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

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.

Study Overview

• Status: Completed
• Conditions: Transcranial Magnetic Stimulation; Bipolar Disorder
• Intervention / Treatment: Device: Transcranial Magnetic Stimulation (TMS)

Detailed Description

Emotion dysregulation contributes to the development and maintenance of a wide range of psychopathology, but is especially relevant for individuals with bipolar mood disorders (BD). These individuals experience severe and episodic emotion dysregulation associated with maladaptive functioning, interpersonal problems, decreased work productivity, and suicidal ideation and behavior. To date, both pharmacological and psychosocial treatments fail to normalize emotion dysregulation for many bipolar patients. As a consequence, all too many experience poor outcomes. Thus, there is a significant need for new innovative approaches to target and improve emotion dysregulation in bipolar patients. Non-invasive neuromodulation using transcranial magnetic stimulation (TMS) may provide a viable strategy to help improve emotion dysregulation in bipolar mood disorders. As a first step to test this hypothesis, the current proposal seeks to experimentally identify specific neural target sites for improving emotion regulation using TMS. If the investigators can demonstrate target engagement of emotion regulation at the behavioral level using TMS, this will provide an important first step towards examining the potential utility of TMS as a viable strategy to help improve emotion dysregulation in bipolar mood disorders. While this is not a definitive clinical trial, the sham-controlled double-crossover design of this study will provide valuable information for target site selection for the development of TMS as an intervention strategy to improve emotion dysregulation in BD.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02129
      • Martinos Center for Biomedical Imaging

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients; Individuals with Bipolar 1 Disorder	Device: Transcranial Magnetic Stimulation (TMS); Non-Invasive neuromodulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Affective Multisource Interference Task - Reaction Time During Negative Interference Trials	The Affective Multisource Interference Task is a behavioral task measuring the ability to identify an oddball number when overlayed on affective images as a proxy for emotion regulation. Outcome Measure 1: Slope of reaction time during trials with negative valenced stimuli where the oddball number is other than zero and in a location incongruent with the location on the button box	Task administered 10 minutes pre TMS and 5 minutes post TMS
Affective Multisource Interference Task - Reaction Time During Positive Interference Trials	The Affective Multisource Interference Task is a behavioral task measuring the ability to identify an oddball number when overlayed on affective images as a proxy for emotion regulation. Outcome Measure 2: Slope of reaction time during trials with positive valenced stimuli where the oddball number is other than zero and in a location incongruent with the location on the button box	Task administered 10 minutes pre TMS and 5 minutes post TMS
Emotion Conflict Resolution Task - Incongruent Fear Trials Reaction Time	The Emotion Conflict Resolution Task is a behavioral task requiring correct identification of an emotion word overlayed on photographs of facial expressions of emotion. Outcome measure 3: Slope of reaction time during trials when the image is of a fearful facial expression but the word is "Happy" (incongruent)	Task administered 10 minutes pre TMS and 5 minutes post TMS
Emotion Conflict Resolution Task - Incongruent Happy Trials Reaction Time	The Emotion Conflict Resolution Task is a behavioral task requiring correct identification of an emotion word overlayed on photographs of facial expressions of emotion. Outcome measure 4: Slope of reaction time during trials when the image is of a happy facial expression but the word is "Fear" (incongruent)	Task administered 10 minutes pre TMS and 5 minutes post TMS

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
• Investigators: Principal Investigator: Kristen K Ellard, PhD, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): August 1, 2023
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: August 7, 2018
• First Posted (Actual): August 9, 2018

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 28, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bipolar and Related Disorders; Mental Disorders; Mood Disorders; Bipolar Disorder; Therapeutics; Magnetic Field Therapy; Transcranial Magnetic Stimulation
• Other Study ID Numbers: 2018P001227; 1T32NS100663-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No