Bipolar Transcranial Alternating Current Stimulation (tACS)

University of Michigan

Status: Completed

Conditions: Bipolar Disorder

Treatments: Device: Sham stimulation treatment; Device: tACS brain stimulation treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT05480124

HUM00208557

Details and patient eligibility

About

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.

Enrollment: 18 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed diagnosis of BD based on Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria being met from previous enrollment in the Prechter Bipolar Longitudinal Study
• This study will select BD patients that scored above published norms (upper 50th percentile) on the NEO-PI impulsivity facet to ensure that the recruited patients exhibit the network dysfunction targeted by the tACS paradigm and therefore have the potential to benefit from this neuromodulation technique.
• Patients must be on a stable dose of medication for two weeks prior to Sessions 2 and 3.

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 Substance Use Disorder module of SCID)
• Evidence of suicidal intentions or behaviors in the past month, as judged by affirmative responses to question number 4 or number 5 on the Columbia Suicide Severity Rating Scale (CSSRS) or report of suicidal behaviors in the last 6 months
• Pregnant or trying to become pregnant, or currently lactating.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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18 participants in 2 patient groups

Sham stimulation treatment

Sham Comparator group

Description:

Sham stimulation during a computerized task and electroencephalogram (EEG) recording.

Treatment:

Device: Sham stimulation treatment

tACS brain stimulation treatment

Experimental group

Description:

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.

Treatment:

Device: tACS brain stimulation treatment