What side effects are associated with this type of intervention?

The most common side effects of Transcranial Magnetic Stimulation (TMS) include mild device-associated adverse events such as a warm sensation, arm or hand numbness, redness, itching, tingling, muscle spasm, arm pain, shoulder pain, and neck pain. These side effects are generally mild and there have been no serious adverse events reported. However, TMS should not be used in patients with epilepsy due to the theoretical risk of triggering seizures.

What prior FDA approvals exist?

Transcranial Magnetic Stimulation (TMS) has received FDA approval for several indications. Single-pulse TMS has been approved for the acute and prophylactic treatment of migraine, demonstrating significant pain relief and sustained pain-free response. Additionally, repetitive TMS (rTMS) has shown modest effectiveness in treating conditions like chronic tinnitus and depression. These approvals highlight the potential of TMS in modulating brain activity to alleviate symptoms in various neurological and psychiatric disorders.

What other types of research exist?

Promising, novel alternatives to Transcranial Magnetic Stimulation (TMS) include: 1) Transcutaneous Supraorbital Nerve Stimulation, which has shown efficacy in reducing migraine pain intensity with minimal adverse events. 2) Remote Electrical Neuromodulation, which uses a device controlled by a smartphone to apply nonpainful electrical skin stimulation and has demonstrated effectiveness in reducing acute migraine pain. Both methods are noninvasive and have shown positive results in clinical trials.

← Back to Search

Neuromodulation

TMS for Bipolar Mood Disorders

N/A

Waitlist Available

Led By Kristen K Ellard, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

No significant medical or neurological illness

No legal or mental incompetency

Must not have

Patients

History of seizures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline to 15 minutes post-tms stimulation

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

TMS may cause discomfort at the site of application, headache, lightheadedness, or tingling. Rarely it could induce seizures or temporary hearing changes due to the noise during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I do not have any major health or brain conditions.

Select...

I am legally and mentally capable of making my own decisions.

Select...

I have never had brain surgery.

Select...

I am not currently taking any medications for mental health issues.

Select...

I do not have any metal implants in my head or neck, and I am not pregnant.

Select...

I have never had a seizure.

Select...

I have bipolar I disorder and currently feel stable.

Select...

I am between 18 and 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had seizures in the past.

Select...

I am currently taking medication for my mental health.

Select...

I have a close family member with psychosis.

Select...

I am currently experiencing a severe mood episode.

Select...

I do not have any metal implants or tattoos near my head or neck.

Select...

I have had brain surgery before.

Select...

I am legally and mentally competent.

Select...

I have metal implants or specific conditions that make me ineligible for magnetic treatments.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline to 15 minutes post-tms stimulation

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline to 15 minutes post-tms stimulation

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to 15 minutes post-tms stimulation for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change Cognitive Reappraisal Task

Change Emotion Conflict Resolution Task

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: PatientsActive Control1 Intervention

Individuals with Bipolar 1 Disorder

Group II: ControlsActive Control1 Intervention

Healthy controls

0 / 17Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Transcranial Magnetic Stimulation (TMS) works by using magnetic fields to induce electrical currents in specific areas of the brain, particularly targeting the prefrontal cortex. This stimulation can modulate neural activity, leading to changes in brain function that are associated with improved mood and emotion regulation. For patients, understanding these mechanisms is crucial as it highlights how TMS can potentially alleviate symptoms of mood disorders, such as depression and bipolar disorder, by directly influencing brain regions involved in emotion processing and regulation.