15 Participants Needed

TMS for Bipolar Mood Disorders

AW
BA
Overseen ByBlake Andreou, BA
Age: 18 - 65
Sex: Any
Trial Phase: Academic
Sponsor: Massachusetts General Hospital
Must be taking: Psychiatric medications
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether transcranial magnetic stimulation (TMS) can help individuals with bipolar disorder manage their emotions more effectively. Researchers aim to determine if TMS, a non-invasive technique using magnetic fields to stimulate the brain, can enhance mood regulation in those with bipolar disorder. The trial includes two groups: individuals diagnosed with bipolar I disorder who have remained stable on psychiatric medication for at least a month, and healthy individuals without major psychiatric illnesses. Participants must not have recently changed psychiatric medications or possess certain metal implants in their head or neck. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new methods for managing bipolar disorder.

What prior data suggests that this technique is safe for individuals with bipolar disorder?

Research has shown that transcranial magnetic stimulation (TMS) is generally safe for individuals with mood disorders, such as bipolar disorder. Studies have found that most people tolerate TMS well, experiencing no major issues. Some may feel slight scalp discomfort or a mild headache, but serious side effects are rare.

The FDA has approved TMS for treating major depression, and researchers are also exploring its use for bipolar disorder. Experts believe it could be helpful and safe for individuals with bipolar disorder as well. Overall, TMS has been tested in numerous studies with positive safety results, making it a promising treatment option for consideration.12345

Why are researchers excited about this trial?

Transcranial Magnetic Stimulation (TMS) is unique because it offers a non-invasive way to potentially stabilize mood in individuals with Bipolar 1 Disorder. Unlike traditional treatments such as mood stabilizers and antipsychotic medications, TMS uses magnetic fields to stimulate specific areas of the brain linked to mood regulation. Researchers are excited about TMS because it could provide a faster onset of relief with fewer side effects compared to medication, which often requires weeks to take effect and can have significant side effects. This innovative approach targets the brain directly, which may lead to more precise and rapid improvements in mood symptoms.

What evidence suggests that TMS is effective for improving emotion regulation in individuals with bipolar disorder?

Research has shown that transcranial magnetic stimulation (TMS) could help treat bipolar disorder, particularly during depressive episodes. One study found that 87.1% of patients with bipolar depression responded positively to TMS, and 74.2% experienced significant symptom improvement, reaching remission. TMS is already approved for major depression and is gaining attention for its potential benefits in bipolar disorder. Although some studies have mixed results, many patients experience positive outcomes, and the treatment is popular due to its non-invasive nature. This trial will administer TMS to participants to evaluate its effectiveness specifically for bipolar mood disorders.12467

Who Is on the Research Team?

KK

Kristen K Ellard, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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.
See 13 more

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.
See 14 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Active Control
Group I: PatientsActive Control1 Intervention
Group II: ControlsActive Control1 Intervention

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

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Approved in United States as Transcranial Magnetic Stimulation for:
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Approved in European Union as Transcranial Magnetic Stimulation for:
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Approved in Canada as Transcranial Magnetic Stimulation for:

Find a Clinic Near You

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+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/33949063/
Repetitive transcranial magnetic stimulation (rTMS) in ...Most studies included participants diagnosed with a bipolar depressive episode (N = 24), have yielded mixed findings, and have yet to reach a consensus on the ...
Efficacy, effectiveness and safety of transcranial magnetic ...Repetitive transcranial magnetic stimulation (rTMS) is FDA-approved for major depression and recently received breakthrough status for bipolar ...
A Pilot Study on Repetitive Transcranial Magnetic ...This is a pilot project to study if repetitive Transcranial Magnetic Stimulation (rTMS) will benefit patients with bipolar depression safely. Based on published ...
Repetitive transcranial magnetic stimulation for bipolar ...The outcomes were treatment response (primary), improvement in depressive symptoms, remission rate, all-cause discontinuation, and mania ...
A Pilot Study of High-Frequency Transcranial Magnetic ...In this study of patients with bipolar depression, 87.1% reached response and 74.2% reached remission with 6 weeks of rTMS.
Repetitive Transcranial Magnetic Stimulation (rTMS) for ...The primary objective of this study is to examine the safety and efficacy of rTMS in the management of treatment-resistant bipolar depression.
Clinical applications of transcranial magnetic stimulation in ...Cognitive outcomes of TMS treatment in bipolar depression: Safety data from a randomized controlled trial. Journal of Affective Disorders, 235, 20–26.
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