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Bipolar Transcranial Alternating Current Stimulation (tACS)

Primary Purpose

Bipolar Disorder

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

tACS brain stimulation treatment

Sham stimulation treatment

About this trial

This is an interventional treatment trial for Bipolar Disorder focused on measuring transcranial alternating current stimulation (tACS), electroencephalogram (EEG)

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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 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.
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.

Sites / Locations

University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Sham stimulation treatment

tACS brain stimulation treatment

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

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.

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.

Accuracy signal detection theory metric response bias derived from the behavioral responses to Go and NoGo trials on the cognitive control task.

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

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.

Theta-Gamma PAC represents the relationship between the phase of theta oscillations and the amplitude of gamma oscillations as measured by the EEG.

Secondary Outcome Measures

Full Information

NCT ID

NCT05480124

First Posted

July 26, 2022

Last Updated

June 28, 2023

Sponsor

University of Michigan

Collaborators

Milken Institute, Baszucki Brain Research Fund

1. Study Identification

Unique Protocol Identification Number

NCT05480124

Brief Title

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

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 20, 2023 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Michigan

Collaborators

Milken Institute, Baszucki Brain Research Fund

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Disorder

Keywords

transcranial alternating current stimulation (tACS), electroencephalogram (EEG)

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantOutcomes Assessor

Masking Description

Participants, study coordinator, and clinical assessor will be blind as to which session the participants receive active or sham treatment.

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sham stimulation treatment

Arm Type

Sham Comparator

Arm Description

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

Arm Title

tACS brain stimulation treatment

Arm Type

Experimental

Arm 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.

Intervention Type

Device

Intervention Name(s)

tACS brain stimulation treatment

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sham stimulation treatment

Intervention Description

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.

Primary Outcome Measure Information:

Title

Severity of side effects reported at end of stimulation session as reported by the participant on the Stimulation Side Effects Questionnaire.

Description

Time Frame

Change in outcome between Session 2 (approximately 60 minutes) and session 3 (approximately 60 minutes)

Title

Percentage of participants that withdrawal during or after the stimulation session

Description

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.

Time Frame

Change in outcome between Session 2 (approximately 60 minutes) and session 3 (approximately 60 minutes)

Title

Accuracy signal detection theory metric sensitivity (d') derived from the behavioral responses to Go and NoGo trials on the cognitive control task.

Description

D' (D prime) provides a measure of perceptual sensitivity to differing stimuli.

Time Frame

Change in outcome between Session 2 (approximately 60 minutes) and session 3 (approximately 60 minutes)

Title

Accuracy signal detection theory metric response bias derived from the behavioral responses to Go and NoGo trials on the cognitive control task.

Description

Beta (β) provides a measure of response bias, with negative β values indicating a stronger tendency to respond.

Time Frame

Change in outcome between Session 2 (approximately 60 minutes) and 3 (approximately 60 minutes)

Title

Reaction time (in milliseconds) of Go trials on the cognitive control task

Description

The separate sessions will be measured separately and compared to each other.

Time Frame

Change in outcome between Session 2 (approximately 60 minutes) and 3 (approximately 60 minutes)

Title

Theta-gamma PAC (Kullback-Leibler Modulation Index) during the rest EEG blocks interleaved between stimulation blocks.

Description

Theta-Gamma PAC represents the relationship between the phase of theta oscillations and the amplitude of gamma oscillations as measured by the EEG.

Time Frame

Change in outcome between Session 2 (approximately 60 minutes) and 3 (approximately 60 minutes)

Other Pre-specified Outcome Measures:

Title

Emotional Flanker Task - Accuracy

Description

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.

Time Frame

Approximately 30-60 minutes after the Go-NoGo task at all three time points (baseline, session 1, session 2)

Title

Emotional Flanker Task - Reaction time

Description

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.

Time Frame

Approximately 30-60 minutes after the Go-NoGo task at all three time points (baseline, session 1, session 2).

Title

Emotional Flanker Task - EEG

Description

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.

Time Frame

Approximately 30-60 minutes after the Go-NoGo task at all three time points (baseline, session 1, session 2).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Laura Locarno

Phone

734-232-4585

tacs_study@med.umich.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stephan F Taylor, MD

Organizational Affiliation

University of Michigan

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Michigan

City

Ann Arbor

State/Province

Michigan

ZIP/Postal Code

48109

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Laura Stchur, MSW

Phone

734-936-1323

lmarine@med.umich.edu

First Name & Middle Initial & Last Name & Degree

Ivy Tso, PhD

12. IPD Sharing Statement

Plan to Share IPD

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Bipolar Transcranial Alternating Current Stimulation (tACS)

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