Stimulating After Recovery From Traumatic Brain Injury

NCT ID: NCT05327829

Last Updated: 2025-03-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2028-01-15

Brief 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.

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.

Conditions

TBI (Traumatic Brain Injury)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Sham

No stimulation

Group Type: SHAM_COMPARATOR

COGED

Intervention Type: 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).

Stimulation

Stimulation

Group Type: ACTIVE_COMPARATOR

External non-invasive stimulation

Intervention Type: 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

Intervention Type: 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).

Interventions

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.

Intervention Type: COMBINATION_PRODUCT

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

Uniformed Services University of the Health Sciences

FED

Sponsor Role: collaborator

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Darrow, MD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

Hennepin County Medical Center

Minneapolis, Minnesota, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

David Darrow, MD

Role: CONTACT

Darro015@umn.edu

612-873-7481

David Darrow, MD

Role: CONTACT

darro015@umn.edu

Facility Contacts

David Darrow, MD MPH

Role: primary

Darro015@umn.edu

612-873-7481

Study Coordinator

Role: backup

tnash@hhrinstitute.org

612-873-7481

Other Identifiers

IRB-FY2023-678

Identifier Type: -

Identifier Source: org_study_id