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Procedure

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)
Awards & highlights

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 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.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Correlated functional magnetic resonance imaging (fMRI) time series (functional connectivity)
Secondary study objectives
Affective Multisource Interference Task
Balloon Analogue Risk Task

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active intermittent theta burst stimulation (iTBS)Experimental Treatment1 Intervention
The Active intermittent theta burst stimulation (iTBS) arm will receive active iTBS applied to the inferior parietal lobule (IPL)
Group II: Sham intermittent theta burst stimulation (iTBS)Placebo Group1 Intervention
The Sham intermittent theta burst stimulation (iTBS) arm will receive sham iTBS applied to the inferior parietal lobule (IPL)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Magnetic Stimulation (TMS)
2018
Completed Phase 4
~550

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
2,993 Previous Clinical Trials
13,230,585 Total Patients Enrolled
70 Trials studying Bipolar Disorder
18,134 Patients Enrolled for Bipolar Disorder
University of PennsylvaniaOTHER
2,053 Previous Clinical Trials
43,012,991 Total Patients Enrolled
5 Trials studying Bipolar Disorder
591 Patients Enrolled for Bipolar Disorder
Kristen K Ellard, PhDPrincipal InvestigatorMassachusetts General Hospital
1 Previous Clinical Trials
15 Total Patients Enrolled
1 Trials studying Bipolar Disorder
15 Patients Enrolled for Bipolar Disorder
~91 spots leftby Aug 2028
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