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

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Bipolar Disorder

In brief

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.

Key facts

Study ID

NCT06274567

Run by

Massachusetts General Hospital

People needed

136

Starts

2024-09-20

Expected to finish

2029-03-31

Last updated by the study team

2026-07-16

Who can join

Age: 24 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Martinos Center for Biomedical Imaging — Charlestown, Massachusetts, United States (enrolling)
• University of Pennsylvania, Center for Neuromodulation in Depression and Stress — Philadelphia, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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