Pilot Study of Neuromodulation for Enhancement of Emotion Regulation in Bipolar Mood Disorders
Completed · Not applicable · Has a placebo group
Conditions studied: Bipolar Disorder, Transcranial Magnetic Stimulation
In brief
The investigators are conducting this research study to better understand how individuals with bipolar disorder regulate their emotions, and if the study can use a technique called "transcranial magnetic stimulation" or TMS to help improve emotion regulation for individuals with bipolar disorder.
Key facts
- Study ID
- NCT03622749
- Run by
- Massachusetts General Hospital
- People needed
- 19
- Starts
- 2019-03-01
- Expected to finish
- 2025-01-01
- Last updated by the study team
- 2026-03-03
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Patients
- Men and women
- Ages 18-50 years
- Patients diagnosed with bipolar I disorder (BD-I), current mood state euthymic.
- On a stable psychiatric medication regimen for at least a month prior to and during study participation
- Healthy Controls:
- Men and women
- Ages 18-50 years
- Without major psychiatric illness
You may not qualify if…
- Patients
- Any change in psychiatric medications within a month prior to and during study participation
- Legal or mental incompetency
- Intellectual disability
- Current manic (YMRS > 12) or severe depressive episode (HAM-D-17 > 5)
- Substance use disorder (abuse or dependence) with active use within the last 3 months
- Significant medical or neurological illness
- Prior neurosurgical procedure
- History of seizures
- History of ECT treatment or clinical TMS within the past three months
- Implanted cardiac pacemakers
- Patients who have conductive, ferromagnetic or other magnetic-sensitive metals implanted in their head or neck, or are non-removable and within 30 cm of the treatment coil. These include:
- Aneurysm clips or coils
- Carotid or cerebral stents
- Metallic devices implanted in the head (e.g. Implanted pacemaker, medication pump, vagal stimulator, deep brain stimulator, TENS unit, or ventriculo-peritoneal shunt)
- Magnetically active dental implants
- Cochlear/otologic implants
- CSF shunts
- Ferromagnetic ocular implants
- Pellets, bullets, fragments less than 30 cm from the coil
- Facial tattoos with metallic ink, permanent makeup less than 30 cm from the coil
- Pregnant women
- Healthy Controls:
- History of major psychiatric illness, including psychosis
- Has a first-degree relative with psychosis
Where it is running
- Martinos Center for Biomedical Imaging — Charlestown, Massachusetts, United States
Full record on ClinicalTrials.gov
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