Cortical Stimulation for Upper Limb Recovery Following Ischemic Stroke: A Small Phase II Pilot Study of a Fully Implanted Stimulator
By Huang, Mark; Harvey, Richard L.; Stoykov, Mary Ellen; Ruland, Sean; Weinand, Martin; Lowry, David; Levy, Robert; Topics in Stroke Rehabilitation, Vol 15, No. 2, pp. 160-172Publication Date: March-April 2008
Study evaluated the feasibility of a fully-implanted cortical stimulator for improving hand and arm function in patients following ischemic stroke. The investigational device used was a battery-driven pulse generator (IPG) implanted subcutaneously in participants’ chest and connected by a lead to electrodes within an epidural grid placed over the motor cortex of the brain. Following the rehabilitation program, the apparatus was surgically removed. For the study, 24 chronic stroke patients with hemiplegia were randomized to receive either implanted cortical electrical stimulation of the motor cortex combined with upper-limb rehabilitation therapy, or rehabilitation therapy alone. All participants received a total of 65 hours of therapy consisting of use of the affected limb for the manipulation of objects and the completion of self-care tasks. Using repeated-measures regression models, treatment effects between groups were estimated and compared during the 6-month follow-up period. The investigational group had significantly greater mean improvements in Upper Extremity Fugl-Meyer (UEFM) scores as well as Box and Block (B & B) scores when compared to the control group. Save for one report of seizure after device implant, there were no adverse neurologic reactions observed. The study concluded that cortical stimulation with rehabilitation therapy produces a lasting treatment effect in upper-extremity motor control.
Published by: Thomas Land Publishers, Inc. (Website:http://www.thomasland.com)
National Stroke Association (Web Site: http://www.stroke.org )
This publication is included in the library of the National Rehabilitation Information Center (NARIC), accession number J54334
