RecruitingEarly Phase 1NCT05327829

Stimulating After Recovery From Traumatic Brain Injury


Sponsor

University of Minnesota

Enrollment

30 participants

Start Date

Mar 31, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria10

  • 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 Criteria13

  • 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
  • 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

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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).


Locations(1)

Hennepin County Medical Center

Minneapolis, Minnesota, United States

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NCT05327829


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