Illustration of a deep brain stimulation lead implanted in the cerebellar dentate nucleus for treatment of post-stroke motor deficits. [Image from Cleveland Clinic]
Dr. Andre Machado and his team performed the 6-hour deep brain stimulation surgery on Dec. 19, 2016. The procedure implanted electrodes into the cerebellum section of the brain. The deep brain stimulation electrodes emit small electric pulses while connected to a pacemaker device and help people recover motor control.
Companies including Boston Scientific, Medtronic, Abbott, Cyberonics, Nevro and EnteroMedics currently have implantable neurostimulators that treat everything from epilepsy and Parkinson’s disease to weight gain and chronic back pain.
There is major demand for better stroke treatments. About 800,000 people experience a stroke yearly, with a new stroke happening every 40 seconds. It is the 5th leading cause of death in the U.S. and 80% of them can be prevented.
“If this research succeeds, it is a new hope for patients that have suffered a stroke and have remained paralyzed after a stroke. It is an opportunity to allow our patients to rehabilitate and gain function and therefore gain independence,” said Machado in a press release. “Our knowledge to date shows that deep brain stimulation can help the brain reorganize, can help the brain adapt, beyond what physical therapy alone can do. The goal of our study is to boost rehabilitation outcomes beyond what physical therapy alone could achieve.”
Post-surgery, patients return home to recover. Upon recovery, they begin physical therapy. The deep brain stimulation is turned on after a few weeks of rehabilitation while the patient continues physical therapy. The patient can be monitored and evaluated regularly to see how deep brain stimulation is boosting the effects of physical therapy.
“In addition to characterizing the effect of treatment on motor recovery, we will examine directly how stimulation affects brain activity using a combination of non-invasive imaging and electrophysiological techniques,” said Kenneth Baker, Ph.D., who is part of Cleveland Clinic’s Department of Neurosciences and one of the primary investigators on this research. “Through these studies, we hope to gain further insight into its therapeutic mechanisms and, perhaps more importantly, how best to optimize delivery of the therapy as we move forward.”
Machado has done previous work in deep brain stimulating by showing that it can target the same brain pathway in laboratory models to promote the brain’s plasticity and the ability to form new neural connections while a patient is recovering from a stroke. The new Cleveland Clinic trial intends to build upon that by using it in humans.
Since this clinical trial is still experimental, there are risks involved. Patients may experience hemorrhage, infection and neurological complications.
This clinical trial is co-funded by a National Institutes of Health BRAIN Initiative Grant: Brain Research through Advancing Innovative Neurotechnologies.
The deep brain stimulation method has been patented by Machado, and Boston Scientific owns licensing to the patents and gave the Cleveland Clinic the Vercise deep brain stimulation system that is used in the trial.
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