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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

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
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I do not have any major health or brain conditions.
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I am legally and mentally capable of making my own decisions.
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I have never had brain surgery.
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I am not currently taking any medications for mental health issues.
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I do not have any metal implants in my head or neck, and I am not pregnant.
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I have never had a seizure.
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I have bipolar I disorder and currently feel stable.
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I am between 18 and 50 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had seizures in the past.
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I am currently taking medication for my mental health.
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I have a close family member with psychosis.
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I am currently experiencing a severe mood episode.
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I do not have any metal implants or tattoos near my head or neck.
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I have had brain surgery before.
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I am legally and mentally competent.
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I have metal implants or specific conditions that make me ineligible for magnetic treatments.

Timeline

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

Trial Design

2Treatment groups
Active Control
Group I: PatientsActive Control1 Intervention
Individuals with Bipolar 1 Disorder
Group II: ControlsActive Control1 Intervention
Healthy controls

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.

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,365 Previous Clinical Trials
651,330 Total Patients Enrolled
1 Trials studying Bipolar Disorder
10 Patients Enrolled for Bipolar Disorder
Massachusetts General HospitalLead Sponsor
2,997 Previous Clinical Trials
13,231,465 Total Patients Enrolled
71 Trials studying Bipolar Disorder
18,265 Patients Enrolled for Bipolar Disorder
Kristen K Ellard, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
136 Total Patients Enrolled
1 Trials studying Bipolar Disorder
136 Patients Enrolled for Bipolar Disorder

Media Library

Bipolar Disorder Research Study Groups: Patients, Controls
~2 spots leftby Sep 2025
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