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| Name | Class |
|---|---|
| Milken Institute | OTHER |
| Baszucki Brain Research Fund | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sham stimulation treatment | Sham Comparator | Sham stimulation during a computerized task and electroencephalogram (EEG) recording. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephan F Taylor, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42381254 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Sham First, Then tACS | Participants in this arm received the sham stimulation treatment during session 2 and then received the tACS brain stimulation treatment in session 3. |
| FG001 | tACS, Then Sham | Participants in this arm received the tACS brain stimulation treatment in session 2 and then received the sham stimulation treatment during session 3. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Session 1 (Baseline) |
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| Session 2 |
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| Washout |
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| Session 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Sham First, Then tACS | Participants in this arm received the sham stimulation treatment during session 2 and then received the tACS brain stimulation treatment in session 3. |
| BG001 | tACS, Then Sham |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | score on a scale | Up to 3 weeks |
|
Up to 7 weeks
Participants were called 30 days after the final visit and asked if they had any side effects from the tACS.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Sham Stimulation Treatment | Sham stimulation during a computerized task and electroencephalogram (EEG) recording. 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephan Taylor | University of Michigan | (734) 936-4955 | sftaylor@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 12, 2023 | Oct 22, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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Participants, study coordinator, and clinical assessor will be blind as to which session the participants receive active or sham 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. |
|
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 |
| Approximately 30-60 minutes after the Go-NoGo task at all three time points (baseline, session 1, session 2) |
| 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). |
| 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). |
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Participants in this arm received the tACS brain stimulation treatment in session 2 and then received the sham stimulation treatment during session 3.
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| OG001 | 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. 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. |
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| Primary | 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. | Posted | Count of Participants | Participants | Up to 3 weeks |
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| Primary | 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. | Posted | Mean | Standard Deviation | z-score | Up to 3 weeks |
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| Primary | 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). | Posted | Mean | Standard Deviation | z-score | Up to 3 weeks |
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| Primary | 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. | Posted | Mean | Standard Deviation | milliseconds | Up to 3 weeks |
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| Primary | 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). | Data was not collected from 1 participant in the sham arm, as their EEG data was unreadable following administration of the sham. | Posted | Mean | Standard Deviation | arbitrary units | Up to 3 weeks |
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| Other Pre-specified | 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. | Not Posted | Approximately 30-60 minutes after the Go-NoGo task at all three time points (baseline, session 1, session 2) | Participants |
| Other Pre-specified | 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. | Not Posted | Approximately 30-60 minutes after the Go-NoGo task at all three time points (baseline, session 1, session 2). | Participants |
| Other Pre-specified | 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. | Not Posted | Approximately 30-60 minutes after the Go-NoGo task at all three time points (baseline, session 1, session 2). | Participants |
| 0 |
| 18 |
| 0 |
| 18 |
| 0 |
| 18 |
| EG001 | 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. 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. | 0 | 18 | 0 | 18 | 0 | 18 |
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