Recruiting
Early Phase 1

Brain Stimulation

Sponsor:

University of Minnesota

Code:

NCT05327829

Conditions

TBI (Traumatic Brain Injury)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

External non-invasive stimulation

COGED

Study Details

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.

Conditions

TBI (Traumatic Brain Injury)

Study ID

NCT05327829

Start date

Mar 31, 2025

Status verified date

Apr, 2026

Completion date

Jan 15, 2028

Anticipated

Primary completion date

Jan 15, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

sham comparator: Sham

No stimulation

active comparator: Stimulation

Stimulation

Interventions

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.

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 measure

  • Feasibility of using non-invasive stimulation to improve Cognitive Flexibility after TBI [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

David Darrow, MD

612-873-7481Darro015@umn.edu

David Darrow, MD

darro015@umn.edu

Locations

Hennepin County Medical Center

Recruiting

Minneapolis, Minnesota, United States, 55415

Contacts

David Darrow, MD MPH

612-873-7481Darro015@umn.edu

Study Coordinator

612-873-7481tnash@hhrinstitute.org

Principal Investigator:

Samual Cramer, MD, PhD

More Information

Sponsor

University of Minnesota

Last update posted

Apr 7, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Minnesota on 2026-04-07.