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Deep Brain Stimulation May Help Stroke Patients Recover From Motor Impairment
A first-in-humans trial undertaken by Cleveland Clinic researchers has shown that using deep brain stimulation (DBS) to target the dentate nucleus of the cerebellum may help post-stroke rehabilitation patients recover from motor impairment. Results from the phase I trial were published in Nature Medicine.
“These [findings] are reassuring for patients as the participants in the study had been disabled for more than a year and, in some cases, three years after stroke. This gives us a potential opportunity for much needed improvements in rehabilitation in the chronic phases of stroke recovery,” said Andrew Machado, MD, PhD, chair of Cleveland Clinic’s Neurological Institute. “The quality-of-life implications for study participants who responded to therapy have been significant.”
The open-label, non-randomized phase I EDEN trial (Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke) enrolled 12 individuals with chronic, moderate-to-severe hemiparesis of the upper body, ranging from 1 to 3 years since experiencing unilateral middle cerebral artery stroke. The primary outcomes under investigation were the safety and feasibility of DBS in the chosen patient population. The secondary outcomes were motor impairment and improvement.
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Each participant underwent DBS surgery to implant the electrodes into the cerebellum. After recovering from surgery, the patients completed several months of physical therapy. During the first several weeks of therapy, the DBS device remained turned off. Then, the device was activated for 4 to 8 months.
No serious adverse events, including hemorrhages, infections, deaths, or major perioperative complications emerged throughout the study. The most common adverse effects included pain, nausea, and tingling. Participants also exhibited a median 7-point improvement on the Upper-Extremity Fugl-Meyer Assessment. All individuals who enrolled with partial preservation of distal motor function exhibited clinically significant improvement, regardless of time since stroke, with a median improvement of 15 Upper-Extremity Fugl-Meyer Assessment points.
“Our findings support the safety and feasibility of deep brain stimulation to the cerebellar dentate nucleus as a promising tool for modulation of late-stage neuroplasticity for functional recovery and the need for larger clinical trials,” the authors concluded.
The trial was supported by the National Institute of Health’s BRAIN Initiative as well as by Enspire DBS Therapy, Inc., a Cleveland Clinic portfolio company for which Dr. Machado owns stock options, has equity ownership rights, and served as the chief scientific officer.
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