Status:
RECRUITING
Stimulating After Recovery From Traumatic Brain Injury
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
United States Department of Defense
Uniformed Services University of the Health Sciences
Conditions:
TBI (Traumatic Brain Injury)
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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 co...
Detailed Description
All participants engaged in the study will participate once weekly for six weeks at Hennepin Healthcare Systems, Inc. (HHS). Each participant will be randomized into the block design of sham or tACS d...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2028
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05327829
Start Date
January 15 2025
End Date
January 15 2028
Last Update
March 17 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hennepin County Medical Center
Minneapolis, Minnesota, United States, 55415