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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

Study 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.Check my eligibility
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.See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Emotion Conflict Resolution Task
Multisource Interference Task with International Affective Pictures Set (MSIT-IAPS)
Secondary outcome measures
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

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
2,933 Previous Clinical Trials
13,198,441 Total Patients Enrolled
68 Trials studying Bipolar Disorder
15,464 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

Frequently Asked Questions

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

Are there any unfilled vacancies available to join this clinical trial?

"Affirmative. Per the information recorded on clinicaltrials.gov, this research initiative is currently looking for participants. Initially posted on March 1st 2021, with subsequent updates made on May 3rd of 2022, 60 patients are being sought out from a single centre."

Answered by AI

Is the age criterion for this experiment limited to individuals over 25 years old?

"As indicated by the inclusion criteria, this medical trial is limited to participants aged 22 and 55. For individuals below 18 years old or over 65 there are 35 trials available and 151 respective options respectively."

Answered by AI

How many individuals are being included in this experiment?

"Affirmative. The clinicaltrials.gov database shows that this trial is currently recruiting participants–it was first uploaded on March 1st 2021 and its latest update occurred on May 3rd 2022. This study requires 60 individuals at a single medical facility to be recruited for participation."

Answered by AI

Are there any opportunities for me to join this experiment?

"This medical trial is enrolling 60 individuals aged between 22 and 55 who have been diagnosed with manic disorder. Besides this, potential participants should be male or female adults over the age of 18 without any history of psychiatric conditions as determined by the Mini-International Neuropsychiatric Interview (MINI). Furthermore, applicants must present nonclinical levels of emotion dysregulation based on their score in the Difficulties in Emotion Regulation Scale (DERS), which will be defined as a score below 80."

Answered by AI

What objectives are the researchers hoping to achieve with this clinical endeavor?

"The main objective of this trial, which will be monitored across a Change from Baseline to Post-TMS Stimulation (30 min-1 hour) period is the evaluation of Multisource Interference Task with International Affective Pictures Set (MSIT-IAPS). Supplementary metrics include Skin Conductance Response - recording electrodermal skin response via electrodes sensors on fingertips., ECR Task-induced blood oxygen level dependent (BOLD) signal tracking task performance and distress ratings during Cognitive Reappraisal tasks., as well as MSIT-IAPS Task-induced blood oxygen level dependent (BOLD) signal noting differences between CI versus"

Answered by AI
~10 spots leftby Jan 2025