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)

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 30-60 minutes after the go-nogo task at all three time points (baseline, session 1, session 2).

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 study objectives

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

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