TBI (Traumatic Brain Injury)
Conditions
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.
Interventions
COMBINATION_PRODUCTExternal non-invasive stimulation
The participants are randomized into the block design of sham or tACS during the first three appointments or the last three appointments. Eye tracking will be used to test the predominant focus of decisions during the gaze phase on costs or difficulty levels during the COGED. The study is investigating the use of neuromodulation after TBI for improved cognitive function.
BEHAVIORALCOGED
The COGED task consists of the classic N-back task of working memory-based decision making, followed by a valuation phase. The N-back phase of the task allows calculation of cognitive performance of a working memory task. During valuation, participants receive titrating offers of differing amounts of money to perform different difficulty levels of the N-back. The result is an effort discounting curve used to measure the individual effort cost. Effort discounting curves show the perceived cognitive effort required to complete each level of the task relative to another (typically the 1-back).
Sponsors
University of Minnesota
United States Department of Defense
Uniformed Services University of the Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)
Masking description
Participants are blinded to stimulation versus no stimulation.
Intervention model description
Block design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of using non-invasive stimulation to improve Cognitive Flexibility after TBI | 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. |
Countries
United States
Contacts
CONTACTDavid Darrow, MD
PRINCIPAL_INVESTIGATORDavid Darrow, MD
University of Minnesota
Outcome results
None listed