A Closed Loop Neural Activity Triggered Stroke Rehabilitation Device

Launched by UNIVERSITY OF WISCONSIN, MADISON · Mar 24, 2014

Keywords

ClinConnect Summary

This clinical trial is investigating two non-invasive brain stimulation techniques to see if they can help improve recovery for stroke patients who have difficulties with their arm movement. The study will involve muscle stimulation of the arm and neuro-stimulation through the tongue. The goal is to find out if these methods can lead to better recovery outcomes for those affected by stroke.

To participate, patients must be between the ages of 65 and 74 and have had a stroke that has left them with ongoing issues using their arms. There are also control groups that include stroke patients without arm issues, those with risk factors for stroke, and healthy individuals. Participants can expect to undergo various tests and receive treatment to help assess the effectiveness of the techniques being studied. It’s important to note that certain individuals, such as those who are pregnant or have specific allergies or medical conditions, will not be eligible for the trial.

Gender

ALL

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.