Stimulating After Recovery From Traumatic Brain Injury (SMART)

University of Minnesota (UMN) logo

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

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

Trial contacts and locations

1

Loading...

Central trial contact

David Darrow, MD; David Darrow, MD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems