NCT05327829 Stimulating After Recovery From Traumatic Brain Injury
| NCT ID | NCT05327829 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | University of Minnesota |
| Condition | TBI (Traumatic Brain Injury) |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2025-03-31 |
| Primary Completion | 2028-01-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2025-03-31 with a primary completion date of 2028-01-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a preliminary, prospective interventional study to investigate the feasibility of using transcutaneous alternating current stimulation (TACS) after a traumatic brain injury (TBI) to improve cognitive function and decision-making.
Eligibility 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
Contact & Investigator
David Darrow, MD
PRINCIPAL INVESTIGATOR
University of Minnesota
Frequently Asked Questions
Who can join the NCT05327829 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying TBI (Traumatic Brain Injury). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05327829 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05327829 currently recruiting?
Yes, NCT05327829 is actively recruiting participants. Contact the research team at Darro015@umn.edu for enrollment information.
Where is the NCT05327829 trial being conducted?
This trial is being conducted at Minneapolis, United States.
Who is sponsoring the NCT05327829 clinical trial?
NCT05327829 is sponsored by University of Minnesota. The principal investigator is David Darrow, MD at University of Minnesota. The trial plans to enroll 30 participants.