Targeting Emotion Regulation in Bipolar Disorder With Intermittent Theta Burst Stimulation: A Mechanistic Study

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 24
Maximum Age: 65
Healthy Volunteers: f
View:

• Individuals of all genders

• ages 24-65

• Diagnostic Statistical Manual (DSM-5) defined diagnosis of bipolar I or II disorder (BD); assessed using the Mini-International Neuropsychiatric Interview (M.I.N.I.) version 7.0.2.

• Current depressive episode, assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) score ≥20,

• Ability to provide informed consent and verifiable contact information, including current psychiatric treatment provider

• Stable medication regimen for at least one month, which must include a mood stabilizer

Locations
United States
Massachusetts
Martinos Center for Biomedical Imaging
RECRUITING
Charlestown
Pennsylvania
University of Pennsylvania, Center for Neuromodulation in Depression and Stress
RECRUITING
Philadelphia
Contact Information
Primary
Kristen K Ellard, PhD
kellard@mgh.harvard.edu
617-724-3221
Backup
Christopher Polanco, MS MBA
cjpolanco@mgh.harvard.edu
(617) 643-2776
Time Frame
Start Date: 2024-09-20
Estimated Completion Date: 2029-03-31
Participants
Target number of participants: 136
Treatments
Experimental: Active intermittent theta burst stimulation (iTBS)
The Active intermittent theta burst stimulation (iTBS) arm will receive active iTBS applied to the inferior parietal lobule (IPL)
Placebo_comparator: Sham intermittent theta burst stimulation (iTBS)
The Sham intermittent theta burst stimulation (iTBS) arm will receive sham iTBS applied to the inferior parietal lobule (IPL)
Related Therapeutic Areas
Sponsors
Leads: Massachusetts General Hospital
Collaborators: University of Pennsylvania

This content was sourced from clinicaltrials.gov