N/A
N=18
Bipolar Transcranial Alternating Current Stimulation (tACS)
Bipolar Disorder
Bottom Line
View on ClinicalTrials.gov: NCT05480124 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Severity of Side Effects Reported at End of Stimulation Session as Reported by the Participant on the Stimulation Side Effects Questionnaire. — 5.66; 5.00 score on a scale — p=0.609
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- tACS brain stimulation treatment (Device); Sham stimulation treatment (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Severity of Side Effects Reported at End of Stimulation Session as Reported by the Participant on the Stimulation Side Effects Questionnaire. |
5.66; 5.00 | 0.609 |
| PRIMARY Participants Who Withdrew During or After the Stimulation Session |
0; 0 | — |
| PRIMARY Accuracy Signal Detection Theory Metric Sensitivity (d') Derived From the Behavioral Responses to Go and NoGo Trials on the Cognitive Control Task. |
2.08; 2.20 | 0.098 |
| PRIMARY Accuracy Signal Detection Theory Metric Response Bias Derived From the Behavioral Responses to Go and NoGo Trials on the Cognitive Control Task. |
-0.03; -0.05 | 0.204 |
| PRIMARY Reaction Time (in Milliseconds) of Go Trials on the Cognitive Control Task |
584.88; 582.01 | 0.383 |
| PRIMARY Theta-gamma Phase Amplitude Coupling (PAC) (Kullback-Leibler Modulation Index) During the Rest EEG Blocks Interleaved Between Stimulation Blocks. |
0.14; 0.20 | 0.201 |
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.
Data sourced from ClinicalTrials.gov (NCT05480124). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.