iTBS-TMS for Bipolar Disorder

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

Current depressive episode assessed using the Montgomery-Asberg Depression Rating Scale (MADRS) score ≥20

Stable medication regimen for at least one month, which must include a mood stabilizer

Must not have

Current use of benzodiazepines which can interfere with iTBS stimulation

Dementia or other major neurological disorders as assessed by a Mini-Mental State Exam (MMSE) score <24 and Montreal Cognitive Assessment (MOCA) score <26

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1-3 days post 4-day intervention (up to 4 weeks post baseline)

Summary

This trial aims to study whether a type of brain stimulation called intermittent theta-burst transcranial magnetic stimulation (iTBS-TMS) to a specific part of the brain can improve connectivity with another brain

Who is the study for?

This trial is for individuals with bipolar disorder. Participants will be selected based on their brain imaging scans and must have a specific connection in the brain that can be targeted by the treatment. They should be able to complete multiple sessions over several days.

What is being tested?

The study tests if iTBS-TMS, a non-invasive brain stimulation technique, can improve emotion regulation in bipolar patients by targeting a specific brain area identified through fMRI scans. Patients receive either real or sham TMS over four days to see if it affects their emotional control.

What are the potential side effects?

TMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures (very rare). Sham TMS has no active components but may produce similar sensations due to placebo effect.

Eligibility Criteria

Inclusion Criteria

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

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I am currently experiencing a significant depressive episode.

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I have been on a stable medication regimen including a mood stabilizer for at least one month.

Exclusion Criteria

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

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I am currently taking benzodiazepines.

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My mental function tests show I don't have severe memory or thinking problems.

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I don't have metal implants, a history of seizures, or serious head injuries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1-3 days post 4-day intervention (up to 4 weeks post baseline)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1-3 days post 4-day intervention (up to 4 weeks post baseline)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1-3 days post 4-day intervention (up to 4 weeks post baseline) for reporting.