CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 13 enrolled
Drug / intervention
Transcranial Phoobiomodulation (tPBM)device
Likely dose
Not stated in record
Key inclusion· 4
  • Age 18–65 years
  • Confirmed diagnosis of bipolar disorder
  • Currently experiencing symptoms of impulsivity
  • Vision normal or corrected to normal with contacts
Key exclusion· 8
  • Currently in depressive, manic, or mixed episode
  • Currently psychotic
  • Assessed as at serious and imminent suicidal risk
  • Active alcohol or substance use disorder (meeting criteria in past 3 months)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05408637
NCT05408637Phase 2Completed

Transcranial Photobiomodulation for Executive Function in Bipolar Disorder (TPEB)

Paolo Cassano·interventional·Posted Jun 7, 2022·Updated Aug 28, 2025

In Brief

A Phase 2 clinical trial evaluating Transcranial Phoobiomodulation (tPBM) for Bipolar Disorder. Completed, enrolled 13 participants across 1 site.

Detailed Summary

Transcranial light therapy, or transcranial photobiomodulation (tPBM), is a treatment that stimulates the brain by applying near-infrared light to the forehead. Transcranial light therapy has been found to promote brain metabolism, which may help improve executive function in people with bipolar disorder. The research team proposes a novel approach to treating bipolar disorder by using transcranial light therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2023202420252026
First PostedJun 7, 2022
Enrollment StartAug 9, 2022
Primary CompletionMay 14, 2024
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 4.1 years ago

Interventions

Transcranial Phoobiomodulation (tPBM)device

Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.