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

Mass General Brigham

Status

Completed

Conditions

Bipolar Disorder

Transcranial Magnetic Stimulation

Treatments

Device: Transcranial Magnetic Stimulation (TMS)

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03622749

1T32NS100663-01 (U.S. NIH Grant/Contract)

2018P001227

Details and patient eligibility

About

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.

Full 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.

Enrollment

15 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts 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