NCT04366258

Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

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

Interventions

Type	Name	Description
DEVICE	Transcranial Photobiomodulator	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	Sham	Transcranial Photobiomodulator delivers sham irradiance dose of 0 mW/cm2.

Timeline

• Start date: 2020-08-01
• Primary completion: 2022-04-30
• Completion: 2022-06-24
• First posted: 2020-04-28
• Last updated: 2023-06-05
• Results posted: 2023-06-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study