Transcranial Photobiomodulation for Executive Function in Bipolar Disorder

NCT05408637 | Completed Phase 2 Results FDA Device

• 1 other identifier: 2022p000289
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Disorder

Keywords

Bipolar; Bipolar Disorder

Outcome Measures

Primary Outcomes (2)

• Test the Effect of Transcranial Photobiomodulation (tPBM) on Cerebral Blood Flow (CBF)

  Compare blood-oxygenation-level-dependent (BOLD) signal during sham stimulation at Day 1 versus BOLD signal during active stimulation at Day 1. Increased BOLD signal is thought to reflect increased brain activity, and thus a positive outcome. In this specific case, higher BOLD signal during active as compared to sham treatment in the right dorsolateral prefrontal cortex (rDLPFC) is thought to reflect target engagement, that is the tPBM device which is placed on the right forehead is in fact irradiating and having an effect on brain function within the rDLPFC.

  Day 1 of tPBM Treatment

• Test Effect of tPBM on CBF

  Compare BOLD signal during active stimulation at Day 1 versus active stimulation at Day 5. Greater BOLD signal at Day 5 compared to Day 1 would indicate an increase in brain activity following active treatment, supporting tPBM target engagement.

  Day 1 and Day 5

Secondary Outcomes (2)

• Test the Effect of tPBM on Impaired Decision Making

  Baseline to Follow-Up

• Test the Effect of Repeated t-PBM Sessions on Mood Symptoms (MOODS-SR) in Subjects With Bipolar Disorder (BD)

  Baseline to Follow Up

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.

Also known as: Transcranial Light Therapy, Low Level Laser-Light Therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Paolo Cassano: lead

Study Sites (1)

Mass General Hospital Navy Yard Building 149

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Low-Level Light Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Limitations and Caveats

The sample size is small, limiting statistical analyses and interpretation. The results highlight the need for group-level statistical analyses in a larger sample to validate. The inter-individual variability suggests that future studies should include additional longitudinal tracking and more examination of moderating factors.

Results Point of Contact

• Title: Dr. Paolo Cassano
• Organization: Massachusetts General Hospital and Harvard Medical School

pcassano@mgh.harvard.edu

617-643-9622

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: During the first treatment visit within the MRI, participants will receive one active tPBM treatment and one sham tPBM treatment. Participants will be blinded as to the order in which they receive these treatments.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Photobiomodulation

Model Details: All participants will receive five active tPBM treatments and one sham tPBM treatment.

Study Record Dates

• First Submitted: May 17, 2022
• First Posted: June 7, 2022
• Study Start: August 9, 2022
• Primary Completion: May 14, 2024
• Study Completion: May 14, 2024
• Last Updated: August 28, 2025
• Results First Posted: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)