Stimulating After Recovery From Traumatic Brain Injury

ConditionTBI (Traumatic Brain Injury)

Trial statusRecruiting

Trial phaseEarly Phase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Minnesota

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Open wound on scalp

Severe TBI diagnosis or GCS of less than 8 on admission

Non-English speaking

Incarcerated

Trial design

Design model

Parallel

Treatments tested in this trial

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).

Treatment groups

30 Participants

are divided into 2 treatment groups

Group A: ShamSham comparator 1 intervention

Group B: StimulationActive comparator 2 interventions

Trial outcomes

Primary outcomes

Feasibility of using non-invasive stimulation to improve Cognitive Flexibility after TBI

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.

Time frame

3 years

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Minnesota

Lead sponsor

United States Department of Defense

Collaborator

Uniformed Services University of the Health Sciences

Collaborator

Source ClinicalTrials.gov

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