Stimulating After Recovery From Traumatic Brain Injury

Early Phase 1

Recruiting

• Conditions: TBI (Traumatic Brain Injury)
• Interventions: Combination Product: External non-invasive stimulation; Behavioral: COGED

• Registration Number: NCT05327829
• Lead Sponsor: University of Minnesota

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.

Study Timeline

• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-04-13
• Study First Posted: 2022-04-14
• Study Start: 2025-01-15
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-12
• Last Update Posted: 2025-03-17
• Primary Completion: 2028-01-15
• Study Completion: 2028-01-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stimulation	COGED	Stimulation
Stimulation	External non-invasive stimulation	Stimulation
Sham	COGED	No stimulation

Primary Outcome Measures

Name	Time	Method
Feasibility of using non-invasive stimulation to improve Cognitive Flexibility after TBI	3 years	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.

Trial Locations

Locations (1)

Hennepin County Medical Center; 🇺🇸 Minneapolis, Minnesota, United States