Transcranial Photobiomodulation for Executive Function in Bipolar Disorder

NCT ID: NCT05408637

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-09
• Study Completion Date: 2024-05-14

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.

Detailed Description

This study involves a virtual screening visit, 7 in-office visits, and a virtual check-in call with a clinician. Participation will last approximately 3 weeks in total.

Participants will attend a baseline visit during which they will complete mood questionnaires and a gambling task. Participants will then receive five treatments of transcranial light therapy over one week. The first and last of these treatments will be administered while the participant is in an MRI scanner. At the first visit, participants will also receive a "sham" tPBM treatment, meaning that the device will simulate real treatment, but will not actually apply the near-infrared light. The check-in call will occur approximately 2-3 days after the final treatment visit. This will be a brief call with a study clinician to check-in on the participant's mental and physical health. The follow up visit will occur approximately one week after the final visit. Subjects will be asked to complete mood questionnaires and/or gambling tasks during the first and fifth treatment visits, as well as at the follow up visit.

Conditions

Bipolar Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Transcranial Phoobiomodulation (tPBM)

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.

Intervention Type: DEVICE

Other Intervention Names

Transcranial Light Therapy; Low Level Laser-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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Paolo Cassano

OTHER

Sponsor Role: lead

Responsible Party

Paolo Cassano

Director of Photobiomodulation

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Mass General Hospital Navy Yard Building 149

Charlestown, Massachusetts, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2022p000289

Identifier Type: -

Identifier Source: org_study_id