NCT03622749Completed
Pilot Study of Neuromodulation for Enhancement of Emotion Regulation in Bipolar Mood Disorders
Source: ClinicalTrials.gov · Last updated 3 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 19 (actual)
- First submitted
- 11 Jul 2018
- Start date
- 1 Mar 2019
- Primary completion date
- 1 Aug 2023
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Bipolar disorder
- NCT number
- NCT03622749
What you commit to
- Study type: Interventional
- Participants enrolled: 19
- From 1 Mar 2019 to the primary completion date, 1 Aug 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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:
- Active use of neuropsychoactive medications
- Prior neurosurgical procedure
- Individuals 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
Other illness
- History of major psychiatric illness, including psychosis
- Substance use disorder (abuse or dependence) with active use within the last 3 months
- Significant medical or neurological illness
- History of seizures
- History of ECT treatment or clinical TMS within the past three months
- Implanted cardiac pacemakers
Other
- Has a first-degree relative with psychosis
- Legal or mental incompetency
- Intellectual disability
- Pregnant women
Who the study is looking for
- 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
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Martinos Center for Biomedical Imaging Coordinator of this site? Confirm its status | Charlestown | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.