First-in-human trial of deep brain stimulation for stroke recovery has begunJanuary 4, 2017 /
Cleveland Clinic has performed the first deep brain stimulation (DBS) surgery for stroke recovery, as part of an ongoing clinical trial assessing the procedure’s potential to improve movement in patients recovering from stroke.
Stroke is the leading cause of long-term disabilities in the United States. Despite rehabilitative efforts, one-third of stroke patients maintain long-term motor deficits severe enough to be disabling.
A team led by Andre Machado, M.D., Ph.D., chairman of Cleveland Clinic’s Neurological Institute, performed the DBS surgery Dec. 19, 2016. During the 6 hour procedure, electrodes were implanted in a part of the patient’s brain called cerebellum, which has extensive connections with the cerebral cortex. Connected to a pace-maker device, DBS electrodes provide small electric pulses as a way to help people recover control of their movements.
“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,” Dr. Machado said. “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.”
Over the next few weeks, the patient – who has been discharged home feeling well and in stable condition – will continue to heal and recover from brain surgery, followed by physical therapy. After a few weeks of rehabilitation, the DBS device will be turned on as the patient continues physical therapy. The patient will be monitored and evaluated regularly to determine how DBS can boost 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., of Cleveland Clinic’s Department of Neurosciences and co-primary investigator on the research grant. “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.”
Dr. Machado’s previous research has shown that DBS targeting the same brain pathway in a laboratory model promotes the brain’s plasticity, the ability to form new neural connections, during recovery from stroke. This clinical trial expands on that work and for the first time translates it to humans. This is currently an experimental approach and, as for any surgical procedure, has risks. Potential risks include hemorrhage, infection and neurological complications. Additional information about the trial can be found at https://clinicaltrials.gov/ct2/show/NCT02835443.
This first-in-human trial is co-funded by an NIH BRAIN Initiative Grant: Brain Research through Advancing Innovative Neurotechnologies and this is among one of many projects exploring human brain activity.
Dr. Machado patented the DBS method in stroke recovery. Boston Scientific owns a license to those patents and provided the Vercise DBS systems used in the trial. In 2010, Cleveland Clinic Innovations established a for-profit spin-off company, Enspire DBS Therapy to fund the clinical trial and commercialize the method; Dr. Machado holds stock options and equity ownership rights with Enspire and serves as the chief scientific officer. Boston Scientific recently invested $2.5 million into Enspire DBS.
Editor’s Note: Photos, videos and an animation are available for download below. An interview with Dr. Macahado and surgery video are available at the following links: