Targeted Alternating Current and Cognitive Training Intervention for Cognitive Control in Bipolar Disorders
TACTIC-BD
1 other identifier
interventional
138
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2027
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 9, 2026
CompletedFirst Posted
Study publicly available on registry
September 28, 2026
CompletedStudy Start
First participant enrolled
June 1, 2027
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2031
Study Completion
Last participant's last visit for all outcomes
March 31, 2031
September 28, 2026
September 1, 2026
3.8 years
September 9, 2026
September 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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.
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.
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.
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.
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.
Baseline (Week 0), Week 3 Follow-Up, Week 10 Follow-Up
Secondary Outcomes (3)
UPPS-P Impulsive Behavior Scale
Baseline (Week 0), Week 3 Follow-Up, Week 10 Follow-Up
MPQ-BF
Baseline (Week 0), Week 3 Follow-Up, Week 10 Follow-Up
Exit Interview
Week 10 Follow-Up
Study Arms (3)
Active transcranial alternating current stimulation (tACS)+ Cognitive Training
EXPERIMENTALVeterans 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 COMPARATORVeterans 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 INTERVENTIONVeterans 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Minneapolis VA Health Care System, Minneapolis, MN
Minneapolis, Minnesota, 55417-2309, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Casey S Gilmore, PhD
Minneapolis VA Health Care System, Minneapolis, MN
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- This study uses double-blind masking for the randomized comparison between active and sham tACS. Participants with bipolar disorder, study staff administering the intervention and conducting outcome assessments, and study investigators are all unaware of treatment assignment (active vs. sham), as both conditions use identical electrode setup, session structure, and device programming delivered via participant- and session-specific activation codes. An unblinded biostatistician and/or device programmer, who are not involved in participant assessment or clinical decision-making, will maintain the randomization key and generate the activation codes to preserve blinding among all other study personnel. Blinding integrity will be assessed at the end of the intervention period using a blinding questionnaire. The control cohort (Veterans without major psychopathology) is not blinded, as this group does not receive randomized intervention assignment.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2026
First Posted
September 28, 2026
Study Start (Estimated)
June 1, 2027
Primary Completion (Estimated)
March 31, 2031
Study Completion (Estimated)
March 31, 2031
Last Updated
September 28, 2026
Record last verified: 2026-09
Data Sharing
- IPD Sharing
- Will not share