NCT07845409Not yet recruiting
Targeted Alternating Current and Cognitive Training Intervention for Cognitive Control in Bipolar Disorders
Targeted Alternating Current and Cognitive Training Intervention for Cognitive Control in Bipolar Disorders (TACTIC-BD)
Source: ClinicalTrials.gov · Last updated 28 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 138 (estimated)
- First submitted
- 9 Sept 2026
- Start date
- 1 Jun 2027
- Primary completion date
- 31 Mar 2031
- Lead sponsor
- VA Office of Research and Development
- Diseases
- Bipolar disorder
- NCT number
- NCT07845409
What you commit to
- Study type: Interventional
- Planned participants: 138
- From 1 Jun 2027 to the primary completion date, 31 Mar 2031
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- Electroconvulsive Therapy (ECT) within 12 months of consent or during study period
Other illness
- 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.
- 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
Other
- 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)
- 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
Who the study is looking for
- 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)
Age in the registry: 21 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Minneapolis VA Health Care System, Minneapolis, MN Coordinator of this site? Confirm its status | Minneapolis | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.