About this trial
Using the CorTec Brain Interchange (BIC) System, we will examine the effect of a plasticity-inducing therapy regime on the rehabilitation of upper limb impairment post-stroke. This study's main objective is to implement and evaluate neuroplasticity-inducing stimulation. The stimulation methods for inducing neuroplasticity have been selected based on prior preclinical and intraoperative work that has shown promise in providing rehabilitative benefits for stroke patients. We will be structuring this study as an open prospective feasibility study.
Eligibility criteria
Qualifiers
History of ischemic stroke
Minimum 6 months post-ischemic cortical stroke
Levels of hemiparesis that warrant surgical intervention (upper limb impairment)
Able to participate in a meaningful way in rehabilitation (defined by upper extremity Fugl-Myer (UEFM) score of 25-45
Disqualifiers
Unable to discontinue anti-platelet medication for 7 days pre- and 3 days post-op
On therapeutic anticoagulation
A history of unprovoked deep vein thrombosis or any pulmonary embolus
The presence of a bleeding disorder which significantly increases the chances that the patient will have a hemorrhagic complication in relation to study procedures.
Trial design
Treatments tested in this trial
- CorTec Brain Interchange (BIC) System
Treatment groups
Sponsors and collaborators
University of Washington
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator