Intermittent Theta Burst Stimulation (iTBS) for Emotion Regulation in Bipolar Disorder (NCT06274567)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (12 items).
Location: Martinos Center for Biomedical Imaging — Charlestown, Massachusetts
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- current mania/hypomania assessed by the Young Mania Rating Scale (YMRS \> 12)
- rapid-cycling bipolar illness, defined as \>4 episodes per year, indicating increased risk of switch to mania
- current active suicidality (suicidal ideation with intent or plan), as assessed by a score \>4 on the MADRS item #10
- current substance use disorder for the past 6 months; substance use disorder in remission permitted
- history of psychosis
- dementia or other major neurological disorders, as assessed by a Mini-Mental State Exam (MMSE) score \<24 and Montreal Cognitive Assessment (MOCA) score \<26
- medical illness or non-psychiatric medical treatment that would likely interfere with study participation
- contraindications for magnetic resonance imaging (MRI) or transcranial magnetic stimulation (TMS), including the presence of metallic implants that would interfere with safety (i.e. cardiac pacemaker, metal plates, non-removable body piercings, etc.), history of seizure disorder, history of head trauma
- a clinical course of a neuromodulatory therapy (e.g. transcranial magnetic stimulation, transcranial direct current stimulation, electroconvulsive therapy) within the past 6 months
- current use of benzodiazepines, which can interfere with iTBS stimulation
- current pregnancy, to limit potential risks to an unborn child Other: Given that \>86% of BD patients experience lifetime comorbid anxiety, co-occurring anxiety disorders will be allowable for inclusion, thus providing a more representative sample of bipolar patients who typically present at our Clinics for treatment. Comorbid anxiety disorders are not a criteria for inclusion or exclusion.
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (2 Sites)
- Martinos Center for Biomedical Imaging — Charlestown, Massachusetts
- University of Pennsylvania, Center for Neuromodulation in Depression and Stress — Philadelphia, Pennsylvania
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.