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NCT06274567Not yet recruiting

Intermittent Theta Burst Stimulation (iTBS) for Emotion Regulation in Bipolar Disorder

Targeting Emotion Regulation in Bipolar Disorder With Intermittent Theta Burst Stimulation: A Mechanistic Study
Massachusetts General HospitalClinicalTrials.govdeviceDevice trial
Verified
Study focus
Disease/Condition
Bipolar Disorder
Drug/Device/Intervention
Transcranial Magnetic Stimulation (TMS)
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Massachusetts General Hospital
Location
Charlestown, United States of America
Timeline & enrollment
Phase
N/A
Start date
Apr 01, 2024
End date
Mar 31, 2029
Enrollment
136 participants
Primary outcome

Correlated functional magnetic resonance imaging (fMRI) time series (functional connectivity)

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.

ICD-10 classifications
Bipolar affective disorderBipolar affective disorder, unspecifiedOther bipolar affective disordersBipolar affective disorder, currently in remissionBipolar affective disorder, current episode mixed
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06274567
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06274567 through Pure Global AI's free database. This phase not specified trial is sponsored by Massachusetts General Hospital and is currently Not yet recruiting. The study focuses on Bipolar Disorder. Target enrollment is 136 participants.

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