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NCT06274567 · ClinicalTrials.gov registry record · NA
Intermittent Theta Burst Stimulation (iTBS) for Emotion Regulation in Bipolar Disorder
A NA study of Bipolar Disorder, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- NA
- Development phase
- 136
- Enrollment target
- 2
- Study locations
NCT06274567 is a NA study of Bipolar Disorder that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 136 participants, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (59% lower). The trial reports 2 study locations across 2 states.
The verdict
NCT06274567, a NA study of Bipolar Disorder, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- NA
- Development phase
- 136 participants
- Enrollment target
- 2
- Study locations
Study 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.
Conditions Studied
Interventions
- DEVICE Transcranial Magnetic Stimulation (TMS)
- DEVICE Sham (placebo) TMS
Study Locations (2)
Massachusetts
- Martinos Center for Biomedical Imaging - Charlestown
Pennsylvania
- University of Pennsylvania, Center for Neuromodulation in Depression and Stress - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 136 participants |
| Start Date | 2024-09-20 |
| Est. Completion | 2029-03-31 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06274567
The ClinicalTrials.gov registry entry for NCT06274567 describes a study currently listed as recruiting, categorized as NA. The registered enrollment target is 136 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (59% lower). The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Bipolar Disorder appearing as the primary indexed condition, and to 2 interventions - of which Transcranial Magnetic Stimulation (TMS) is the first listed.
NCT06274567 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Massachusetts, Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06274567 about?
NCT06274567 is a clinical study titled "Intermittent Theta Burst Stimulation (iTBS) for Emotion Regulation in Bipolar Disorder". 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 per...
What is the current status of trial NCT06274567?
This trial is currently recruiting. It is a NA study. The enrollment target is 136 participants. The study started on 2024-09-20. Estimated completion is 2029-03-31.
What conditions does trial NCT06274567 study?
This clinical trial studies the following conditions: Bipolar Disorder.
What interventions are being tested in trial NCT06274567?
The interventions under investigation include: Transcranial Magnetic Stimulation (TMS) (DEVICE), Sham (placebo) TMS (DEVICE).
Who is sponsoring clinical trial NCT06274567?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06274567 being conducted?
This trial has 2 study locations across Massachusetts, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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