NCT05573074

Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression - R33

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

In this multi-center study, approximately 60 subjects with Major Depressive Disorder (MDD) will undergo Magnetic Resonance Imaging (MRI) scanning during transcranial Photobiomodulation (tPBM) before and after a randomized, double-blinded, controlled 16 session course of treatment with tPBM or sham.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DEVICE	Transcranial Photobiomodulator	Transcranial photobiomodulator delivers Near-Infrared Radiation (NIR) continuous middle irradiance (291.7 mW/cm2) to patients' foreheads.
DEVICE	Sham	Transcranial Photobiomodulator delivers sham irradiance odes of 0 mW/cm2

Timeline

• Start date: 2023-04-01
• Primary completion: 2026-04-30
• Completion: 2026-06-30
• First posted: 2022-10-10
• Last updated: 2026-02-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study