Bipolar Transcranial Alternating Current Stimulation (tACS)

Bipolar Disorder Clinical Trial

Official title:

Enhancing Neural Synchrony and Affective Cognitive Control in Bipolar Disorder Using Personalized Transcranial Alternating Current Stimulation (tACS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05480124
• Other study ID #: HUM00208557
• Status: Completed
• Phase: N/A
• Start date: April 20, 2023
• Est. completion date: January 6, 2024

Study information

• Verified date: January 2024
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: January 6, 2024
• Est. primary completion date: December 6, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bipolar Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	Baszucki Brain Research Fund, Milken Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Emotional Flanker Task - Accuracy	After completing the Emotion Go-NoGo task, participants will complete another cognitive control task (i.e., Emotional Flanker Task) with gray-scaled unpleasant, pleasant, and neural images from the International Affective Picture System. Participants are tasked with indicating which valance is presented in certain images while ignoring other images. Accuracy is defined as the percentage of trials that the participant correctly reports the valance of the target image. The total number of correct trials will be divided by the total number of trials to obtain an accuracy score. Average accuracy scores per condition and total will be calculated.	Approximately 30-60 minutes after the Go-NoGo task at all three time points (baseline, session 1, session 2)
Other	Emotional Flanker Task - Reaction time	Reaction time will also be collected during the Emotional Flanker Task. Reaction time is defined as the length of time it takes the participant to respond after the onset of the stimuli. Average reaction times per condition and total will be calculated.	Approximately 30-60 minutes after the Go-NoGo task at all three time points (baseline, session 1, session 2).
Other	Emotional Flanker Task - EEG	EEG will also be collected during the Emotional Flanker Task. Phase-amplitude coupling will be calculated and defined as the coupling between the amplitude of high frequency oscillations (e.g., gamma) and low frequency phase (e.g., theta). Average coupling scores per condition and total will be calculated.	Approximately 30-60 minutes after the Go-NoGo task at all three time points (baseline, session 1, session 2).
Primary	Severity of side effects reported at end of stimulation session as reported by the participant on the Stimulation Side Effects Questionnaire.	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.	Change in outcome between Session 2 (approximately 60 minutes) and session 3 (approximately 60 minutes)
Primary	Percentage of participants that withdrawal during or after the stimulation session	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.	Change in outcome between Session 2 (approximately 60 minutes) and session 3 (approximately 60 minutes)
Primary	Accuracy signal detection theory metric sensitivity (d') derived from the behavioral responses to Go and NoGo trials on the cognitive control task.	D' (D prime) provides a measure of perceptual sensitivity to differing stimuli.	Change in outcome between Session 2 (approximately 60 minutes) and session 3 (approximately 60 minutes)
Primary	Accuracy signal detection theory metric response bias derived from the behavioral responses to Go and NoGo trials on the cognitive control task.	Beta (ß) provides a measure of response bias, with negative ß values indicating a stronger tendency to respond.	Change in outcome between Session 2 (approximately 60 minutes) and 3 (approximately 60 minutes)
Primary	Reaction time (in milliseconds) of Go trials on the cognitive control task	The separate sessions will be measured separately and compared to each other.	Change in outcome between Session 2 (approximately 60 minutes) and 3 (approximately 60 minutes)
Primary	Theta-gamma PAC (Kullback-Leibler Modulation Index) during the rest EEG blocks interleaved between stimulation blocks.	Theta-Gamma PAC represents the relationship between the phase of theta oscillations and the amplitude of gamma oscillations as measured by the EEG.	Change in outcome between Session 2 (approximately 60 minutes) and 3 (approximately 60 minutes)