TMS for Bipolar Mood Disorders

Overseen By Blake Andreou, BA

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must be taking: Psychiatric medications

Must not be taking: Neuropsychoactive medications

Disqualifiers: Substance use, Seizures, Neurological illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 15 minutes per session

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if using magnetic fields to stimulate brain cells can help people with bipolar disorder manage their emotions better. Current treatments often don't work well for these patients, so this new approach aims to improve their emotional control by targeting specific brain areas.

Research Team

Kristen K Ellard, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for adults aged 18-50 with bipolar I disorder who are not in a current mood episode and have been on stable psychiatric medication for at least one month. Participants should not have metal implants sensitive to magnets near their head or neck, no history of seizures, neurosurgery, ECT or TMS treatment within three months, and no active substance use disorders.

Inclusion Criteria

Without major psychiatric illness

No first-degree relative with psychosis

I haven't had ECT or TMS treatments in the last 3 months.

Exclusion Criteria

History of major psychiatric illness, including psychosis

I have had seizures in the past.

I am currently taking medication for my mental health.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial magnetic stimulation (TMS) to improve emotion regulation

15 minutes per session

Multiple sessions (exact number not specified)

Follow-up

Participants are monitored for changes in emotion regulation tasks post-TMS

15 minutes post-TMS

Treatment Details

Interventions

• TMS

Trial Overview The study tests whether transcranial magnetic stimulation (TMS), a non-invasive brain stimulation technique, can improve emotion regulation in individuals with bipolar disorder. It aims to understand the potential benefits of TMS as an adjunct therapy for mood stabilization.

Participant Groups

Group I: Patients Active Control 1 Intervention

Individuals with Bipolar 1 Disorder

Group II: Controls Active Control 1 Intervention

Healthy controls

TMS is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Transcranial Magnetic Stimulation for:

• Depression
• Anxiety disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in European Union as Transcranial Magnetic Stimulation for:

• Depression
• Anxiety disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Approved in Canada as Transcranial Magnetic Stimulation for:

• Depression
• Anxiety disorders
• Post-traumatic stress disorder (PTSD)
• Obsessive-compulsive disorder (OCD)

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials

1,403

Recruited

655,000+