Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Recruiting NA study of Bipolar Disorder, sponsored by Massachusetts General Hospital.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Primary outcome will be changes in the correlated time series between brain regions (inferior parietal lobule and anterior insula) from baseline to post intervention
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 |
What NCT06274567 shows while recruiting
NCT06274567 is an interventional study that assigns participants to a tested intervention. The registered 136 participants enrollment target is mid-sized for trials with a published cap, below the 332-participant average among 162 other Bipolar Disorder trials with a reported enrollment target (59% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Bipolar Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06274567's enrollment target sits among peer trials
136 51st of 162 higher than 112 of 162 other Bipolar Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Bipolar Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Taking Action for College Students
RECRUITING · NA
-
Getting Out of the House: Using Behavioral Activation to Increase Community Participation
RECRUITING · NA
-
Healthy Lifestyles in Bipolar Disorder: Bay Area Study
RECRUITING · NA
-
A Future Thinking Intervention for Comorbid Tobacco Use Disorder and Bipolar Disorder
RECRUITING · NA
-
Use of Ketosis in Modulating Metabolic Pathways in Bipolar Disorder
RECRUITING · NA
-
Transcranial Direct Current Stimulation (tDCS) Neuromodulation of Executive Function Across Neuropsychiatric Populations
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT01555892 · 136 participants · Phase 1
Cytotoxic T-Lymphocytes for EBV-positive Lymphoma, GRALE
- NCT03216525 · 136 participants · Phase 3
Alvimopan Versus Placebo in Patients Undergoing Radical Cystectomy on an Enhanced Recovery Protocol
- NCT04476901 · 136 participants · Phase 2
Administration of Allogeneic-MSC in Patients With Non-Ischemic Dilated Cardiomyopathy
- NCT04603898 · 136 participants · NA
Oxalate Formation From Ascorbic Acid
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI