Stimulating After Recovery From Traumatic Brain Injury (SMART)

University of Minnesota (UMN)

Status and phase: Begins enrollment this month; Early Phase 1

Conditions: TBI (Traumatic Brain Injury)

Treatments: Behavioral: COGED; Combination Product: External non-invasive stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT05327829

IRB-FY2023-678

Details and patient eligibility

About

This is a preliminary, prospective interventional study to investigate the feasibility of using transcutaneous alternating current stimulation (TACS) and transcutaneous noninvasive vagal nerve stimulation (tnVNS) after a traumatic brain injury (TBI) to improve cognitive function and decision-making.

Full 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/tnVNS during the first three appointments or the last three appointments. While participating, both the tACS and tnVNS 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/tnVNS stimulation. The study is investigating the use of neuromodulation after Traumatic Brain Injury (TBI) for improved cognitive function.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Sham

Sham Comparator group

Description:

No stimulation

Treatment:

Behavioral: COGED

Stimulation

Active Comparator group

Description:

Stimulation

Treatment:

Combination Product: External non-invasive stimulation

Behavioral: COGED