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Transcranial Photobiomodulation for Executive Function in Bipolar Disorder (TPEB)

Primary Purpose

Bipolar Disorder

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Transcranial Phoobiomodulation (tPBM)
Sponsored by
Paolo Cassano
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring Bipolar, Bipolar Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mass General Hospital Navy Yard Building 149Recruiting

Outcomes

Primary Outcome Measures

Test the effect of tPBM on CBF
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)

Secondary Outcome Measures

Full Information

First Posted
May 17, 2022
Last Updated
June 3, 2022
Sponsor
Paolo Cassano
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1. Study Identification

Unique Protocol Identification Number
NCT05408637
Brief Title
Transcranial Photobiomodulation for Executive Function in Bipolar Disorder
Acronym
TPEB
Official Title
Transcranial Photobiomodulation for Executive Function in Bipolar Disorder (TPEB)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2022 (Anticipated)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Paolo Cassano

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder
Keywords
Bipolar, Bipolar Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
All participants will receive five active tPBM treatments and one sham tPBM treatment.
Masking
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.
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Transcranial Phoobiomodulation (tPBM)
Other Intervention Name(s)
Transcranial Light Therapy, Low Level Laser-Light Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Test the effect of tPBM on CBF
Description
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)
Time Frame
Day 1 and Day 5 of tPBM treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paolo Cassano, MD, PhD
Phone
617-643-9622
Email
pcassano@mgh.harvard.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Study Coordinators
Phone
617-724-4539
Email
pbm@mgh.harvard.edu
Facility Information:
Facility Name
Mass General Hospital Navy Yard Building 149
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paolo Cassano, MD, PhD
Phone
617-643-9622
Email
pcassano@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Study Coordinators
Phone
617-724-4539
Email
pbm@mgh.harvard.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Transcranial Photobiomodulation for Executive Function in Bipolar Disorder

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