Stimulating After Recovery From Traumatic Brain Injury

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
University of Minnesota
Study ID
NCT05327829
Phase
EARLY_PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • TBI (Traumatic Brain Injury)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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).

Study Details

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.

Key Dates

Start date
Mar 31, 2025
Status verified
Apr 2026
Primary completion
Jan 15, 2028
Completion
Jan 15, 2028

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Sham Comparator: Sham
    No stimulation
  • Active Comparator: Stimulation
    Stimulation

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hennepin County Medical CenterMinneapolisMinnesota55415
David Darrow, MD MPH
[email protected]
612-873-7481
Study Coordinator
[email protected]
612-873-7481
David Darrow, MD MPH (SUB_INVESTIGATOR)
Samual Cramer, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Minneapolis, MN

By research site
Hennepin County Medical Center· Minneapolis, MN

Related Studies