NCT07510646Not yet recruiting
Transcranial Photobiomodulation for Bipolar Depression
A Pilot Clinical Trial for the Efficacy and Safety of Transcranial Photobiomodulation (tPBM) in Improving Symptoms of Bipolar Depression
Source: ClinicalTrials.gov · Last updated 3 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 16 Mar 2025
- Start date
- 1 Jul 2026
- Primary completion date
- 1 Jul 2027
- Lead sponsor
- Vielight Inc.
- Diseases
- Bipolar disorder
- NCT number
- NCT07510646
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Jul 2026 to the primary completion date, 1 Jul 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently in manic or mixed episode, as measured by Young Mania Rating Scale (YMRS) more than 8-10
- Currently psychotic
- Judged to be at serious and imminent suicidal risk
- Currently has alcohol or substance use disorder (meeting criteria in the past 1 months)
- Unstable medical conditions
- Inability to consent or to complete study procedures
- Changes in medications or use of augmentative devices and other interventions in the 4 weeks prior to the study
- Participation in other clinical research trials that may influence primary outcomes or adherence to the proposed study
- Current pregnancy or intention to become pregnant
Who the study is looking for
- • Diagnosis of bipolar depression
- Montgomery-Asberg Depression Rating Scale (MADRS) of 24 or higher
- Capable of providing consent
- Currently inpatient or outpatient
- Ability to communicate in spoken and written English fluently enough to complete the required study assessments
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Providence care Hospital Coordinator of this site? Confirm its status | Kingston | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.