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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 15 minutes post-tms stimulation
Awards & highlights
Study Summary
This trial is testing if TMS, a technique that uses magnetic fields to stimulate the brain, can help people with bipolar disorder regulate their emotions better.
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.Check my eligibility
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.See study design
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 belowSelect...
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.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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
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Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,339 Previous Clinical Trials
649,291 Total Patients Enrolled
Massachusetts General HospitalLead Sponsor
2,928 Previous Clinical Trials
13,198,340 Total Patients Enrolled
Kristen K Ellard, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
136 Total Patients Enrolled
Media Library
Research Study Groups:
This trial has the following groups:- Group 1: Patients
- Group 2: Controls
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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