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

NCT03622749 | Completed Results DMC FDA Device

• 2 other identifiers: 2018P0012271T32NS100663-01
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Bipolar Disorder; Transcranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Patients

ACTIVE COMPARATOR

Individuals with Bipolar 1 Disorder

Device: Transcranial Magnetic Stimulation (TMS)

Interventions

Transcranial Magnetic Stimulation (TMS) DEVICE

Non-Invasive neuromodulation

Patients

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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)

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Martinos Center for Biomedical Imaging

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Limitations and Caveats

The current study is intended to collect pilot data and therefore uses a small sample, which limits the interpretability of the results. All results from this study should thus be interpreted with caution.

Results Point of Contact

• Title: Kristen K. Ellard, PhD
• Organization: Massachusetts General Hospital

kellard@mgh.harvard.edu

617-724-3221

Study Officials

• Kristen K Ellard, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participants are blinded to whether they received active versus sham (placebo) TMS.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor in Psychology

Study Record Dates

• First Submitted: July 11, 2018
• First Posted: August 9, 2018
• Study Start: March 1, 2019
• Primary Completion: August 1, 2023
• Study Completion: January 1, 2025
• Last Updated: March 3, 2026
• Results First Posted: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)