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TPEB: Transcranial Photobiomodulation for Executive Function in Bipolar Disorder

Sponsor
Paolo Cassano (Other)
Overall Status
Recruiting
CT.gov ID
NCT05408637
Collaborator
(none)
20
Enrollment
1
Location
12
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial Phoobiomodulation (tPBM)
 Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All participants will receive five active tPBM treatments and one sham tPBM treatment.All participants will receive five active tPBM treatments and one sham tPBM treatment.
Masking:
Single (Participant)
Masking Description:
During the first treatment visit, 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.
Primary Purpose:
Treatment
Official Title:
Transcranial Photobiomodulation for Executive Function in Bipolar Disorder (TPEB)
Anticipated Study Start Date :
Sep 30, 2022
Anticipated Primary Completion Date :
Jun 30, 2023
Anticipated Study Completion Date :
Sep 30, 2023

Outcome Measures

Primary Outcome Measures

  1. Test the effect of tPBM on CBF [Day 1 and Day 5 of tPBM treatment]

    Change in cerebral blood flow (CBF) during a single session of tPBM (Day 1) and change in cerebral blood flow from baseline to final day of treatment (Day 5)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Adults between the ages of 18 and 65

  • Diagnosis of bipolar disorder

  • Currently experiencing symptoms of impulsivity

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 12 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mass General Hospital Navy Yard Building 149 Charlestown Massachusetts United States 02129

Sponsors and Collaborators

  • Paolo Cassano

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Paolo Cassano, Director of Photobiomodulation, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT05408637
Other Study ID Numbers:
  • 2022p000289
First Posted:
Jun 7, 2022
Last Update Posted:
Jun 7, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Paolo Cassano, Director of Photobiomodulation, Massachusetts General Hospital
Bipolar
Bipolar Disorder
Additional relevant MeSH terms:
Disease
Bipolar Disorder

Study Results

No Results Posted as of Jun 7, 2022