One Step Closer to First Human Use of DBS for Stroke Recovery
Cleveland Clinic announces it’s ready to start enrollment in a pioneering trial of deep brain stimulation following official clearance from the FDA.
Cleveland Clinic is ready to begin the first human trial of deep brain stimulation (DBS) for post-stroke physical rehabilitation. So announced the trial’s leader, Andre Machado, MD, PhD, Chairman of Cleveland Clinic’s Neurological Institute, this week. The news follows Cleveland Clinic’s recent approval from the FDA to conduct the pioneering trial, as reported earlier this year on Consult QD.
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The go-ahead from the FDA came after 10 years of research by Dr. Machado and his team using a rodent model of stroke. That work showed that stimulation of a novel brain pathway promoted motor recovery along with neurogenesis and angiogenesis in the thalamus and perilesional cortex, as reported last year.
“Our findings suggested that DBS of the cerebello-thalamo-cortical pathway may enhance the brain’s plasticity and ability to form new neural connections during recovery from stroke,” says Dr. Machado, a neurosurgeon (shown in surgery in the photo above) who will perform the DBS procedures in the newly launched trial. “The expectation is that stimulation may augment the effects of physical rehabilitation for stroke.”
He notes that the cerebellum, which controls voluntary muscle movements, was part of the region targeted for stimulation in the hope of reestablishing flow of neurological input to the brain hemisphere affected by stroke.
Candidates for the new trial will be ischemic stroke patients who suffered a stroke 12 to 24 months previously and have residual severe weakness affecting one arm despite treatment with physical therapy. Key questions the trial will seek to address include:
Dr. Machado notes that the goal of DBS in this setting is to augment, not replace, the effects of physical rehabilitation. “The proposition here is to make that recovery greater,” he told Time magazine in a new exclusive interview.
In the same interview he noted what most distinguishes this latest application of DBS from prior uses of the technology, such as for movement disorders: “The big difference is that when we are treating the motor symptoms of Parkinson’s disease, we’re trying to make the symptom, like a tremor, go away. When we are treating stroke, we are really trying to make movement come back. There is something inherently different about that.”