N/A N=19 Health Services Research

Pilot Study of Neuromodulation for Enhancement of Emotion Regulation in Bipolar Mood Disorders

Bipolar Disorder · Transcranial Magnetic Stimulation

Bottom Line

View on ClinicalTrials.gov: NCT03622749 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2026

Primary outcome: Primary: Affective Multisource Interference Task - Reaction Time During Negative Interference Trials — 733.45; 720.58; 723.09; 698.17 Reaction Time (ms) — p=<0.0001

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Transcranial Magnetic Stimulation (TMS) (Device)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Aug 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Affective Multisource Interference Task - Reaction Time During Negative Interference Trials	733.45; 720.58; 723.09; 698.17; 734.55; 705.65	<0.0001 sig
PRIMARY Affective Multisource Interference Task - Reaction Time During Positive Interference Trials	726.68; 735.26; 733.87; 696.09; 730.17; 703.95	0.0002 sig
PRIMARY Emotion Conflict Resolution Task - Incongruent Fear Trials Reaction Time	699.66; 704.05; 702.21; 684.23; 699.22; 678.50	0.06
PRIMARY Emotion Conflict Resolution Task - Incongruent Happy Trials Reaction Time	680.70; 677.77; 685.39; 675.23; 685.34; 674.94	0.43

Summary

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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
Active use of neuropsychoactive medications
Legal or mental incompetency
Intellectual disability
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
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
Pregnant women

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03622749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.