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Brain Stimulation Device

tACS Brain Stimulation for Bipolar Disorder

N/A
Waitlist Available
Led By Stephan F Taylor, MD
Research Sponsored by University of Michigan
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 30-60 minutes after the go-nogo task at all three time points (baseline, session 1, session 2)
Awards & highlights

Study Summary

This trial is measuring the safety and effectiveness of a brain stimulator in people with bipolar disorder.

Who is the study for?
This trial is for individuals with bipolar disorder who are part of the Prechter Bipolar Longitudinal Study, have high impulsivity scores, and have been on stable medication doses for two weeks. It excludes those with genetic disorders, pregnancy or lactation, recent substance abuse issues, significant neurological conditions, or recent suicidal behavior.Check my eligibility
What is being tested?
The trial tests a non-invasive brain stimulation device called tACS to see if it's safe and effective in treating bipolar disorder. Participants will undergo three sessions of either real tACS treatment or a sham (fake) treatment to compare outcomes.See study design
What are the potential side effects?
While not explicitly listed here, potential side effects may include discomfort at the stimulation site, headache, dizziness or other mild symptoms related to non-invasive brain stimulation treatments.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 30-60 minutes after the go-nogo task at all three time points (baseline, session 1, session 2).
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 30-60 minutes after the go-nogo task at all three time points (baseline, session 1, session 2). for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Accuracy signal detection theory metric response bias derived from the behavioral responses to Go and NoGo trials on the cognitive control task.
Accuracy signal detection theory metric sensitivity (d') derived from the behavioral responses to Go and NoGo trials on the cognitive control task.
Percentage of participants that withdrawal during or after the stimulation session
+3 more
Other outcome measures
Emotional Flanker Task - Accuracy
Emotional Flanker Task - EEG
Emotional Flanker Task - Reaction time

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: tACS brain stimulation treatmentExperimental Treatment1 Intervention
tACS brain stimulation during a computerized task and EEG recording. Participants will receive tACS using individualized peak Phase-amplitude coupling (PAC) frequency pairs determined in Session 1.
Group II: Sham stimulation treatmentPlacebo Group1 Intervention
Sham stimulation during a computerized task and electroencephalogram (EEG) recording.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
tACS brain stimulation treatment
2023
N/A
~20

Find a Location

Who is running the clinical trial?

University of MichiganLead Sponsor
1,794 Previous Clinical Trials
6,373,898 Total Patients Enrolled
19 Trials studying Bipolar Disorder
3,194 Patients Enrolled for Bipolar Disorder
Baszucki Brain Research FundOTHER
6 Previous Clinical Trials
297 Total Patients Enrolled
5 Trials studying Bipolar Disorder
287 Patients Enrolled for Bipolar Disorder
Milken InstituteOTHER
7 Previous Clinical Trials
269 Total Patients Enrolled
6 Trials studying Bipolar Disorder
263 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.

Is this clinical trial only for patients who are 35 years old or younger?

"This particular clinical trial only enrolls patients that are between 18-55 years old. There are 23 other trials for pediatric patients and 117 trials for geriatric patients."

Answered by AI

Am I eligible to participate in this research study?

"Researchers conducting this study are looking for 30 participants, all of whom must meet the following eligibility criteria: A diagnosis of BD that has been confirmed through DSM-IV criteria and enrollment in the Prechter Bipolar Longitudinal Study, a total score on the Barratt Impulsiveness Scale that is 1.5 SDs above published norms, being on a stable dose of medication for 2 weeks prior to Sessions 2 and 3.."

Answered by AI

Are recruitment efforts for this trial still ongoing?

"Negative. The relevant information from clinicaltrials.gov suggests that this study is not looking for new candidates at the moment. Although, it's worth noting that there are other 163 trials currently enrolling patients."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What site did they apply to?
University of Michigan
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+

Why did patients apply to this trial?

I have tried many antidepressants that didn't work or work for long. I want to help the medical field improve its understanding of bipolar and help to find more effective treatments for all types of patients.
PatientReceived 2+ prior treatments
I have bipolar disorder and feel that it is not currently well-controlled by my medications, nor the other medications I have tried in the past. During my depressive episodes I experience suicidal ideation, and during my manic episodes I make poor choices that impact my relationships and career. I need additional treatment options.
PatientReceived 1 prior treatment
~9 spots leftby Apr 2025