Actively Recruiting
Intermittent Theta Burst Stimulation (iTBS) for Emotion Regulation in Bipolar Disorder
Led by Massachusetts General Hospital · Updated on 2025-04-20
136
Participants Needed
2
Research Sites
236 weeks
Total Duration
On this page
Sponsors
M
Massachusetts General Hospital
Lead Sponsor
U
University of Pennsylvania
Collaborating Sponsor
AI-Summary
What this Trial Is About
The objective of this study protocol is to test whether intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to the inferior parietal lobule (IPL) can strengthen functional connectivity with a key region in emotion regulation (ER) neurocircuitry (anterior insula, AI) and improve performance on ER-related tasks in patients with bipolar disorder. Individual IPL sites for stimulation will be identified through baseline, pre-TMS functional magnetic resonance imaging (fMRI) scans. Patient-specific IPL subregions showing positive functional connectivity with the anterior insula and falling within the patient-specific frontoparietal control network will be used as individualized target sites for TMS stimulation. Patients will be randomized to receive 24 sessions of active versus sham iTBS to patient-specific IPL targets (6 sessions/day, 4 days, 43,200 pulses total). Post-iTBS resting-state and task-based fMRI scans will be acquired 3 days after the final day of iTBS administration (Day 4) following identical procedures as baseline. Effects of iTBS-TMS on ER will be evaluated by comparing pre-TMS versus post-TMS functional connectivity and behavior during performance on ER tasks.
CONDITIONS
Official Title
Intermittent Theta Burst Stimulation (iTBS) for Emotion Regulation in Bipolar Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals of all genders
- Ages 24 to 65 years
- Diagnosis of bipolar I or II disorder based on DSM-5 criteria
- Currently experiencing a depressive episode with a Montgomery-Asberg Depression Rating Scale score of 20 or higher
- Ability to provide informed consent and have verifiable contact information
- Stable medication regimen for at least one month that includes a mood stabilizer
You will not qualify if you...
- Current mania or hypomania with a Young Mania Rating Scale score greater than 12
- Rapid-cycling bipolar disorder with more than 4 episodes per year
- Active suicidal thoughts with intent or plan, indicated by a MADRS item #10 score greater than 4
- Substance use disorder within the past 6 months (remission allowed)
- History of psychosis
- Dementia or major neurological disorder with Mini-Mental State Exam score less than 24 or Montreal Cognitive Assessment score less than 26
- Medical illness or treatment interfering with study participation
- Contraindications for MRI or TMS, including metallic implants or history of seizures or head trauma
- Neuromodulatory therapy in the past 6 months
- Current use of benzodiazepines
- Current pregnancy
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Martinos Center for Biomedical Imaging
Charlestown, Massachusetts, United States, 02129
Actively Recruiting
2
University of Pennsylvania, Center for Neuromodulation in Depression and Stress
Philadelphia, Pennsylvania, United States, 19104-4283(215) 573-4229
Actively Recruiting
Research Team
K
Kristen K Ellard, PhD
CONTACT
C
Christopher Polanco, MS MBA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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