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Stimulating After Recovery From Traumatic Brain Injury (SMART)

Primary Purpose

TBI (Traumatic Brain Injury)

Status

Not yet recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

External non-invasive stimulation

COGED

About this trial

This is an interventional other trial for TBI (Traumatic Brain Injury)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

Hennepin County Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Sham

Stimulation

Arm Description

No stimulation

Stimulation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05327829

First Posted

February 28, 2022

Last Updated

October 15, 2022

Sponsor

University of Minnesota

1. Study Identification

Unique Protocol Identification Number

NCT05327829

Brief Title

Stimulating After Recovery From Traumatic Brain Injury

Acronym

SMART

Official Title

Stimulating After Recovery From Traumatic Brain Injury

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

September 15, 2023 (Anticipated)

Primary Completion Date

September 1, 2025 (Anticipated)

Study Completion Date

September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

Brief 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.

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/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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

TBI (Traumatic Brain Injury)

7. Study Design

Primary Purpose

Other

Study Phase

Early Phase 1

Interventional Study Model

Parallel Assignment

Model Description

Block design

Masking

Participant

Masking Description

Participants are blinded to stimulation versus no stimulation.

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sham

Arm Type

Sham Comparator

Arm Description

No stimulation

Arm Title

Stimulation

Arm Type

Active Comparator

Arm Description

Stimulation

Intervention Type

Combination Product

Intervention Name(s)

External non-invasive stimulation

Intervention Description

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.

Intervention Type

Behavioral

Intervention Name(s)

COGED

Intervention Description

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).

Primary Outcome Measure Information:

Title

Feasibility of using non-invasive stimulation to improve Cognitive Flexibility after TBI

Description

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David Darrow, MD

Phone

612-873-7481

Darro015@umn.edu

First Name & Middle Initial & Last Name or Official Title & Degree

David Darrow, MD

darro015@umn.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David Darrow, MD

Organizational Affiliation

University of Minnesota

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hennepin County Medical Center

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55415

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

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Stimulating After Recovery From Traumatic Brain Injury

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