Bipolar DisorderTACTIC-BDNCT07845409
Targeted Alternating Current and Cognitive Training Intervention for Cognitive Control in Bipolar Disorders
A study testing Soterix 1x1 tES mini-CT in people with Bipolar Disorder and Bipolar and Related Disorders, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This study is testing whether a type of gentle brain stimulation, combined with computer-based brain training exercises, can help improve thinking skills in Veterans with bipolar disorder. Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bipolar Disorder, Bipolar and Related Disorders, Veterans
- What is being tested?
- Soterix 1x1 tES mini-CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2027to 31 Mar 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Veteran
- Capacity to provide voluntary informed consent
- English language fluency
- Stable dose of prescription and non-prescription medications that may impact cognition for at least 3 weeks prior to consent
- Bipolar Disorder (BD) cohort only: A primary diagnosis of Bipolar I Disorder, Bipolar II Disorder, or Other Specified Bipolar Disorder (i.e., those with major depressive episodes and hypomania that meet all episode criteria but for duration)
Who cannot join
- Presence of a medical, psychiatric, physical or non-physical disease, disorder, condition, injury, disability or pre-existent history such that study participation, in the opinion of the study investigators: a) May pose a significant risk to the participant, b) raises the possibility that the participant is unlikely to successfully complete all the requirements of the study according to the study protocol, or c) might adversely impact the integrity of the data or the validity of the study results. Specific conditions may include (but are not limited to) a history of brain tumor near the stimulation site, brain surgery, severe traumatic brain injury (TBI) (LOC >24 hours, GCS 3-8), stroke with current sequalae, epilepsy, Multiple Sclerosis, Huntington's Disease, ALS, ataxia, aphasia, Alzheimer's Disease, dementia, cardiac pacemaker or defibrillator, blindness, or deafness.
- Bipolar Disorder (BD) cohort only: a) Current/acute episode criteria met for any Bipolar Disorder (BD) episode (i.e., hypomania, mania, depression) for the month prior to consent as assessed by SCID-5-RV's Module A, b) Current/acute substance use disorder with severe specifier and/or evidence of withdrawal or increased tolerance, as assessed by SCID-5-RV's Module E, c) Contraindications for transcranial alternating current stimulation (tACS), e.g., metallic cranial or facial implant, dermatologic conditions on the forehead, etc. d) No or limited internet connection in their home
- Control cohort only: a) Current or lifetime bipolar disorders or symptoms of psychosis assessed by SCID-5-RV, and/or b) Clinically significant mental health disorders within 2 years of consent (e.g., major depressive disorder, generalized anxiety disorder, post-traumatic stress disorder, substance use disorder as specified in 2b) as assessed by SCID-5-RV
- Court-appointed legal guardianship
- Cognitive training or neuromodulation treatments for clinical or research purposes within 30 days of consent or during study period (consent to final follow-up)
- Electroconvulsive Therapy (ECT) within 12 months of consent or during study period
Show all 9Show fewer
- Baseline MoCA score <18 or MoCA-Blind score <19
- Baseline acute severe suicidal ideation as determined by a score > 3 on the Depressive Symptom Index-Suicidality Subscale (DSI-SS)
- Positive pregnancy screen in participants of childbearing potential
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309
Alicia L Fenske, BA, (612) 467-4744 ext. 314744, alicia.fenske@va.gov
Isaac T Thao, (612) 467-2000, isaac.thao@va.gov
About this study
Official title: Targeted Alternating Current and Cognitive Training Intervention for Cognitive Control in Bipolar Disorders (TACTIC-BD)
This study is testing whether a type of gentle brain stimulation, combined with computer-based brain training exercises, can help improve thinking skills in Veterans with bipolar disorder. Veterans with bipolar disorder may have difficulty with skills like stopping to think before acting or adjusting their behavior when things change - problems that can affect daily life and have been linked to a higher risk of serious outcomes.
In this study, Veterans with bipolar disorder will complete brain training exercises at home on a computer, paired with a mild electrical brain stimulation called transcranial alternating current stimulation (tACS), delivered through a small headband worn on the forehead. Some participants will receive real stimulation and some will receive an inactive ("sham") version, and neither participants nor most study staff will know which one a person is receiving. All participants will also complete brain wave recordings (EEG), interviews, questionnaires, and various thinking tasks before and after the study to measure any changes. A separate group of Veterans without bipolar disorder will complete the same tests, without any brain stimulation or training, to help researchers understand how much change would happen naturally just from taking the same tests more than once.
The goal of this research is to learn whether this combined treatment approach is safe, tolerable, and helpful for improving thinking skills in Veterans with bipolar disorder, and whether Veterans find it an acceptable treatment worth continuing.
Read the detailed description
Veterans with bipolar disorder (BD) are at elevated risk for suicide, recurrent homelessness, and disability, and existing pharmacological and psychosocial treatments show limited efficacy for the cognitive dysfunction that underlies these outcomes. Cognitive control (CC) - encompassing response inhibition, error monitoring, and adaptive responding to changing contingencies - is a core, trait-like neurocognitive deficit in BD that persists across mood states (mania, depression, euthymia) and is mechanistically linked to symptom severity and suicidality. No prior studies have examined neuromodulation targeting CC processes in Veterans with BD.
This study is a randomized, double-blind, sham-controlled trial testing whether transcranial alternating current stimulation (tACS) targeting frontal theta oscillations, delivered concurrently with CC-relevant cognitive training, improves neural and behavioral indices of CC beyond cognitive training alone. Ninety-two Veterans with a DSM-5 diagnosis of Bipolar I, Bipolar II, or Other Specified Bipolar Disorder will complete a baseline assessment battery, including self-report measures, EEG (resting-state and task-based), and behavioral paradigms indexing CC in both affective and non-affective contexts (e.g., Go/NoGo, Dot Pattern Expectancy, Monetary Incentive Delay tasks). Participants will then be randomized 1:1 to 10 sessions of active (5Hz, 1mA) or sham frontal theta-frequency tACS (electrodes at F3/F4), each paired with concurrent computerized cognitive training (BrainHQ) targeting working memory, inhibitory control, set-shifting, and attention. All intervention sessions will be self-administered in participants' homes under real-time remote supervision via videoconference. Follow-up assessments repeating the baseline CC battery will occur at approximately 1-week and 2-months post-intervention.
An additional 46 Veterans without major psychopathology will complete an identical assessment schedule (baseline and two follow-up visits) without any intervention, in order to establish practice-effect benchmarks independent of neuromodulation, cognitive training, or mood symptomatology - a design feature intended to isolate true intervention effects from repeated-testing effects, consistent with methodological recommendations for cognitive intervention trials in serious mental illness.
Primary outcomes include change over time in behavioral (d' on Affective and non-affective Go/NoGo and Dot Pattern Expectancy tasks; Trail Making Test-B completion time) and EEG (frontal theta amplitude during the Monetary Incentive Delay task; error-related positivity during the Go/NoGo task) indices of CC, comparing active versus sham tACS groups relative to the practice-effect benchmark established by the control cohort. Secondary outcomes include self-report CC measures (UPPS-P, MPQ-BF Control subscale), qualitative acceptability data from semi-structured exit interviews with the BD cohort, and cross-sectional associations between baseline CC indices and lifetime severity of (hypo)mania, depression, and suicidality. Exploratory analyses will examine intervention effects on general cognitive functioning and the influence of subthreshold mood symptoms on treatment response.
This study is the first to test remotely delivered tACS combined with cognitive training in Veterans with BD, and is designed to establish feasibility, acceptability, and preliminary efficacy data to inform future trials examining long-term effects on BD illness course, including suicidality and functional outcomes.
- Conditions
- Bipolar Disorder, Bipolar and Related Disorders, Veterans, Suicide, Suicidal Ideation, Mental Disorders
- Being tested
- Soterix 1x1 tES mini-CT
- Keywords
- Transcranial Direct Current Stimulation, Electric Stimulation Therapy, Cognitive Remediation, Cognitive Training, Executive Function, Cognition, Inhibition, Psychological, Impulsive Behavior, Electroencephalography, Randomized Controlled Trial, Double-Blind Method, Telemedicine, Neuropsychological Tests
- Medical subject headings
- Bipolar Disorder, Bipolar and Related Disorders, Suicide, Suicidal Ideation, Mental Disorders, Inhibition, Psychological, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soterix 1x1 tES mini-CTDevice
Also called Soterix Medical Remote Neuromodulation
The Soterix 1x1 tES mini-CT is a compact, battery-powered transcranial electrical stimulation device manufactured by Soterix Medical, Inc., designed to deliver low-intensity electrical current (including tDCS and tACS waveforms) through scalp electrodes for research use. The device is part of Soterix's Remote Neuromodulation platform, specifically engineered to support safe, self-administered stimulation in the home setting under remote supervision. It is used in conjunction with the SNAPstrap headgear and SNAPpad electrodes for standardized, simplified electrode placement, and is programmed via subject- and session-specific, one-time-use activation codes that pre-set stimulation parameters (intensity, duration, and active/sham condition), preventing participant alteration of stimulation settings. The device is labeled by the manufacturer for investigational use only under U.S. federal law.
| Study group | Role | What they receive |
|---|---|---|
| Active transcranial alternating current stimulation (tACS)+ Cognitive Training | Experimental | Veterans with bipolar disorder randomized to this arm receive 10 sessions of active frontal theta-frequency transcranial alternating current stimulation (tACS; 5Hz, 1mA, delivered via electrodes at F3/F4), administered concurrently with computerized cognitive training (BrainHQ) targeting working memory, inhibitory control, set-shifting, and attention. Sessions are self-administered at home under real-time remote supervision. Receives: Device: Soterix 1x1 tES mini-CT |
| Sham transcranial alternating current stimulation (tACS)+ Cognitive Training | Placebo comparator | Veterans with bipolar disorder randomized to this arm receive 10 sessions of sham (inactive) tACS, using identical electrode placement, session structure, and setup as the active arm, but without sustained active current delivery beyond a brief onset sensation. This arm receives the same concurrent cognitive training (BrainHQ) as the active arm, allowing isolation of tACS-specific effects beyond cognitive training alone. Receives: Device: Soterix 1x1 tES mini-CT |
| Control (No Intervention) | No intervention | Veterans without major psychopathology complete the same baseline and follow-up assessment schedule (self-report, behavioral, and EEG measures of cognitive control) as the BD cohort, without receiving cognitive training, tACS, or sham tACS. This arm establishes practice-effect benchmarks to distinguish true intervention effects from repeated-testing effects. This arm is assigned by eligibility status, not randomization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Affective Go/NoGo task
The Affective Go/NoGo task assesses response inhibition within an emotionally salient context, in contrast to purely non-affective measures of cognitive control. On each trial, a word with positive, negative, or neutral emotional valence is presented at the center of the screen; participants are instructed to respond as quickly as possible to target words of a designated valence (e.g., positive) while withholding responses to distractor words of the other two valences (e.g., negative or neutral). This design requires participants to inhibit prepotent responses to emotionally salient but task-irrelevant stimuli, capturing the interaction between affective processing and cognitive control. Affective response inhibition will be indexed by overall task accuracy using d', consistent with signal detection approaches to response inhibition performance.
Measured: Baseline (Week 0), Week 3 Follow-Up, Week 10 Follow-Up
Dot Pattern Expectancy (DPX) task
The Dot Pattern Expectancy (DPX) is a dot-based variant of the AX-Continuous Performance Test (AX-CPT) used to assess cognitive control in the context of proactive response preparation and contextual updating. On each trial, participants are presented with a cue (white) followed by a probe (light blue), separated by a 2500-3500 ms interval; a target response is required only when a valid cue ("A") is followed by a valid probe ("X"), yielding four trial types: AX (target), AY, BX, and BY (nontarget). The outcome measure is overall task accuracy, calculated using the discriminability index (d'), a signal detection measure calculated as the z-transformed hit rate minus the z-transformed false alarm rate, adjusted for performance. The d' score is a continuous measure with a range of -4 to 4; higher d' scores indicate better discrimination between target and non-target trials, reflecting stronger cognitive control.
Measured: Baseline (Week 0), Week 3 Follow-Up, Week 10 Follow-Up
Trail Making Test-B (TMT-B)
The Trail Making Test-B (TMT-B) is a widely used, paper-and-pencil neuropsychological measure of cognitive flexibility and set-shifting. Participants are asked to draw a line connecting a series of numbered and lettered circles in alternating sequential order (e.g., 1-A-2-B-3-C), as quickly and accurately as possible. Because successful performance requires continuously shifting attention between two different response sets, TMT-B is considered a sensitive index of executive/cognitive control, with longer completion times reflecting greater difficulty in adaptive, flexible responding. The primary outcome measure is time to completion.
Measured: Baseline (Week 0), Week 3 Follow-Up, Week 10 Follow-Up
Go/NoGo task
EEG will be recorded during a Go/NoGo task in which participants are instructed to respond via button press to any letter other than "X" (Go trials) and to withhold response when an "X" appears (NoGo trials), while responding as quickly as possible and minimizing errors. Participants complete two blocks totaling 228 trials, with approximately 24% designated as NoGo trials; letters are presented for 2000 ms with a randomized intertrial interval of 800-1200 ms. Because Go trials occur more frequently than NoGo trials, the task design induces a prepotent tendency to respond, increasing demand on inhibitory control during NoGo trials. Behavioral accuracy will be indexed by d'. The primary neural outcome of interest is the event-related potential (ERP) time-locked to the button-press response reflecting conscious error detection, indexed by error-related positivity (Pe) amplitude.
Measured: Baseline (Week 0), Week 3 Follow-Up, Week 10 Follow-Up
Monetary Incentive Delay (MID) task
The Monetary Incentive Delay (MID) task assesses neural responses associated with anticipating and receiving monetary outcomes. Participants complete 180 trials across three blocks; each trial begins with a 250 ms cue indicating a potential gain, loss, or neutral outcome, denoted by line markings corresponding to magnitude ($0.25-$5.00). Following a 1,500 ms fixation period, a brief target (180-280 ms) appears, requiring a speeded button press to win or avoid losing money; target duration is adaptively titrated to maintain approximately 70% accuracy across participants. Trial outcome feedback is presented for 1,650 ms, followed by a 500 ms display of cumulative earnings, and participants are compensated with a portion of their total winnings at the conclusion of the task. EEG is recorded continuously throughout the task, with frontal theta power during the reward anticipation period serving as the primary neural outcome measure.
Measured: Baseline (Week 0), Week 3 Follow-Up, Week 10 Follow-Up
Secondary outcomes (3)
UPPS-P Impulsive Behavior Scale
The UPPS-P is a self-report measure conceptualizing impulsivity as a multi-faceted, multi-dimensional construct comprising five distinct trait subscales: Negative Urgency (tendency to act rashly during negative emotions), Lack of Premeditation (tendency to act without forethought), Lack of Perseverance (inability to remain focused on a task), Sensation Seeking (tendency to pursue novel and thrilling experiences), and Positive Urgency (tendency to act rashly during positive emotions). This study will use the 20-item short-form version of the UPPS-P, which has demonstrated high reliability and validity.
Measured: Baseline (Week 0), Week 3 Follow-Up, Week 10 Follow-Up
MPQ-BF
The MPQ-BF is a self-report personality assessment comprising 11 primary trait scales that load onto three higher-order temperament factors. This study will use the Control primary scale, which assesses trait impulsivity related primarily to response inhibition and lack of premeditation, as a self-report index of cognitive control.
Measured: Baseline (Week 0), Week 3 Follow-Up, Week 10 Follow-Up
Exit Interview
A semi-structured exit interview will be administered to participants in the bipolar disorder (BD) cohort to assess acceptability of the combined tACS and cognitive training protocol and to inform future clinical implementation. The interview will assess participants' perceptions of each intervention component (tACS and cognitive training), including perceived benefits and concerns, suggestions for protocol modifications to enhance future benefit, and likelihood of recommending the intervention to other Veterans. All participants in the BD group will be approached for the exit interview, including those who do not complete all 10 intervention sessions, in order to capture factors contributing to low adherence; responses will be compared between active and sham tACS conditions to help distinguish concerns specific to the neuromodulation approach from those related to the cognitive training or overall study protocol.
Measured: Week 10 Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start1 Jun 2027 (estimated)
- Primary completion31 Mar 2031 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Parallel groups
- Model description
- This study uses a parallel-group design. Veterans with bipolar disorder (BD) are randomized 1:1 to receive either active or sham frontal theta-frequency transcranial alternating current stimulation (tACS), with both groups receiving concurrent cognitive training over 10 sessions; these two groups are followed and assessed in parallel throughout the intervention and follow-up periods. A third, non-randomized parallel arm of Veterans without major psychopathology completes the identical baseline and follow-up assessment schedule without any intervention, serving as a practice-effect comparison group run concurrently with the two randomized BD arms.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Casey S Gilmore, PhD, Principal investigator, Minneapolis VA Health Care System, Minneapolis, MN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845409
- Sponsor's protocol ID
- MHBC-004-26S
- Acronym
- TACTIC-BD
- Status last verified
- Sep 2026
- First submitted
- 9 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeted Alternating Current and Cognitive Training Intervention for Cognitive Control in Bipolar Disorders (TACTIC-BD)
- ClinicalTrials.gov ID
- NCT07845409
- Acronym / sponsor ID
- TACTIC-BD / MHBC-004-26S
- Conditions
- Bipolar Disorder, Bipolar and Related Disorders, Veterans, Suicide, Suicidal Ideation, Mental Disorders
- Keywords
- Transcranial Direct Current Stimulation, Electric Stimulation Therapy, Cognitive Remediation, Cognitive Training, Executive Function, Cognition, Inhibition, Psychological, Impulsive Behavior
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jun 2027 (estimated)
- Primary completion
- 31 Mar 2031 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is testing whether a type of gentle brain stimulation, combined with computer-based brain training exercises, can help improve thinking skills in Veterans with bipolar disorder. Veterans with bipolar disorder may have difficulty with skills like stopping to think before acting or adjusting their behavior when things change - problems that can affect daily life and have been linked to a higher risk of serious outcomes.
In this study, Veterans with bipolar disorder will complete brain training exercises at home on a computer, paired with a mild electrical brain stimulation called transcranial alternating current stimulation (tACS), delivered through a small headband worn on the forehead. Some participants will receive real stimulation and some will receive an inactive ("sham") version, and neither participants nor most study staff will know which one a person is receiving. All participants will also complete brain wave recordings (EEG), interviews, questionnaires, and various thinking tasks before and after the study to measure any changes. A separate group of Veterans without bipolar disorder will complete the same tests, without any brain stimulation or training, to help researchers understand how much change would happen naturally just from taking the same tests more than once.
The goal of this research is to learn whether this combined treatment approach is safe, tolerable, and helpful for improving thinking skills in Veterans with bipolar disorder, and whether Veterans find it an acceptable treatment worth continuing.
Detailed description
Veterans with bipolar disorder (BD) are at elevated risk for suicide, recurrent homelessness, and disability, and existing pharmacological and psychosocial treatments show limited efficacy for the cognitive dysfunction that underlies these outcomes. Cognitive control (CC) - encompassing response inhibition, error monitoring, and adaptive responding to changing contingencies - is a core, trait-like neurocognitive deficit in BD that persists across mood states (mania, depression, euthymia) and is mechanistically linked to symptom severity and suicidality. No prior studies have examined neuromodulation targeting CC processes in Veterans with BD.
This study is a randomized, double-blind, sham-controlled trial testing whether transcranial alternating current stimulation (tACS) targeting frontal theta oscillations, delivered concurrently with CC-relevant cognitive training, improves neural and behavioral indices of CC beyond cognitive training alone. Ninety-two Veterans with a DSM-5 diagnosis of Bipolar I, Bipolar II, or Other Specified Bipolar Disorder will complete a baseline assessment battery, including self-report measures, EEG (resting-state and task-based), and behavioral paradigms indexing CC in both affective and non-affective contexts (e.g., Go/NoGo, Dot Pattern Expectancy, Monetary Incentive Delay tasks). Participants will then be randomized 1:1 to 10 sessions of active (5Hz, 1mA) or sham frontal theta-frequency tACS (electrodes at F3/F4), each paired with concurrent computerized cognitive training (BrainHQ) targeting working memory, inhibitory control, set-shifting, and attention. All intervention sessions will be self-administered in participants' homes under real-time remote supervision via videoconference. Follow-up assessments repeating the baseline CC battery will occur at approximately 1-week and 2-months post-intervention.
An additional 46 Veterans without major psychopathology will complete an identical assessment schedule (baseline and two follow-up visits) without any intervention, in order to establish practice-effect benchmarks independent of neuromodulation, cognitive training, or mood symptomatology - a design feature intended to isolate true intervention effects from repeated-testing effects, consistent with methodological recommendations for cognitive intervention trials in serious mental illness.
Primary outcomes include change over time in behavioral (d' on Affective and non-affective Go/NoGo and Dot Pattern Expectancy tasks; Trail Making Test-B completion time) and EEG (frontal theta amplitude during the Monetary Incentive Delay task; error-related positivity during the Go/NoGo task) indices of CC, comparing active versus sham tACS groups relative to the practice-effect benchmark established by the control cohort. Secondary outcomes include self-report CC measures (UPPS-P, MPQ-BF Control subscale), qualitative acceptability data from semi-structured exit interviews with the BD cohort, and cross-sectional associations between baseline CC indices and lifetime severity of (hypo)mania, depression, and suicidality. Exploratory analyses will examine intervention effects on general cognitive functioning and the influence of subthreshold mood symptoms on treatment response.
This study is the first to test remotely delivered tACS combined with cognitive training in Veterans with BD, and is designed to establish feasibility, acceptability, and preliminary efficacy data to inform future trials examining long-term effects on BD illness course, including suicidality and functional outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This study uses a parallel-group design. Veterans with bipolar disorder (BD) are randomized 1:1 to receive either active or sham frontal theta-frequency transcranial alternating current stimulation (tACS), with both groups receiving concurrent cognitive training over 10 sessions; these two groups are followed and assessed in parallel throughout the intervention and follow-up periods. A third, non-randomized parallel arm of Veterans without major psychopathology completes the identical baseline and follow-up assessment schedule without any intervention, serving as a practice-effect comparison group run concurrently with the two randomized BD arms.
| Arm | Type | Receives |
|---|---|---|
| Active transcranial alternating current stimulation (tACS)+ Cognitive Training | Experimental | Device: Soterix 1x1 tES mini-CTVeterans with bipolar disorder randomized to this arm receive 10 sessions of active frontal theta-frequency transcranial alternating current stimulation (tACS; 5Hz, 1mA, delivered via electrodes at F3/F4), administered concurrently with computerized cognitive training (BrainHQ) targeting working memory, inhibitory control, set-shifting, and attention. Sessions are self-administered at home under real-time remote supervision. |
| Sham transcranial alternating current stimulation (tACS)+ Cognitive Training | Placebo comparator | Device: Soterix 1x1 tES mini-CTVeterans with bipolar disorder randomized to this arm receive 10 sessions of sham (inactive) tACS, using identical electrode placement, session structure, and setup as the active arm, but without sustained active current delivery beyond a brief onset sensation. This arm receives the same concurrent cognitive training (BrainHQ) as the active arm, allowing isolation of tACS-specific effects beyond cognitive training alone. |
| Control (No Intervention) | No intervention | –Veterans without major psychopathology complete the same baseline and follow-up assessment schedule (self-report, behavioral, and EEG measures of cognitive control) as the BD cohort, without receiving cognitive training, tACS, or sham tACS. This arm establishes practice-effect benchmarks to distinguish true intervention effects from repeated-testing effects. This arm is assigned by eligibility status, not randomization. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Veteran
- Capacity to provide voluntary informed consent
- English language fluency
- Stable dose of prescription and non-prescription medications that may impact cognition for at least 3 weeks prior to consent
- Bipolar Disorder (BD) cohort only: A primary diagnosis of Bipolar I Disorder, Bipolar II Disorder, or Other Specified Bipolar Disorder (i.e., those with major depressive episodes and hypomania that meet all episode criteria but for duration)
Key exclusion criteria (9 listed)
- Presence of a medical, psychiatric, physical or non-physical disease, disorder, condition, injury, disability or pre-existent history such that study participation, in the opinion of the study investigators: a) May pose a significant risk to the participant, b) raises the possibility that the participant is unlikely to successfully complete all the requirements of the study according to the study protocol, or c) might adversely impact the integrity of the data or the validity of the study results. Specific conditions may include (but are not limited to) a history of brain tumor near the stimulation site, brain surgery, severe traumatic brain injury (TBI) (LOC >24 hours, GCS 3-8), stroke with current sequalae, epilepsy, Multiple Sclerosis, Huntington's Disease, ALS, ataxia, aphasia, Alzheimer's Disease, dementia, cardiac pacemaker or defibrillator, blindness, or deafness.
- Bipolar Disorder (BD) cohort only: a) Current/acute episode criteria met for any Bipolar Disorder (BD) episode (i.e., hypomania, mania, depression) for the month prior to consent as assessed by SCID-5-RV's Module A, b) Current/acute substance use disorder with severe specifier and/or evidence of withdrawal or increased tolerance, as assessed by SCID-5-RV's Module E, c) Contraindications for transcranial alternating current stimulation (tACS), e.g., metallic cranial or facial implant, dermatologic conditions on the forehead, etc. d) No or limited internet connection in their home
- Control cohort only: a) Current or lifetime bipolar disorders or symptoms of psychosis assessed by SCID-5-RV, and/or b) Clinically significant mental health disorders within 2 years of consent (e.g., major depressive disorder, generalized anxiety disorder, post-traumatic stress disorder, substance use disorder as specified in 2b) as assessed by SCID-5-RV
- Court-appointed legal guardianship
- Cognitive training or neuromodulation treatments for clinical or research purposes within 30 days of consent or during study period (consent to final follow-up)
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 |
|---|---|---|
| Soterix 1x1 tES mini-CTAlso: Soterix Medical Remote NeuromodulationThe Soterix 1x1 tES mini-CT is a compact, battery-powered transcranial electrical stimulation device manufactured by Soterix Medical, Inc., designed to deliver low-intensity electrical current (including tDCS and tACS waveforms) through scalp electrodes for research use. The device is part of Soterix's Remote Neuromodulation platform, specifically engineered to support safe, self-administered stimulation in the home setting under remote supervision. It is used in conjunction with the SNAPstrap headgear and SNAPpad electrodes for standardized, simplified electrode placement, and is programmed via subject- and session-specific, one-time-use activation codes that pre-set stimulation parameters (intensity, duration, and active/sham condition), preventing participant alteration of stimulation settings. The device is labeled by the manufacturer for investigational use only under U.S. federal law. | Device | Active transcranial alternating current stimulation (tACS)+ Cognitive Training, Sham transcranial alternating current stimulation (tACS)+ Cognitive Training |
Primary outcome
Affective Go/NoGo task
Time frame: Baseline (Week 0), Week 3 Follow-Up, Week 10 Follow-Up
The Affective Go/NoGo task assesses response inhibition within an emotionally salient context, in contrast to purely non-affective measures of cognitive control. On each trial, a word with positive, negative, or neutral emotional valence is presented at the center of the screen; participants are instructed to respond as quickly as possible to target words of a designated valence (e.g., positive) while withholding responses to distractor words of the other two valences (e.g., negative or neutral). This design requires participants to inhibit prepotent responses to emotionally salient but task-irrelevant stimuli, capturing the interaction between affective processing and cognitive control. Affective response inhibition will be indexed by overall task accuracy using d', consistent with signal detection approaches to response inhibition performance.
Dot Pattern Expectancy (DPX) task
Time frame: Baseline (Week 0), Week 3 Follow-Up, Week 10 Follow-Up
The Dot Pattern Expectancy (DPX) is a dot-based variant of the AX-Continuous Performance Test (AX-CPT) used to assess cognitive control in the context of proactive response preparation and contextual updating. On each trial, participants are presented with a cue (white) followed by a probe (light blue), separated by a 2500-3500 ms interval; a target response is required only when a valid cue ("A") is followed by a valid probe ("X"), yielding four trial types: AX (target), AY, BX, and BY (nontarget). The outcome measure is overall task accuracy, calculated using the discriminability index (d'), a signal detection measure calculated as the z-transformed hit rate minus the z-transformed false alarm rate, adjusted for performance. The d' score is a continuous measure with a range of -4 to 4; higher d' scores indicate better discrimination between target and non-target trials, reflecting stronger cognitive control.
Trail Making Test-B (TMT-B)
Time frame: Baseline (Week 0), Week 3 Follow-Up, Week 10 Follow-Up
The Trail Making Test-B (TMT-B) is a widely used, paper-and-pencil neuropsychological measure of cognitive flexibility and set-shifting. Participants are asked to draw a line connecting a series of numbered and lettered circles in alternating sequential order (e.g., 1-A-2-B-3-C), as quickly and accurately as possible. Because successful performance requires continuously shifting attention between two different response sets, TMT-B is considered a sensitive index of executive/cognitive control, with longer completion times reflecting greater difficulty in adaptive, flexible responding. The primary outcome measure is time to completion.
Go/NoGo task
Time frame: Baseline (Week 0), Week 3 Follow-Up, Week 10 Follow-Up
EEG will be recorded during a Go/NoGo task in which participants are instructed to respond via button press to any letter other than "X" (Go trials) and to withhold response when an "X" appears (NoGo trials), while responding as quickly as possible and minimizing errors. Participants complete two blocks totaling 228 trials, with approximately 24% designated as NoGo trials; letters are presented for 2000 ms with a randomized intertrial interval of 800-1200 ms. Because Go trials occur more frequently than NoGo trials, the task design induces a prepotent tendency to respond, increasing demand on inhibitory control during NoGo trials. Behavioral accuracy will be indexed by d'. The primary neural outcome of interest is the event-related potential (ERP) time-locked to the button-press response reflecting conscious error detection, indexed by error-related positivity (Pe) amplitude.
Monetary Incentive Delay (MID) task
Time frame: Baseline (Week 0), Week 3 Follow-Up, Week 10 Follow-Up
The Monetary Incentive Delay (MID) task assesses neural responses associated with anticipating and receiving monetary outcomes. Participants complete 180 trials across three blocks; each trial begins with a 250 ms cue indicating a potential gain, loss, or neutral outcome, denoted by line markings corresponding to magnitude ($0.25-$5.00). Following a 1,500 ms fixation period, a brief target (180-280 ms) appears, requiring a speeded button press to win or avoid losing money; target duration is adaptively titrated to maintain approximately 70% accuracy across participants. Trial outcome feedback is presented for 1,650 ms, followed by a 500 ms display of cumulative earnings, and participants are compensated with a portion of their total winnings at the conclusion of the task. EEG is recorded continuously throughout the task, with frontal theta power during the reward anticipation period serving as the primary neural outcome measure.
3 secondary outcomes
UPPS-P Impulsive Behavior Scale
Time frame: Baseline (Week 0), Week 3 Follow-Up, Week 10 Follow-Up
MPQ-BF
Time frame: Baseline (Week 0), Week 3 Follow-Up, Week 10 Follow-Up
Exit Interview
Time frame: Week 10 Follow-Up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- 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.
Casey S Gilmore, PhD principal investigator
Minneapolis VA Health Care System, Minneapolis, MN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soterix 1x1 tES mini-CT in people with Bipolar Disorder and Bipolar and Related Disorders, run by VA Office of Research and Development 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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 28 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Casey S Gilmore, PhD ((612) 725-2000 ext. 312051, Casey.Gilmore2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Affective Go/NoGo task (time frame: Baseline (Week 0), Week 3 Follow-Up, Week 10 Follow-Up). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2026; AzTrials last refreshed its copy on 26 Oct 2026.