Clinical trial NCT05480124: Bipolar Transcranial Alternating Current Stimulation (tACS)
Official title: Enhancing Neural Synchrony and Affective Cognitive Control in Bipolar Disorder Using Personalized Transcranial Alternating Current Stimulation (tACS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bipolar Disorder
Keywords: transcranial alternating current stimulation (tACS)
electroencephalogram (EEG)
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Milken Institute
name: Baszucki Brain Research Fund
First posted: 2022-07-29
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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 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.

Primary outcomes:
measure: Severity of Side Effects Reported at End of Stimulation Session as Reported by the Participant on the Stimulation Side Effects Questionnaire.
timeFrame: Up to 3 weeks
measure: Participants Who Withdrew During or After the Stimulation Session
timeFrame: Up to 3 weeks
measure: Accuracy Signal Detection Theory Metric Sensitivity (d') Derived From the Behavioral Responses to Go and NoGo Trials on the Cognitive Control Task.
timeFrame: Up to 3 weeks
measure: Accuracy Signal Detection Theory Metric Response Bias Derived From the Behavioral Responses to Go and NoGo Trials on the Cognitive Control Task.
timeFrame: Up to 3 weeks
measure: Reaction Time (in Milliseconds) of Go Trials on the Cognitive Control Task
timeFrame: Up to 3 weeks
measure: Theta-gamma Phase Amplitude Coupling (PAC) (Kullback-Leibler Modulation Index) During the Rest EEG Blocks Interleaved Between Stimulation Blocks.
timeFrame: Up to 3 weeks
Secondary outcomes:
Other outcomes:
measure: Emotional Flanker Task - Accuracy
timeFrame: Approximately 30-60 minutes after the Go-NoGo task at all three time points (baseline, session 1, session 2)
measure: Emotional Flanker Task - Reaction Time
timeFrame: Approximately 30-60 minutes after the Go-NoGo task at all three time points (baseline, session 1, session 2).
measure: Emotional Flanker Task - EEG
timeFrame: Approximately 30-60 minutes after the Go-NoGo task at all three time points (baseline, session 1, session 2).
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Stephan F Taylor, MD
role: PRINCIPAL_INVESTIGATOR
References: