3390/jcm14103402