Status:
ACTIVE_NOT_RECRUITING
Neuromodulation for Enhancement of Emotion Regulation in Bipolar Mood Disorders
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Bipolar Disorder
Eligibility:
All Genders
22-55 years
Phase:
NA
Brief Summary
The investigators are conducting this research study to better understand how individuals with bipolar disorder regulate their emotions, and if transcranial magnetic stimulation (TMS) can help improve...
Detailed Description
The objective of this study protocol is to test whether intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to ventrolateral prefrontal cortex (VLPFC) or inferior parietal lobule (IP...
Eligibility Criteria
Inclusion
- Inclusion Criteria (Healthy Controls)
- Male or female age 18-55
- No history of psychiatric disorder, as assessed using the Mini-International Neuropsychiatric Interview (MINI).
- 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)
- Current or history of psychiatric disorders
- Endorsement of clinical levels of emotion dysregulation
- 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.
- Current pregnancy.
- Medical illness or non-psychiatric medical treatment that would likely interfere with study participation
- Neurologic disorder, prior neurosurgical procedure, prior electroconvulsive therapy (ECT) or TMS, history of seizures or head trauma.
- Presence of metallic implants that would interfere with safety during fMRI scanning.
- Inclusion Criteria (Bipolar Disorder Group)
- Male or female age 18-55
- Diagnosis of Bipolar I Disorder (BD-I), as assessed through MINI.
- 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.
- 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)
- Current symptoms of mania or depression (YMRS score \>12, HAM-D-17 score \>10).
- Medication instability (\<3 months).
- 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.
- Current pregnancy.
- Medical illness or non-psychiatric medical treatment that would likely interfere with study participation
- Neurologic disorder, prior neurosurgical procedure, prior ECT or TMS, history of seizures or head trauma.
- Presence of metallic implants that would interfere with safety during fMRI scanning.
Exclusion
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04284267
Start Date
March 1 2021
End Date
March 1 2026
Last Update
December 22 2025
Active Locations (1)
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1
Martinos Center for Biomedical Imaging
Charlestown, Massachusetts, United States, 02129