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Transcranial Photobiomodulation for Bipolar Depression

NCT07510646 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-04-03

No results posted yet for this study

Summary

This study the effectiveness and safety of light therapy device targeted at the brain using a wearable device, the Vielight RX Gamma as a treatment for bipolar depression. Up to forty patients with bipolar disorder will be enrolled into the study and will either receive active treatment with the Vielight RX Gamma or sham (inactive device). They will be administered the devices in clinic 5days/week for 6 weeks. Changes in disease symptoms, cognitive function, pain, quality of life and rest EEG changes will be assessed.

Conditions

  • Bipolar
  • Bipolar Disorder (BD)
  • Bipolar Disorder Depression

Interventions

DEVICE

Vielight Neuro Rx Gamma

Participants assigned to the intervention will be administered treatment with the Neuro Rx Gamma 5 days/week in clinic

DEVICE

Sham Device

Participant assigned to the sham device will be administered the sham device in clinic 5 days/week

Sponsors & Collaborators

  • Vielight Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-07-01
Completion
2027-07-01

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07510646 on ClinicalTrials.gov