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.
1
University of Wisconsin
Madison, Wisconsin, United States, 53706