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NCT05327829EARLY_PHASE1RecruitingAccepts Healthy Volunteers

Stimulating After Recovery From Traumatic Brain Injury

University of Minnesota

Start Date

3/31/2025

Completion Date

1/15/2028

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

COMBINATION_PRODUCT

External non-invasive stimulation

BEHAVIORAL

COGED

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Conditions

TBI (Traumatic Brain Injury)

Locations

Hennepin County Medical Center

Minneapolis, Minnesota 55415

United States