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Neuromodulation

Transcranial Magnetic Stimulation for Bipolar Disorder

N/A
Recruiting
Led By Kristen 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
Male or female age 18-55
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to post-tms stimulation (30 min-1 hour)
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if transcranial magnetic stimulation can help people with bipolar disorder regulate their emotions better.

Who is the study for?
This trial is for adults aged 18-55 with bipolar mood disorders who struggle to regulate their emotions. Healthy individuals without psychiatric conditions, as confirmed by an interview, and who score below 80 on the Emotion Regulation Scale can also participate.
What is being tested?
The study is testing whether Transcranial Magnetic Stimulation (TMS), a non-invasive procedure that uses magnetic fields to stimulate nerve cells in the brain, can improve emotion regulation in people with bipolar disorder.
What are the potential side effects?
TMS may cause discomfort at the site of stimulation, headache, lightheadedness, or tingling. It's generally considered safe but could rarely trigger seizures or affect mood negatively.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 55 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to post-tms stimulation (30 min-1 hour)
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline to post-tms stimulation (30 min-1 hour) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Emotion Conflict Resolution Task
Multisource Interference Task with International Affective Pictures Set (MSIT-IAPS)
Secondary study objectives
ECR Task-induced blood oxygen level dependent (BOLD) signal
ECR Task-induced blood oxygen level dependent (BOLD) signal functional connectivity
MSIT-IAPS Task-induced blood oxygen level dependent (BOLD) signal
+2 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Bipolar GroupExperimental Treatment1 Intervention
This group consists of individuals with a diagnosis of bipolar disorder who have been randomized to receive high-dose TMS (i.e., 1800 pulses) and sham TMS.
Group II: Healthy ControlActive Control1 Intervention
This group consists of individuals with no psychiatric diagnosis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transcranial Magnetic Stimulation
2017
Completed Phase 4
~730

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor
3,015 Previous Clinical Trials
13,309,300 Total Patients Enrolled
72 Trials studying Bipolar Disorder
18,290 Patients Enrolled for Bipolar Disorder
Kristen Ellard, PhDPrincipal InvestigatorMassachusetts General Hospital

Media Library

TMS (Neuromodulation) Clinical Trial Eligibility Overview. Trial Name: NCT04284267 — N/A
Bipolar Disorder Research Study Groups: Bipolar Group, Healthy Control
Bipolar Disorder Clinical Trial 2023: TMS Highlights & Side Effects. Trial Name: NCT04284267 — N/A
TMS (Neuromodulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04284267 — N/A
~1 spots leftby Jan 2025
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