Using brain stimulation to improve emotion regulation in bipolar disorder
Targeting Emotion Regulation in Bipolar Disorder With Intermittent Theta Burst Stimulation: A Mechanistic Study
This study is testing if a special type of brain stimulation can help people with bipolar disorder better manage their emotions during depressive episodes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 136 (estimated) |
| Ages | 24 Years to 65 Years |
| Sex | All |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 2 sites (Charlestown, Massachusetts and 1 other locations) |
| Trial ID | NCT06274567 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effects of intermittent theta-burst transcranial magnetic stimulation (iTBS) on the inferior parietal lobule (IPL) in patients with bipolar disorder. By utilizing functional magnetic resonance imaging (fMRI), the study will identify specific IPL sites for stimulation that are connected to the anterior insula, a key region for emotion regulation. Participants will be randomized to receive either active or sham iTBS over 24 sessions, with assessments of brain function and behavior conducted before and after the intervention. The goal is to determine if targeted stimulation can enhance emotion regulation capabilities in individuals experiencing depressive episodes.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 24-65 with a diagnosis of bipolar I or II disorder currently experiencing a depressive episode.
Not a fit: Patients with current mania, rapid-cycling bipolar disorder, or active suicidality may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved emotion regulation and overall mental health for patients with bipolar disorder.
How similar studies have performed: Other studies have shown promise with similar brain stimulation techniques, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Individuals of all genders 2. ages 24-65 3. 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. 4. Current depressive episode, assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) score ≥20, 5. Ability to provide informed consent and verifiable contact information, including current psychiatric treatment provider 6. Stable medication regimen for at least one month, which must include a mood stabilizer Exclusion Criteria: 1. current mania/hypomania assessed by the Young Mania Rating Scale (YMRS \> 12) 2. rapid-cycling bipolar illness, defined as \>4 episodes per year, indicating increased risk of switch to mania 3. current active suicidality (suicidal ideation with intent or plan), as assessed by a score \>4 on the MADRS item #10 4. current substance use disorder for the past 6 months; substance use disorder in remission permitted 5. history of psychosis 6. dementia or other major neurological disorders, as assessed by a Mini-Mental State Exam (MMSE) score \<24 and Montreal Cognitive Assessment (MOCA) score \<26 7. medical illness or non-psychiatric medical treatment that would likely interfere with study participation 8. 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 9. a clinical course of a neuromodulatory therapy (e.g. transcranial magnetic stimulation, transcranial direct current stimulation, electroconvulsive therapy) within the past 6 months 10. current use of benzodiazepines, which can interfere with iTBS stimulation 11. 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 this trial is running
Charlestown, Massachusetts and 1 other locations
- Martinos Center for Biomedical Imaging — Charlestown, Massachusetts, United States (Recruiting)
- University of Pennsylvania, Center for Neuromodulation in Depression and Stress — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Kristen K Ellard, PhD — Massachusetts General Hospital
- Study coordinator: Kristen K Ellard, PhD
- Email: kellard@mgh.harvard.edu
- Phone: 617-724-3221
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.