Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression - R33
NYU Langone Health
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.
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.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants must be able to give written informed consent and follow study procedures * Participants must be 18-65 years of age * Participants must have major depressive disorder; all the following conditions need to be met to ensure presence of significant depression symptoms: 1. Meeting diagnostic criteria for Major Depressive Disorder (MDD) in the past two weeks, at the DSM-5 Mini-International Neuropsychiatric Interview (MINI) 2. Inventory for Depressive Symptomatology Clinician-rated (IDS-C) total score ≥23 at screening 3. Depression symptoms are the primary…
Interventions
- DeviceTranscranial Photobiomodulator
Transcranial photobiomodulator delivers Near-Infrared Radiation (NIR) continuous middle irradiance (291.7 mW/cm2) to patients' foreheads.
- DeviceSham
Transcranial Photobiomodulator delivers sham irradiance odes of 0 mW/cm2
Locations (3)
- Harvard Medical SchoolBoston, Massachusetts
- NYU Langone HealthNew York, New York
- Nathan Kline Institute for Psychiatric ResearchOrangeburg, New York