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Transcranial Photobiomodulation for Bipolar Depression
Sponsor: Vielight Inc.
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.
Official title: A Pilot Clinical Trial for the Efficacy and Safety of Transcranial Photobiomodulation (tPBM) in Improving Symptoms of Bipolar Depression
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
40
Start Date
2026-07-01
Completion Date
2027-07-01
Last Updated
2026-04-03
Healthy Volunteers
No
Interventions
Vielight Neuro Rx Gamma
Participants assigned to the intervention will be administered treatment with the Neuro Rx Gamma 5 days/week in clinic
Sham Device
Participant assigned to the sham device will be administered the sham device in clinic 5 days/week
Locations (1)
Providence Care Hospital
Kingston, Ontario, Canada