Brain light therapy with a wearable device for depression in bipolar disorder
Tests a wearable brain light device against an inactive one in bipolar depression.
Plain-language title generated from the registry record
Registry title: Transcranial Photobiomodulation for Bipolar Depression
Key facts
- Where
- Kingston, CanadaSee the site
Where in Canada
- Providence care HospitalKingston, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Vielight Inc.
- Trial code
- NCT07510646
- Record updated
- 3 April 2026
- Original description
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.Read full original descriptionShow less
A Pilot Clinical Trial for the Efficacy and Safety of Transcranial Photobiomodulation (tPBM) in Improving Symptoms of Bipolar Depression
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.
Inclusion: • 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.
Exclusion: 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.