Stimulating After Recovery From Traumatic Brain Injury

Early Phase 1RecruitingNCT05327829

University of Minnesota30 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

Conditions

TBI (Traumatic Brain Injury)

Interventions

External non-invasive stimulationCOMBINATION_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.

COGEDBEHAVIORAL

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).

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Hennepin County Medical Center

Minneapolis, Minnesota, United States

RECRUITING

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

Central Contacts

David Darrow, MD

CONTACT

612-873-7481 Darro015@umn.edu

David Darrow, MD

CONTACT

darro015@umn.edu

Data from ClinicalTrials.gov

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