NCT05327829 · University of Minnesota
Stimulating After Recovery From Traumatic Brain Injury
(SMART)
What this study is about
This is a preliminary, forward-looking 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.
View original scientific description
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.
Interventions
COMBINATION_PRODUCT
External 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.
BEHAVIORAL
COGED
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).
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Minneapolis, Minnesota
Collaborators
United States Department of Defense, Uniformed Services University of the Health Sciences
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 7, 2026 · Source of record for eligibility and locations