Status:

RECRUITING

A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device

Lead Sponsor:

University of Wisconsin, Madison

Collaborating Sponsors:

American Heart Association

Conditions:

Stroke

Eligibility:

All Genders

18+ years

Phase:

NA

Brief Summary

The purpose of this research is to determine if two non-invasive brain stimulation techniques, muscle stimulation of the arm and neuro-stimulation through the tongue, can increase the extent of stroke...

Detailed Description

The aim of this study is to determine if functional muscle stimulation, in addition to non-invasive neurostimulation through the tongue (TDU), directed by electroencephalogram (EEG) output, can increa...

Eligibility Criteria

Inclusion Criteria (Experimental Group):

  • Stroke patients with persistent upper extremity (UE) deficits

Inclusion Criteria (Control Group 1)

  • Stroke patients without UE impairments

  • Participants with risk factors for stroke

  • healthy controls

    • No known neurologic, psychiatric or developmental disability

Inclusion Criteria (Control Group 2)

  • Stroke patients with persistent upper extremity (UE) deficits
  • Moderate upper extremity (dominant right hand affected) impairment (score of 1 or 2 on the motor sub-component of the NIH stroke scale (NIHSS) and ARAT score 20-45)
  • No upper extremity injury or conditions that limited use prior to the stroke
  • Pre-stroke independence with a Modified Rankin Score of 0 or 1, for the standard FES only intervention.

Exclusion Criteria (for all participants):

  • Allergic to electrode gel, surgical tape and metals
  • Participants under treatment for infectious diseases or having apparent oral lesions or inflammation will be excluded from the study
  • Women who are pregnant or may become pregnant during the course of the study will be excluded
  • Participants with contraindications for MRI will be offered the opportunity to participate in the interventions study only (e.g. EEG-BCI-FES and behavioral testing)

Exclusion Criteria (for healthy controls)

  • Contraindications for MRI
  • Allergic to electrode gel, surgical tape, and metals.

Key Trial Info

Start Date :

June 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

June 1 2026

Estimated Enrollment :

288 Patients enrolled

Trial Details

Trial ID

NCT02098265

Start Date

June 1 2010

End Date

June 1 2026

Last Update

May 16 2025

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

University of Wisconsin

Madison, Wisconsin, United States, 53706