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

Conditions

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

Eligibility Criteria

Sex

ALL

Age

21 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Soterix 1x1 tES mini-CT — DEVICE
  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.

Study Details

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.

Key Dates

First listed

Sep 28, 2026

Start date

Jun 1, 2027

Status verified

Sep 2026

Primary completion

Mar 31, 2031

Completion

Mar 31, 2031

Study Design

Enrollment

138 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Active transcranial alternating current stimulation (tACS)+ Cognitive Training
  Veterans 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.
• Placebo Comparator: Sham transcranial alternating current stimulation (tACS)+ Cognitive Training
  Veterans 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.
• No Intervention: Control (No Intervention)
  Veterans 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.

Primary Outcome Measure

Affective Go/NoGo task [ Time Frame: Baseline (Week 0), Week 3 Follow-Up, Week 10 Follow-Up ]

Central Contacts

• Casey S Gilmore, PhD
  (612) 725-2000
  [email protected]
• Snezana Urosevic, PhD
  (612) 467-3897
  [email protected]

Locations (1)

Find similar trials in Minneapolis, MN

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