Cortical stimulation for upper limb recovery following ischemic stroke: a small phase II pilot study of a fully implanted stimulator.
OBJECTIVE
To evaluate the feasibility of a fully implanted cortical stimulator for improving hand and arm function in patients following ischemic stroke.


METHODS
Twenty-four chronic stroke patients with hemiplegia were randomized to targeted implanted cortical electrical stimulation of the motor cortex with upper limb rehabilitation therapy or rehabilitation therapy alone.


RESULTS
Using repeated measures regression models, we estimated and compared treatment effects between groups over the study follow-up period. The investigational group had significantly greater mean improvements in Upper Extremity Fugl-Meyer (UEFM) scores during the 6-month follow-up period (weeks 1-24 following therapy), as compared to the control group (difference in estimated means = 3.8, p = .042). Box and Block (B & B) test improvement from baseline scores were also significantly better in the investigational group across the 6-month follow-up assessments (difference in estimated means = 3.8, p = .046). There was one report of seizure after device implant but prior to cortical stimulation and rehabilitation therapy, but no reports of neurologic decline. There were no improvements seen in the other measures assessed.


CONCLUSIONS
Evidence suggests that cortical stimulation with rehabilitation therapy produces a lasting treatment effect in upper extremity motor control and is not associated with serious neurological complications. A larger multicenter study is underway.
Huang
Mark
M
Department of Physical Medicine and Rehabilitation, The Feinberg School of Medicine, Northwestern University, Rehabilitation Institute of Chicago, Chicago, Illinois, USA.
Harvey
Richard L
RL
Stoykov
Mary Ellen
ME
Ruland
Sean
S
Weinand
Martin
M
Lowry
David
D
Levy
Robert
R
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002545:Brain Ischemia / Q000503:physiopathology / Q000534:rehabilitation*; D004599:Electric Stimulation Therapy / Q000009:adverse effects / Q000379:methods; D005260:Female; D006429:Hemiplegia / Q000209:etiology / Q000503:physiopathology / Q000534:rehabilitation; D006801:Humans; D008297:Male; D008875:Middle Aged; D009044:Motor Cortex / Q000502:physiology*; D026741:Physical Therapy Modalities; D010865:Pilot Projects; D011446:Prospective Studies; D019736:Prostheses and Implants; D020127:Recovery of Function / Q000502:physiology; D012640:Seizures / Q000209:etiology; D020521:Stroke / Q000150:complications; D000071939:Stroke Rehabilitation; D016896:Treatment Outcome; D034941:Upper Extremity