Stimulating After Recovery From Traumatic Brain Injury
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Recruiting
- Sponsor
- University of Minnesota
- Enrollment
- 30
- Locations
- 2
- Primary Endpoint
- Feasibility of using non-invasive stimulation to improve Cognitive Flexibility after TBI
Study Overview
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.
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 during the first three appointments or the last three appointments. While participating, both the tACS will be applied in accordance with the manufacturer's suggested use. Participants will complete computer-based tasks, while taking part in either the sham or tACS stimulation. The study is investigating the use of neuromodulation after Traumatic Brain Injury (TBI) for improved cognitive function.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Masking Description
Participants are blinded to stimulation versus no stimulation.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Feasibility of using non-invasive stimulation to improve Cognitive Flexibility after TBI
Time Frame: 3 years
Using non-invasive transcranial alternating current stimulation, it will be determined if this study is feasible for improving cognitive recovery after mild to moderate brain injury. To determine the sum total of completion rate of study procedures.
Secondary Outcomes
No secondary outcomes reported