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

Primary Purpose

Bipolar Disorder, Transcranial Magnetic Stimulation

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Magnetic Stimulation (TMS)
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Bipolar Disorder

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Martinos Center for Biomedical Imaging

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Patients

Controls

Arm Description

Individuals with Bipolar 1 Disorder

Healthy controls

Outcomes

Primary Outcome Measures

Change Emotion Conflict Resolution Task
Slope of reaction time (milliseconds)
Change Cognitive Reappraisal Task
Distress rating (scale 1- 4)

Secondary Outcome Measures

Full Information

First Posted
July 11, 2018
Last Updated
October 5, 2023
Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
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1. Study Identification

Unique Protocol Identification Number
NCT03622749
Brief Title
Pilot Study of Neuromodulation for Enhancement of Emotion Regulation in Bipolar Mood Disorders
Official Title
Pilot Study of Neuromodulation for Enhancement of Emotion Regulation in Bipolar Mood Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Active Comparator
Arm Description
Individuals with Bipolar 1 Disorder
Arm Title
Controls
Arm Type
No Intervention
Arm Description
Healthy controls
Intervention Type
Device
Intervention Name(s)
Transcranial Magnetic Stimulation (TMS)
Intervention Description
Non-Invasive neuromodulation
Primary Outcome Measure Information:
Title
Change Emotion Conflict Resolution Task
Description
Slope of reaction time (milliseconds)
Time Frame
Change from baseline to 15 minutes post-TMS stimulation
Title
Change Cognitive Reappraisal Task
Description
Distress rating (scale 1- 4)
Time Frame
Change from baseline to 15 minutes post-TMS stimulation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristen K Ellard, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Martinos Center for Biomedical Imaging
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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