Bipolar DisorderNCT05480124
Bipolar Transcranial Alternating Current Stimulation (tACS)
A study testing tACS brain stimulation treatment in people with Bipolar Disorder, run by University of Michigan at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Bipolar Disorder
- What is being tested?
- tACS brain stimulation treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2023to 6 Jan 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancing Neural Synchrony and Affective Cognitive Control in Bipolar Disorder Using Personalized Transcranial Alternating Current Stimulation (tACS)
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
- Being tested
- tACS brain stimulation treatment, Sham stimulation treatment
- Keywords
- transcranial alternating current stimulation (tACS), electroencephalogram (EEG)
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tACS brain stimulation treatmentDevice
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 treatmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Sham stimulation treatment | Sham comparator | Sham stimulation during a computerized task and electroencephalogram (EEG) recording. Receives: 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. Receives: Device: tACS brain stimulation treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
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).
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start20 Apr 2023
- Primary completion6 Dec 2023
- Study completion6 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Milken Institute, Baszucki Brain Research Fund
- Responsible party
- Principal investigator, Stephan F. Taylor, University of Michigan
- Investigators
- Stephan F Taylor, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480124
- Sponsor's protocol ID
- HUM00208557
- Status last verified
- Dec 2024
- First submitted
- 26 Jul 2022
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kraft JD, Locarno L, Suzuki T, Riddle J, Chang SE, McInnis MG, Frohlich F, Taylor SF, Tso IF. Enhancing Affective Cognitive Control in Bipolar Disorder Using Transcranial Alternating Current Stimulation: A Double-Blind, Randomized, Sham-Controlled Clinical Trial and Proof of Concept Study. Bipolar Disord. 2026 Aug;28(5):e70142. doi: 10.1111/bdi.70142.
PubMed 42381254
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Neural Synchrony and Affective Cognitive Control in Bipolar Disorder Using Personalized Transcranial Alternating Current Stimulation (tACS)
- ClinicalTrials.gov ID
- NCT05480124
- Acronym / sponsor ID
- HUM00208557
- Conditions
- Bipolar Disorder
- Keywords
- transcranial alternating current stimulation (tACS), electroencephalogram (EEG)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Milken Institute, Baszucki Brain Research Fund
- Study start
- 20 Apr 2023 (actual)
- Primary completion
- 6 Dec 2023 (actual)
- Study completion
- 6 Jan 2024 (actual)
- First posted
- 29 Jul 2022 (actual)
- Results
- Posted 14 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham stimulation treatment | Sham comparator | Device: Sham stimulation treatmentSham stimulation during a computerized task and electroencephalogram (EEG) recording. |
| tACS brain stimulation treatment | Experimental | Device: tACS brain stimulation treatmenttACS 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tACS brain stimulation treatmentParticipants 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. | Device | tACS brain stimulation treatment |
| Sham stimulation treatmentParticipants 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. | Device | Sham stimulation treatment |
Primary outcome
Severity of Side Effects Reported at End of Stimulation Session as Reported by the Participant on the Stimulation Side Effects Questionnaire.
Time frame: Up to 3 weeks
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.
Participants Who Withdrew During or After the Stimulation Session
Time frame: Up to 3 weeks
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.
Accuracy Signal Detection Theory Metric Sensitivity (d') Derived From the Behavioral Responses to Go and NoGo Trials on the Cognitive Control Task.
Time frame: Up to 3 weeks
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.
Accuracy Signal Detection Theory Metric Response Bias Derived From the Behavioral Responses to Go and NoGo Trials on the Cognitive Control Task.
Time frame: Up to 3 weeks
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).
Reaction Time (in Milliseconds) of Go Trials on the Cognitive Control Task
Time frame: Up to 3 weeks
Participants' reaction time to responding to the "Go" signal during the Go/NoGo task was measured.
Theta-gamma Phase Amplitude Coupling (PAC) (Kullback-Leibler Modulation Index) During the Rest EEG Blocks Interleaved Between Stimulation Blocks.
Time frame: Up to 3 weeks
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).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42381254Kraft JD, Locarno L, Suzuki T, Riddle J, Chang SE, McInnis MG, Frohlich F, Taylor SF, Tso IF. Enhancing Affective Cognitive Control in Bipolar Disorder Using Transcranial Alternating Current Stimulation: A Double-Blind, Randomized, Sham-Controlled Clinical Trial and Proof of Concept Study. Bipolar Disord. 2026 Aug;28(5):e70142. doi: 10.1111/bdi.70142.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephan F Taylor, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tACS brain stimulation treatment in people with Bipolar Disorder, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of Side Effects Reported at End of Stimulation Session as Reported by the Participant on the Stimulation Side Effects Questionnaire. (time frame: Up to 3 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05480124, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2025.