Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression
(TRIADE Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byDan Iosifescu, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: NYU Langone Health

No Placebo Group

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

Inclusion Criteria

Participants must be able to give written informed consent and follow study procedures

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

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Treatment Details

Interventions

Sham (Procedure)
Transcranial photobiomodulator (Procedure)
Transcranial Photobiomodulator (Procedure)

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Patients with MDDExperimental Treatment2 Interventions

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.