Using brain stimulation to improve emotion regulation in bipolar disorder

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.