Tests brain stimulation for emotion control in bipolar disorder
Tests magnetic brain stimulation against sham in adults with bipolar disorder.
Plain-language title generated from the registry record
Registry title: Intermittent Theta Burst Stimulation (iTBS) for Emotion Regulation in Bipolar Disorder
Key facts
- Where
- Charlestown and Philadelphia, United StatesSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 24 and 65 years old?
Source: NCT06274567, who can take part
Where in United States
- Martinos Center for Biomedical ImagingCharlestown, United StatesTaking people
- University of Pennsylvania, Center for Neuromodulation in Depression and StressPhiladelphia, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Massachusetts General Hospital
- Trial code
- NCT06274567
- Record updated
- 16 July 2026
- Original description
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.Read full original descriptionShow less
Targeting Emotion Regulation in Bipolar Disorder With Intermittent Theta Burst Stimulation: A Mechanistic Study
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.
Inclusion: 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.
Exclusion: a clinical course of a neuromodulatory therapy (e.g. transcranial magnetic stimulation, transcranial direct current stimulation, electroconvulsive therapy) within the past 6 months; rapid-cycling bipolar illness, defined as >4 episodes per year, indicating increased risk of switch to mania; 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; 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; current mania/hypomania assessed by the Young Mania Rating Scale (YMRS > 12); current active suicidality (suicidal ideation with intent or plan), as assessed by a score >4 on the MADRS item #10; current use of benzodiazepines, which can interfere with iTBS stimulation.