Motor Recovery Through Plasticity-Inducing Cortical Stimulation
ConditionStroke, Ischemic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22-75
SponsorUniversity of Washington
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
CorTec Brain Interchange (BIC) System
DeviceSurgical implantation of the BIC System. 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.
Treatment groups
4 Participants
are divided into 1 treatment groupGroup A: Motor Recovery through Plasticity-Inducing Cortical StimulationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Measuring upper limb impairment in stroke rehabilitation
The primary outcome measure in the study focus on measuring upper limb impairment to ensure that the use of the CorTec Brain Interchange system is not detrimental for use in studying stimulation paradigms to improve stroke rehabilitation. Limb impairment will be assessed for all patients weekly during the rehabilitation period and at all monthly post-rehab monitoring visits using the primary behavioral measures of the study, UEFM (Upper Extremity Fuegl-Myer) arm motor score and the WMFT (Wolf Motor Function Test), which will track individual trends of motor improvement and motor function, respectively. In four subjects the degree of potentially confounding variables (such as injury and/or patient variability) will likely inhibit extrapolation of therapeutic outcomes to the stroke population at large.
Time frame
Two yearsSponsors and contacts
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University of Washington
Lead sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator
Source ClinicalTrials.gov