Using brain stimulation to improve emotion regulation in bipolar disorder

Neuromodulation for Enhancement of Emotion Regulation in Bipolar Mood Disorders

This study is testing if a type of brain stimulation can help people with bipolar disorder better manage their emotions.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 22 Years to 55 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Locations: 1 site (Charlestown, Massachusetts)
• Trial ID: NCT04284267 on ClinicalTrials.gov

What this trial studies

This study aims to investigate how individuals with bipolar disorder manage their emotions and whether intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) can enhance their emotion regulation abilities. The research will be conducted in two phases: first, healthy control subjects will undergo fMRI scans to establish a normative baseline for brain function during emotion regulation tasks. In the second phase, patients with bipolar disorder will perform the same tasks, and their brain activity will be compared to the control group to identify specific areas for targeted TMS treatment. The ultimate goal is to develop more effective treatments for emotion regulation in bipolar disorder.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-55 diagnosed with bipolar disorder.

Not a fit: Patients with current or past psychiatric disorders other than bipolar disorder may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved emotional stability and quality of life for patients with bipolar disorder.

How similar studies have performed: Other studies using TMS for mood disorders have shown promising results, suggesting potential for success in this approach.

Eligibility criteria

Inclusion Criteria (Healthy Controls)

1. Male or female age 18-55
2. No history of psychiatric disorder, as assessed using the Mini-International Neuropsychiatric Interview (MINI).
3. Non-Clinical Levels of Emotion Dysregulation, as assessed using the Difficulties in Emotion Regulation Scale (DERS) Non-clinical levels of emotion dysregulation will be defined as a score \< 80 on the DERS.

Exclusion Criteria (Healthy Controls)

1. Current or history of psychiatric disorders
2. Endorsement of clinical levels of emotion dysregulation
3. Current or history of: organic mental disorder; substance abuse within the past 12 months and/or history of substance abuse for \> 1 year; past or current substance dependence (including alcohol); schizophrenia; delusional disorder; and psychotic disorders.
4. Current pregnancy.
5. Medical illness or non-psychiatric medical treatment that would likely interfere with study participation
6. Neurologic disorder, prior neurosurgical procedure, prior electroconvulsive therapy (ECT) or TMS, history of seizures or head trauma.
7. Presence of metallic implants that would interfere with safety during fMRI scanning.

Inclusion Criteria (Bipolar Disorder Group)

1. Male or female age 18-55
2. Diagnosis of Bipolar I Disorder (BD-I), as assessed through MINI.
3. Current mood state euthymic.

   a. Hamilton-Depression Rating Scale (HAM-D-17) and Young Mania Rating Scale (YMRS) will be used to assess current depressive and manic symptoms. Euthymia will be defined as a HAM-D-17 score \<10 and YMRS score \<12.
4. Clinical Levels of Emotion Dysregulation, as assessed using the DERS. Clinical levels of emotion dysregulation will be defined as a score \> 80 on the DERS.

Exclusion Criteria (Bipolar Disorder Group)

1. Current symptoms of mania or depression (YMRS score \>12, HAM-D-17 score \>10).
2. Medication instability (\<3 months).
3. Current or history of: organic mental disorder; substance abuse within the past 12 months and/or history of substance abuse for \> 1 year; past or current substance dependence (including alcohol), verified by urine toxicology screen; schizophrenia; delusional disorder; and psychotic disorders.
4. Current pregnancy.
5. Medical illness or non-psychiatric medical treatment that would likely interfere with study participation
6. Neurologic disorder, prior neurosurgical procedure, prior ECT or TMS, history of seizures or head trauma.
7. Presence of metallic implants that would interfere with safety during fMRI scanning.

Where this trial is running

Charlestown, Massachusetts

• Martinos Center for Biomedical Imaging — Charlestown, Massachusetts, United States (Recruiting)

Study contacts

• Principal investigator: Kristen Ellard, PhD — Massachusetts General Hospital
• Study coordinator: Alexis Worthley, BA

Conditions Bipolar Disorder; Transcranial Magnetic Stimulation; Emotion Regulation