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.
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
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
Parallel
Soterix 1x1 tES mini-CT
DeviceThe 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.
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.
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.
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.
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.
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.
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.
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.
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