Stimulating After Recovery From Traumatic Brain Injury

TBI (Traumatic Brain Injury) Clinical Trial

— SMART  

Official title:

Stimulating After Recovery From Traumatic Brain Injury

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05327829
• Other study ID #: IRB-FY2023-678
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 30, 2024
• Est. completion date: June 30, 2027

Study information

• Verified date: June 2024
• Source: University of Minnesota
• Contact: David Darrow, MD
• Phone: 612-873-7481
• Email: Darro015[@]umn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: June 30, 2027
• Est. primary completion date: June 30, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• TBI (Traumatic Brain Injury)
• Wounds and Injuries

Intervention

Combination Product:
• External non-invasive stimulation
The participants are randomized into the block design of sham or tACS/tnVNS 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.

Behavioral:
• 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).

Locations

Country	Name	City	State
United States	Hennepin County Medical Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of using non-invasive stimulation to improve Cognitive Flexibility after TBI	Using non-invasive transcranial alternating current stimulation and transcutaneous non-invasive vagal nerve 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.	3 years