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Procedure

Active intermittent theta burst stimulation (iTBS) 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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Correlated functional magnetic resonance imaging (fMRI) time series (functional connectivity)

Secondary outcome measures

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

~570

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,936 Previous Clinical Trials

13,198,585 Total Patients Enrolled

68 Trials studying Bipolar Disorder

15,388 Patients Enrolled for Bipolar Disorder

University of PennsylvaniaOTHER

2,005 Previous Clinical Trials

42,882,901 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals enroll themselves in this medical research study?

"Individuals with bipolar disorder aged between 24 and 65 are sought for this study. Approximately 136 participants will be selected."

Answered by AI

Are there any vacancies available for patients to participate in this trial?

"According to information from clinicaltrials.gov, recruitment for this trial is presently closed. Although initially posted on April 1st, 2024 and last revised on February 21st, 2024, patient enrollment is not ongoing. Despite this, there are currently 170 alternative trials actively enrolling participants."

Answered by AI