Neuromodulation for Enhancement of Emotion Regulation in Bipolar Mood Disorders

NCT04284267 | Completed DMC FDA Device

• 1 other identifier: 2020P000120
• Study Type: interventional
• Target: 56
• 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 transcranial magnetic stimulation (TMS) can help improve emotion regulation for individuals with bipolar mood disorders.

Conditions

Bipolar Disorder

Keywords

Transcranial Magnetic Stimulation; Emotion Regulation

Outcome Measures

Primary Outcomes (2)

• Multisource Interference Task with International Affective Pictures Set (MSIT-IAPS)

  The MSIT-IAPS task is a well-validated fMRI task designed to assess the effects of emotional distractors on cognitive control. During each trial, a three-digit number is presented. Each set contains two identical distractor numbers and a target number that differed from the distractors. Participants report via a button press the identity of the target number that differs from the two distractor numbers. Noninterference (control) trials: distractor numbers are always zeros, and the identity of the target number always corresponds to its position on the button response pad (100, 020, 003). Interference trials: distractor numbers are always numbers other than 0, and the identity of the target number is always incongruent with its position on the button response pad (e.g. 211, 232, 331, etc.). Each trial of the MSIT is overlaid on a negative, positive, or neutral IAPS image. Reaction time (ms) and accuracy (% correct) is calculated for each trial.

  Change from Baseline to Post-TMS Stimulation (30 min-1 hour)

• Emotion Conflict Resolution Task

  The ECR task is a well-validated task designed to assess the effects of emotional conflict that arises from the incompatibility between task-relevant and task-irrelevant emotional dimensions of a stimulus. Faces with fearful and happy expressions are presented with the words "happy" or "fear" written across them. Words are either congruent (e.g. "happy" written across an image with a happy expression) or incongruent (e.g. "happy" written across an image with a fearful expression). Subjects are asked to identify the emotional expression of the face while ignoring the word. Trials are analyzed with regard to immediately preceding trials: incongruent trials preceded by congruent trials (CI trials) measure emotion conflict, and incongruent trials preceded by incongruent trials (II trials) measure resolution of emotion conflict. Reaction time (ms) and accuracy (% correct) is calculated for each trial.

  Change from Baseline to Post-TMS Stimulation (30 min-1 hour)

Secondary Outcomes (5)

• MSIT-IAPS Task-induced blood oxygen level dependent (BOLD) signal

  Change from Baseline to Post-TMS Stimulation (30 min-1 hour)

• MSIT-IAPS Task-induced blood oxygen level dependent (BOLD) signal functional connectivity

  Change from Baseline to Post-TMS Stimulation (30 min-1 hour)

• ECR Task-induced blood oxygen level dependent (BOLD) signal

  Change from Baseline to Post-TMS Stimulation (30 min-1 hour)

• ECR Task-induced blood oxygen level dependent (BOLD) signal functional connectivity

  Change from Baseline to Post-TMS Stimulation (30 min-1 hour)

• Skin Conductance Response

  Change from Baseline to Post-TMS Stimulation (30 min-1 hour)

Study Arms (2)

Healthy Control

NO INTERVENTION

This group consists of individuals with no psychiatric diagnosis.

Bipolar Group

EXPERIMENTAL

This group consists of individuals with a diagnosis of bipolar disorder who have been randomized to receive high-dose TMS (i.e., 1800 pulses) and sham TMS.

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

TMS is a non-invasive tool for modulating patterns of brain activation and circuit connectivity. It uses electromagnetic pulses to induce electric currents over the cortex that serve to depolarize or hyperpolarize neurons, thereby changing patterns of synaptic activity. This study will use intermittent theta burst stimulation (iTBS), an efficient TMS protocol that uses high frequency (50Hz) triplets of TMS given every 200 milliseconds (i.e. at 5 Hz).

Also known as: TMS

Bipolar Group

Eligibility Criteria

• Age: 22 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male or female age 18-55
• No history of psychiatric disorder, as assessed using the Mini-International Neuropsychiatric Interview (MINI).
• Non-Clinical Levels of Emotion Dysregulation, as assessed using the Difficulties in Emotion Regulation Scale (DERS) Non-clinical levels of emotion dysregulation will be defined as a score \< 80 on the DERS.

You may not qualify if:

• Current or history of psychiatric disorders
• Endorsement of clinical levels of emotion dysregulation
• Current or history of: organic mental disorder; substance abuse within the past 12 months and/or history of substance abuse for \> 1 year; past or current substance dependence (including alcohol); schizophrenia; delusional disorder; and psychotic disorders.
• Current pregnancy.
• Medical illness or non-psychiatric medical treatment that would likely interfere with study participation
• Neurologic disorder, prior neurosurgical procedure, prior electroconvulsive therapy (ECT) or TMS, history of seizures or head trauma.
• Presence of metallic implants that would interfere with safety during fMRI scanning.
• Male or female age 18-55
• Diagnosis of Bipolar I Disorder (BD-I), as assessed through MINI.
• Current mood state euthymic.
• a. Hamilton-Depression Rating Scale (HAM-D-17) and Young Mania Rating Scale (YMRS) will be used to assess current depressive and manic symptoms. Euthymia will be defined as a HAM-D-17 score \<10 and YMRS score \<12.
• Clinical Levels of Emotion Dysregulation, as assessed using the DERS. Clinical levels of emotion dysregulation will be defined as a score \> 80 on the DERS.
• Current symptoms of mania or depression (YMRS score \>12, HAM-D-17 score \>10).
• Medication instability (\<3 months).
• Current or history of: organic mental disorder; substance abuse within the past 12 months and/or history of substance abuse for \> 1 year; past or current substance dependence (including alcohol), verified by urine toxicology screen; schizophrenia; delusional disorder; and psychotic disorders.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Martinos Center for Biomedical Imaging

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Emotional Regulation

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders; Self-Control; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Kristen Ellard, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Masking will be implemented using a active-placebo TMS coil.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Dimensional Neuroimaging Research

Model Details: There will be a healthy control group and a bipolar disorder group. The bipolar disorder group will then be randomized to one of three conditions.

Study Record Dates

• First Submitted: February 20, 2020
• First Posted: February 25, 2020
• Study Start: March 1, 2021
• Primary Completion: October 30, 2025
• Study Completion: March 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Locations

US (1)