A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device
RecruitingHealthy volunteers welcome
Who can join
Ages 18 and older · All sexes · Healthy volunteers welcome
Full 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.
About the study
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 recovery.
What is being tested
- Functional Electric Stimulation (FES) (device)
- Behavioral Assessments (behavioral)
- Magnetic Resonance Imaging (other)
- EEG (other)
- RecoveriX (other)
- Delay (other)
Sponsor: University of Wisconsin, Madison · Participants: 288 · Started: 2010-06
Contact the study team
- Radiology Studies · Phone: 608-282-8349
Official record on ClinicalTrials.gov — NCT02098265
Locations in the U.S.
| Wisconsin | University of Wisconsin, Madison |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.