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NCT Number: NCT05327829

Stimulating After Recovery From Traumatic Brain Injury

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location status: Recruiting

Location contact

David Darrow, MD MPH

CONTACT

[email protected]

612-873-7481

David Darrow, MD MPH

SUB_INVESTIGATOR

Samual Cramer, MD, PhD

PRINCIPAL_INVESTIGATOR

Study Coordinator

CONTACT

[email protected]

612-873-7481

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

External non-invasive stimulation

Combination Product

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

Behavioral

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 outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

David Darrow, MD

CONTACT

[email protected]

612-873-7481

David Darrow, MD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Uniformed Services University of the Health Sciences
  • United States Department of Defense

Registry information

Acronym: SMART

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 14, 2022
Registry last updated
Apr 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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