Patients and study design
spasticity, cognitive impairment, contracture, upper-extremity hemiparesis, ischemic stroke
SECONDARY, EVENT, ISCHEMIC STROKE
Eligible individuals suffered a first-time, unilateral, ischemic stroke in the middle cerebral artery territory that spared the diencephalon and basal ganglia 12–36 months before surgery. Individuals with persistent moderate-to-severe upper-extremity hemiparesis as defined by an FM-UE score of ≤42 and sufficient upper-extremity motor ability to engage in rehabilitation (that is, a score of ≥1 on the FM-UE elbow flexion, elbow extension or finger mass flexion or extension) were included. Exclusion criteria included excessive spasticity or contracture of the upper-extremity muscles (that is, Modified Ashworth Scale = 4), severe cognitive impairment (Mini Mental State Examination < 24), as well as surgical, imaging or transcranial magnetic stimulation-related contraindications as detailed in the Candidates were enrolled in an open-label, non-randomized, single-arm trial with a target enrollment of 12 individuals. Participation spanned 20–24 months, with monthly assessments performed to record safety data and secondary metrics (Fig. The study protocol and subsequent amendments were approved by the Food and Drug Administration (investigational device no. G150237; 12/2015) with local approval established by the Institutional Review Board (IRB) of the Cleveland Clinic. Written informed consent was obtained before study-specific testing and re-consent to protocol changes was obtained when applicable. The informed consent process was actively monitored by two neuroethicists (P.F. and L.S.) and an independent Data Monitoring Committee (DMC). The DMC was composed of two neurosurgeons experienced in DBS and one physical medicine and rehabilitation physician. The DMC had the authority to halt the study in case of an unanticipated event or terminate the study in case of a second unanticipated event that did not have an acceptable etiology or resolution.