Bipolar Transcranial Alternating Current Stimulation (tACS)

NCT05480124 | Completed Results FDA Device

• 1 other identifier: HUM00208557
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Severity of Side Effects Reported at End of Stimulation Session as Reported by the Participant on the Stimulation Side Effects Questionnaire.

  The score was calculated by summing the severity score of items that were rated by the participant as related to stimulation on the Stimulation Side Effects Questionnaire. There was a total of 14 symptoms listed on the questionnaire. Participants rated each item rated on a scale of 0-4, with 0 meaning no relation and 4 meaning definitely related. The total possible range of the questionnaire was 0-56.

  Up to 3 weeks

• Participants Who Withdrew During or After the Stimulation Session

  Results reflect the number of participants who withdrew from the trial during or after a stimulation session with either the tACS or the sham stimulation treatment.

  Up to 3 weeks

• Accuracy Signal Detection Theory Metric Sensitivity (d') Derived From the Behavioral Responses to Go and NoGo Trials on the Cognitive Control Task.

  The Go/NoGo task was a cognitive task, where participants were shown "go" stimuli (i.e., go trials) and "no-go" stimuli and responded by pressing a button when seeing "go" stimuli and not responding when seeing the "no-go" stimuli. Accuracy was measured by calculating D' (D prime), which provided a measure of perceptual sensitivity to the differing stimuli. Larger values of D' indicated greater discernability (i.e., accuracy) between the Go and NoGo trials. D-prime, also called the sensitivity index represents how well someone can detect a signal amidst background noise. At its core, D-prime is the standardized difference between the means of the Signal Present and Signal Absent distributions, which can be calculated by taking the difference between the Z-score of the False Alarm Rate and the Z-scores of the Hit Rate. A D-prime of 0 means no sensitivity. Negative D-prime values are rare and may indicate errors or reversed interpretations of hits and false alarms.

  Up to 3 weeks

• Accuracy Signal Detection Theory Metric Response Bias Derived From the Behavioral Responses to Go and NoGo Trials on the Cognitive Control Task.

  The Go/NoGo task was a cognitive task, where participants were shown "go" stimuli (i.e., go trials) and "no-go" stimuli and responded by pressing a button when seeing "go" stimuli and not responding when seeing the "no-go" stimuli. Response bias was measured using beta, such that more negative beta values indicated a stronger tendency to respond to all stimuli, regardless of "go" or "no-go" status. Response bias is indexed by taking the average between the Z-score of the False Alarm Rate and the Z-scores of the Hit Rate. A higher response bias indicates that the participant is more likely to respond "signal absent" (favors avoiding false alarms but increases misses). A response bias of 0 means the individual equally weighs the costs of misses and false alarms. A more negative response bias indicated that the participant is more likely to respond "signal present" (favors hits but increases false alarms).

  Up to 3 weeks

• Reaction Time (in Milliseconds) of Go Trials on the Cognitive Control Task

  Participants' reaction time to responding to the "Go" signal during the Go/NoGo task was measured.

  Up to 3 weeks

• Theta-gamma Phase Amplitude Coupling (PAC) (Kullback-Leibler Modulation Index) During the Rest EEG Blocks Interleaved Between Stimulation Blocks.

  Theta-gamma phase-amplitude coupling (PAC) is a neural phenomenon observed in the brain, where the phase of slower theta oscillations modulates the amplitude of faster gamma oscillations. This type of coupling is thought to play a critical role in various cognitive control. For the trial, higher PAC values indicated higher levels of coupling or connection between the two frequencies (i.e., increased cognitive control).

  Up to 3 weeks

Other Outcomes (3)

• Emotional Flanker Task - Accuracy

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

• Emotional Flanker Task - Reaction Time

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

• Emotional Flanker Task - EEG

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

Study Arms (2)

Sham stimulation treatment

SHAM COMPARATOR

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

Device: Sham stimulation treatment

tACS brain stimulation treatment

EXPERIMENTAL

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

Interventions

tACS brain stimulation treatment DEVICE

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.

tACS brain stimulation treatment

Sham stimulation treatment DEVICE

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.

Sham stimulation treatment

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead
• Milken Institute: collaborator
• Baszucki Brain Research Fund: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Stephan Taylor
• Organization: University of Michigan

sftaylor@med.umich.edu

(734) 936-4955

Study Officials

• Stephan F Taylor, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants, study coordinator, and clinical assessor will be blind as to which session the participants receive active or sham treatment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: July 26, 2022
• First Posted: July 29, 2022
• Study Start: April 20, 2023
• Primary Completion: December 6, 2023
• Study Completion: January 6, 2024
• Last Updated: January 14, 2025
• Results First Posted: January 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)