๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-04-01

Transcranial Photobiomodulation for Bipolar Depression (NCT07510646)

A Pilot Clinical Trial for the Efficacy and Safety of Transcranial Photobiomodulation (tPBM) in Improving Symptoms of Bipolar Depression

๐ŸŸก Not Yet Recruiting Observational / Diagnostic โš™๏ธ Medical Device Protocol Sponsor: Vielight Inc.

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Providence Care Hospital โ€” Kingston, Ontario

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (1 Sites)

  • Providence Care Hospital โ€” Kingston, Ontario

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—