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Phase 2 N=4 Single-blind Treatment

Transcranial Photobiomodulation for Executive Function in Bipolar Disorder

Bipolar Disorder

Bottom Line

View on ClinicalTrials.gov: NCT05408637 ↗
Enrolled (actual)
4
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcome: Primary: Test the Effect of Transcranial Photobiomodulation (tPBM) on Cerebral Blood Flow (CBF) — 6611.645; 6666.398 A.U.

Study Design & Population

Study type
Interventional
Phase
Phase 2
Interventions
Transcranial Phoobiomodulation (tPBM) (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Paolo Cassano
Primary completion
May 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Test the Effect of Transcranial Photobiomodulation (tPBM) on Cerebral Blood Flow (CBF)		 6611.645; 6666.398 —
PRIMARY
Test Effect of tPBM on CBF		 6666.398; 6891.237 —
SECONDARY
Test the Effect of tPBM on Impaired Decision Making		 3750; 4425; 4512.5; 4637.5; 762.5; 69.75 0.15
SECONDARY
Test the Effect of Repeated t-PBM Sessions on Mood Symptoms (MOODS-SR) in Subjects With Bipolar Disorder (BD)		 18.5; 21.5; 13.5; 3; -5 0.6

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.

Eligibility Criteria

Inclusion Criteria

  • Adults between the ages of 18 and 65
  • Diagnosis of bipolar disorder
  • Currently experiencing symptoms of impulsivity
  • Vision normal or corrected to normal with contacts

Exclusion Criteria

  • Currently in depressive, manic, or mixed episode
  • Currently psychotic
  • Judged to be at serious and imminent suicidal risk
  • Currently in alcohol or substance use disorder (meeting criteria in the past 3 months)
  • Unstable medical conditions
  • Inability to consent or to complete study procedures
  • Failure to meet standard MRI safety requirements (e.g. claustrophobia, non-removable piercings, implanted medical devices, other non-removable metals)
  • Changes in medications or use of augmentative devices and other interventions in the 2 weeks prior to the study
  • Participation in other clinical research trials that may influence primary outcomes or adherence to the proposed study
  • Current pregnancy.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05408637). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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