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NCT07845409

Targeted Alternating Current and Cognitive Training Intervention for Cognitive Control in Bipolar Disorders

Sponsor: VA Office of Research and Development

View on ClinicalTrials.gov

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.

Official title: Targeted Alternating Current and Cognitive Training Intervention for Cognitive Control in Bipolar Disorders (TACTIC-BD)

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

138

Start Date

2027-06-01

Completion Date

2031-03-31

Last Updated

2026-09-28

Healthy Volunteers

Yes

Conditions

Bipolar Disorder Bipolar and Related Disorders Veterans Suicide Suicidal Ideation Mental Disorders

Interventions

DEVICE

Soterix 1x1 tES mini-CT

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.

Inclusion Criteria: 1. Veteran 2. Capacity to provide voluntary informed consent 3. English language fluency 4. Stable dose of prescription and non-prescription medications that may impact cognition for at least 3 weeks prior to consent 5. 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) Exclusion Criteria: 1. 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. 2. 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 3. 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 4. Court-appointed legal guardianship 5. Cognitive training or neuromodulation treatments for clinical or research purposes within 30 days of consent or during study period (consent to final follow-up) 6. Electroconvulsive Therapy (ECT) within 12 months of consent or during study period 7. Baseline MoCA score \<18 or MoCA-Blind score \<19 8. Baseline acute severe suicidal ideation as determined by a score \> 3 on the Depressive Symptom Index-Suicidality Subscale (DSI-SS) 9. Positive pregnancy screen in participants of childbearing potential

Locations (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, United States