Effects of Theta Burst Stimulation on the Brain, Behavior, and Clinical Symptoms in Adults With Bipolar Disorder

NARecruitingINTERVENTIONAL
Enrollment

134

Participants

Timeline

Start Date

April 6, 2021

Primary Completion Date

November 30, 2025

Study Completion Date

November 30, 2025

Conditions
Bipolar Disorder
Interventions
DEVICE

Continuous Theta Burst Stimulation (cTBS)

cTBS is a brief stimulation of a part of the brain with a magnetic field that passes through the scalp and skull safely. It is FDA-approved as a treatment for psychological conditions including depression; however, this device is not approved for the treatment of adults with Bipolar Disorder I or for use in healthy adults. This research study is using the cTBS off label in all participants (those with and without Bipolar Disorder I) to examine research questions

DEVICE

Sham Continuous Theta Burst Stimulation (Sham cTBS)

Sham cTBS goes through the motions of applying cTBS to the brain but administers very low current so that the participant feels like cTBS is being administered even though the current is too low to stimulate brain cells. Participants will know that one session will be a sham, but they will be blinded to which session is the sham

Trial Locations (1)

15213

RECRUITING

University of Pittsburgh, Pittsburgh

All Listed Sponsors
collaborator

National Institute of Mental Health (NIMH)

NIH

lead

Mary Phillips, MD MD (Cantab)

OTHER