Bipolar Transcranial Alternating Current Stimulation (tACS)

Last updated: December 19, 2024
Sponsor: University of Michigan
Overall Status: Completed

Phase

N/A

Condition

Bipolar Disorder

Mood Disorders

Treatment

tACS brain stimulation treatment

Sham stimulation treatment

Clinical Study ID

NCT05480124
HUM00208557
  • Ages 18-55
  • All Genders

Study Summary

The purpose of this clinical trial is to measure the safety and effectiveness of a non-invasive brain stimulation device called Transcranial Alternating Current Stimulation (tACS) in participants with bipolar disorder (BD).

Participants will be asked to come in for 3 sessions. If participants qualify at the screening visit (session 1) then enrolled participants will complete sessions 2 and 3 as well as have a 30-day follow-up phone call.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Confirmed diagnosis of BD based on Diagnostic and Statistical Manual of MentalDisorders Fourth Edition (DSM-IV) criteria being met from previous enrollment in thePrechter Bipolar Longitudinal Study

  • This study will select BD patients that scored above published norms (upper 50thpercentile) on the NEO-PI impulsivity facet to ensure that the recruited patientsexhibit the network dysfunction targeted by the tACS paradigm and therefore have thepotential to benefit from this neuromodulation technique.

  • Patients must be on a stable dose of medication for two weeks prior to Sessions 2and 3.

Exclusion

Exclusion Criteria:

  • Significant neurological abnormalities, such as seizure disorder, mass lesions, etc.

  • Known Mendelian disorder

  • Active problematic substance use in the past 30 days (as determined by the SubstanceUse Disorder module of SCID)

  • Evidence of suicidal intentions or behaviors in the past month, as judged byaffirmative responses to question number 4 or number 5 on the Columbia SuicideSeverity Rating Scale (CSSRS) or report of suicidal behaviors in the last 6 months

  • Pregnant or trying to become pregnant, or currently lactating.

Study Design

Total Participants: 18
Treatment Group(s): 2
Primary Treatment: tACS brain stimulation treatment
Phase:
Study Start date:
April 20, 2023
Estimated Completion Date:
January 06, 2024

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

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