VA Office of Research and Development
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.
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 neuromodu…
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, i…
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.