Abstract
Functional magnetic resonance imaging and transcranial magnetic stimulation studies suggest that human cortex shows evidence of neuroplasticity. Preclinical studies in rats and monkeys suggest that motor cortical stimulation can enhance plasticity and improve recovery after stroke. This study assesses the safety and preliminary efficacy of targeted subthreshold epidural cortical stimulation delivered concurrently with intensive rehabilitation therapy while using an investigational device in patients with chronic hemiparetic stroke. This is a prospective, multicenter, and nonblinded trial randomizing patients to rehabilitation with or without cortical stimulation. Patients aged 20 to 75 years who had had an ischemic stroke at least 4 months previously causing persistent moderate weakness of the arm were included. Functional magnetic resonance imaging localized hand motor function before surgery to place an epidural cortical electrode. Both groups then underwent rehabilitation for 3 weeks after which the electrode was removed. Outcome measures were obtained at baseline, during therapy, and at 1, 4, 8, and 12 weeks postprocedure. Ten patients were randomized; six patients to surgery, four to the control group. No patient deaths, neurological deterioration, or seizures occurred. There were two infections from nonprotocol-related causes. Of the eight patients completing the treatment, the stimulation plus rehabilitation group improved significantly better than controls in the Upper Extremity Fugl-Meyer (P = 0.003 overall) and the hand function score of the Stroke Impact Scale (P = 0.001 overall). The technique of cortical stimulation to enhance stroke recovery is well tolerated and safe.
Highlights
Title Motor cortex stimulation for the enhancement of recovery from stroke: a prospective, multicenter safety study
There are over 5 million disabled stroke survivors
Patients were randomized into two groups: 1) a treatment group that underwent an electrode (a 3 ϫ 3 grid electrode, Ad-Tech, Racine, WI) implant and subsequent epidural electrical stimulation using an investigational battery powered external pulse generator (Northstar Neuroscience, Seattle, WA) concurrent with 3 weeks of rehabilitation and 2) a group of control stroke patients who received the same 3 weeks of rehabilitation but did not undergo device implantation
Summary
This is a prospective, multicenter, and nonblinded trial randomizing patients to rehabilitation with or without cortical stimulation. Outcome measures were obtained at baseline, during therapy, and at 1, 4, 8, and 12 weeks postprocedure This is a prospective, randomized, multicenter study of the safety of subthreshold motor cortical electrical stimulation of patients with motor deficit resulting from a stroke that occurred at least 4 months before enrollment. Patients were randomized into two groups: 1) a treatment group that underwent an electrode (a 3 ϫ 3 grid electrode, Ad-Tech, Racine, WI) implant and subsequent epidural electrical stimulation (at 50 Hz, 50% of the current needed to evoke gross motor movement) using an investigational battery powered external pulse generator (Northstar Neuroscience, Seattle, WA) concurrent with 3 weeks of rehabilitation (the investigational arm) and 2) a group of control stroke patients who received the same 3 weeks of rehabilitation but did not undergo device implantation. All patients received 16 weeks of assessments, including baseline, during 3 weeks of therapy, and for 12 weeks after the end of rehabilitation therapy
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