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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Phase
Early Phase 1
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Block design
Primary Purpose
Other
Masking
Single (Participant)
Masking Description
Participants are blinded to stimulation versus no stimulation.

Arm Groups

ArmDescriptionAssigned Intervention
Sham Comparator
Sham 		No stimulation
  • 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).
Active Comparator
Stimulation 		Stimulation
  • 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).

Recruiting Locations

Hennepin County Medical Center
Minneapolis, Minnesota 55415
Contact:
David Darrow, MD MPH
612-873-7481
Darro015@umn.edu

More Details

Status
Recruiting
Sponsor
University of Minnesota

Study Contact

David Darrow, MD
612-873-7481
Darro015@umn.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.