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

> **NIH NIH R61** · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · 2021 · $800,939

## Abstract

PROJECT SUMMARY
 Major depressive disorder (MDD) is associated with high rates of disability, as well as suicidal ideation and
behavior. Current treatments for MDD have significant limitations in efficacy and side effect burden, while FDA-
approved devices for MDD are burdensome and only suitable for severely ill subjects. There is a critical need
for device-based treatments in MDD that are efficacious, well-tolerated and easy to use. Transcranial
photobiomodulation (t-PBM) with near-infrared (NIR) light penetrates robustly into the cerebral cortex and
 This project focuses on the adjunctive use of the transcranial photobiomodulation (t-PBM) with near-
infrared (NIR) light for the treatment of MDD. t-PBM with near-infrared (NIR) light penetrates robustly into the
cerebral cortex, stimulating the mitochondrial respiratory chain, and also significantly increases cerebral blood
flow (CBF). In the R61 phase, we will conduct target engagement studies to demonstrate dose-dependent
effects of t-PBM on the prefrontal cortex (PFC) CBF, using the increase in fMRI blood-oxygenation-level
dependent (BOLD) signal levels as our Go/No-go target engagement biomarker. In the R33 phase, we will
conduct a randomized clinical trial of t-PBM vs. sham for in MDD, to establish the target engagement and
evaluate the association between changes in the biomarker (BOLD signal) and changes in clinical symptoms,
while also collecting important information on antidepressant effects, safety and tolerability. The study will be
done in parallel at the New York University/ Nathan Kline Institute and at Massachusetts General Hospital.
 The importance of this study is threefold: (1) it targets MDD, a leading cause of disability wordwide, which
lacks adequate treatments, (2) it evaluates t-PBM, which has a well-established safety profile and has the
potential to be safe in at-home administration, and (3) uses fMRI BOLD changes as a target engagement
biomarker. If effects are confirmed, the present study will both support short-term clinical development of an
easy to scale device for the treatment of MDD, while also validating a biomarker for the development of future,
novel modulation strategies.

## Key facts

- **NIH application ID:** 10135145
- **Project number:** 5R61MH122647-02
- **Recipient organization:** NEW YORK UNIVERSITY SCHOOL OF MEDICINE
- **Principal Investigator:** PAOLO CASSANO
- **Activity code:** R61 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $800,939
- **Award type:** 5
- **Project period:** 2020-04-01 → 2023-02-28

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10135145

## Citation

> US National Institutes of Health, RePORTER application 10135145, Transcranial Near Infrared Radiation and Cerebral Blood Flow in Depression (TRIADE) (5R61MH122647-02). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10135145. Licensed CC0.

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