Using electrical stimulation to improve cognitive function after traumatic brain injury
Stimulating After Recovery From Traumatic Brain Injury
EARLY_PHASE1 · University of Minnesota · NCT05327829
This study is testing if a type of electrical stimulation can help adults recovering from mild to moderate brain injuries think better and make decisions more easily.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Minnesota (other) |
| Locations | 1 site (Minneapolis, Minnesota) |
| Trial ID | NCT05327829 on ClinicalTrials.gov |
What this trial studies
This preliminary interventional study aims to assess the feasibility of transcutaneous alternating current stimulation (TACS) in enhancing cognitive function and decision-making in adults recovering from mild to moderate traumatic brain injury (TBI). Participants will attend weekly sessions for six weeks at Hennepin Healthcare Systems, where they will be randomized to receive either TACS or a sham treatment during their sessions. The study will involve computer-based tasks to evaluate cognitive performance while undergoing stimulation. The goal is to explore the potential benefits of neuromodulation in TBI recovery.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a diagnosis of mild to moderate TBI who can complete computerized assessments.
Not a fit: Patients with severe TBI, open scalp wounds, or those unable to participate in computerized assessments may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved cognitive recovery and decision-making abilities for patients with traumatic brain injury.
How similar studies have performed: While this approach is novel, similar studies using neuromodulation techniques have shown promise in other cognitive rehabilitation contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults 18 years and older * Diagnosis of a mild to moderate TBI (GCS \> 8 on admission) * Able to perform a computerized assessment * Willing to attend all scheduled appointments * Able to undergo the informed consent process Healthy participants: * Adults 18 years and older * Able to perform a computerized assessment * Willing to attend all scheduled appointments * Able to undergo the informed consent process Exclusion Criteria: * Open wound on scalp * Severe TBI diagnosis or GCS of less than 8 on admission * Non-English speaking * Incarcerated * Implanted defibrillator or pacemaker * Visual impairment that hinders ability to complete computerized assessments Healthy subject exclusion criteria: * Less than 18 years of age * Open wound on scalp * TBI diagnosis * Non-English speaking * Incarcerated * Implanted defibrillator or pacemaker * Visual impairment that hinders ability to complete computerized assessments
Where this trial is running
Minneapolis, Minnesota
- Hennepin County Medical Center — Minneapolis, Minnesota, United States (RECRUITING)
Study contacts
- Principal investigator: David Darrow, MD — University of Minnesota
- Study coordinator: David Darrow, MD
- Email: Darro015@umn.edu
- Phone: 612-873-7481
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: TBI