Bipolar Transcranial Alternating Current Stimulation (tACS)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Sham Comparator: Sham stimulation treatment Sham stimulation during a computerized task and electroencephalogram (EEG) recording. |
Device: Sham stimulation treatment
Participants will wear an EEG cap on the head attached with EEG-recording and tACS electrodes. Sham tACS will be delivered by passing a transient (approximately 12 seconds ) small electrical current via the tACS electrodes during a computerized behavioral task. The effect of sham stimulation on EEG will be measured via EEG-recording electrodes during short rests (between stimulation blocks). The sham stimulation session will last for approximately 60 minutes. After treatment, participants will be asked about the experience and if there are any side effects.
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| Experimental: tACS brain stimulation treatment 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. |
Device: tACS brain stimulation treatment
Participants will wear an EEG cap on the head attached with EEG-recording and tACS electrodes. tACS will be delivered by passing a small electrical current via the tACS electrodes to the scalp to stimulate brain activity during a computerized behavioral task. The effect of active stimulation on EEG will be measured via EEG-recording electrodes during short rests (between stimulation blocks). The stimulation session will last for approximately 60 minutes. After treatment, participants will be asked about the experience and if there are any side effects.
|
Outcome Measures
Primary Outcome Measures
- Severity of side effects reported at end of stimulation session as reported by the participant on the Stimulation Side Effects Questionnaire. [Change in outcome between Session 2 (approximately 60 minutes) and session 3 (approximately 60 minutes)]
The score is calculated by summing the severity score of items (0-4) that are rated by the participant as related to stimulation (ratings of 3=probable or 4=definite) on the Stimulation Side Effects Questionnaire. There are a total of 14 symptoms as well as an other category with scores ranging from 0-56 and the possibility of more points if other symptoms are recorded.
- Percentage of participants that withdrawal during or after the stimulation session [Change in outcome between Session 2 (approximately 60 minutes) and session 3 (approximately 60 minutes)]
The study team will compare the percentage of participants requesting to discontinue the session and the severity of side effects reported following the tACS vs. sham procedure.
- Accuracy signal detection theory metric sensitivity (d') derived from the behavioral responses to Go and NoGo trials on the cognitive control task. [Change in outcome between Session 2 (approximately 60 minutes) and session 3 (approximately 60 minutes)]
D' (D prime) provides a measure of perceptual sensitivity to differing stimuli.
- Accuracy signal detection theory metric response bias derived from the behavioral responses to Go and NoGo trials on the cognitive control task. [Change in outcome between Session 2 (approximately 60 minutes) and 3 (approximately 60 minutes)]
Beta (β) provides a measure of response bias, with negative β values indicating a stronger tendency to respond.
- Reaction time (in milliseconds) of Go trials on the cognitive control task [Change in outcome between Session 2 (approximately 60 minutes) and 3 (approximately 60 minutes)]
The separate sessions will be measured separately and compared to each other.
- Theta-gamma PAC (Kullback-Leibler Modulation Index) during the rest EEG blocks interleaved between stimulation blocks. [Change in outcome between Session 2 (approximately 60 minutes) and 3 (approximately 60 minutes)]
Theta-Gamma PAC represents the relationship between the phase of theta oscillations and the amplitude of gamma oscillations as measured by the EEG.
Eligibility Criteria
Criteria
Inclusion Criteria:
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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
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This study will select BD patients that scored 1.5 standard deviations (SDs) above published norms on the total score of the Barratt Impulsiveness Scale 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.
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Patients must be on a stable dose of medication for two weeks prior to Sessions 2 and
Exclusion Criteria:
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Significant neurological abnormalities, such as seizure disorder, mass lesions, etc.
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Known Mendelian disorder
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Active problematic substance use in the past 30 days (as determined by the Substance Use Disorder module of SCID)
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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
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Pregnant or trying to become pregnant, or currently lactating.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
- Milken Institute
- Baszucki Brain Research Fund
Investigators
- Principal Investigator: Ivy Tso, PhD, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00208557