CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 55 enrolled
Drug / intervention
Transcranial Photobiomodulator +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04366258
NCT04366258N/ACompleted
CompareCT.gov

Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression

NYU Langone Health·interventional·Posted Apr 28, 2020·Updated Jun 5, 2023

In Brief

A clinical study evaluating Transcranial Photobiomodulator and Sham for Major Depressive Disorder. Completed, enrolled 55 participants across 3 sites.

Detailed Summary

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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMajor Depressive Disorder
CountriesUnited States
CollaboratorsNational Institute of Mental Health (NIMH)

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedApr 28, 2020
Enrollment StartAug 1, 2020
Primary CompletionApr 30, 2022
Study CompletionJun 24, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.2 years ago

Interventions

Transcranial Photobiomodulatordevice

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.