Trial of Transcranial Photobiomodulation for Depression With PET and EEG Outcomes

NACompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

August 24, 2022

Primary Completion Date

August 1, 2025

Study Completion Date

August 1, 2025

Conditions
DepressionDepression, AnxietyDepressive DisorderDepressive Disorder, Major
Interventions
DEVICE

Bilateral Near-Infrared Transcranial Photobiomodulation (tPBM)

The system delivers 808 nm near-infrared light via fiber optics through a headset forming \~12 cm² beams at EEG sites AF3/AF4 (dorsolateral prefrontal cortex). Participants are randomized to: (1) Continuous Wave (CW, high dose) \~350 mW/cm² (\~8.4 W total); (2) Continuous Wave Low Dose (CW\_LOW) \~50 mW/cm² (\~1.2 W); (3) Pulsed Wave (PW) peak \~1050 mW/cm², 42 Hz, 33% duty cycle (avg \~350 mW/cm²); or (4) Sham device with identical cues but no light. Sessions last 429 s, 3×/week for 6 weeks (18 total). Sham matches duration/procedures. Outcomes include depressive symptoms (HAMD-17, QIDS, SDQ), FDG-PET, and EEG.

Trial Locations (2)

15036

Clinica Vesalio, Lima

L01

Hospital Nacional Guillermo Almenara Irigoyen, Lima

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Peruvian Clinical Research

OTHER

lead

NeuroThera DE

INDUSTRY