Cleveland Clinic releases results of a phase 1 trial using Deep Brain Stimulation to help long-term, post-stroke patients regain movement in upper extremities.
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Author: Monica RobinsPublished: 6:31 PM EDT August 14, 2023Updated: 7:36 PM EDT August 14, 2023
CLEVELAND — Cleveland Clinic researchers have found that using Deep Brain Stimulation (DBS) for post-stroke rehabilitation patients is safe and may even help restore movement.
The EDEN trial (Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke) also showed that nine out of 12 patients in the trial had improvement in both motor impairment and function including gains that nearly tripled their initial scores.
Published in Nature Medicine, these findings build on more than a decade of preclinical work led by principal investigators Andre Machado, M.D., Ph.D., and Kenneth Baker, Ph.D., at Cleveland Clinic.
Some of the patients who had improvement had been disabled for up to three years.
Seventy-year-old Stan Shipkosky of Parma took part in the trial. He suffered a stroke six years ago and lost the ability to walk and use his left arm.
Intense physical and occupational therapy helped him regain his ability to walk, but nothing could help his arm. Then he learned about the EDEN trial.
Stan and the other patients underwent DBS surgery, which involved the surgical implantation of electrodes into a part of the brain called the cerebellum. Once connected to a pacemaker-like device, the electrodes were used to deliver small electric pulses to help people recover control of their movements.
After surgery, participants completed months of physical therapy, first with the DBS device turned off for several weeks and then turned on for four-to-eight months. When the device was turned on, researchers noticed the most significant improvements.
“It gave me gradual movement, it wasn’t immediate, it took time, but I had probably a 30 to 40 percent recovery,” Stan said.
“To see the benefit the patient was able to receive was remarkable,” Dr. Baker said.
The device was later removed from the participants.
“What we’re trying to do is promote an environment where the brain can continue, or resume, it’s own recovery process, we just want to enhance that process,” Dr. Baker said.
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The findings encourage the researchers to expand the trial to a second phase that would include more patients. Currently they still plan to only focus on those with upper extremity paralysis, however, there may come a time when they may expand that too if the findings continue to be positive.Stan says even though the results took time, it helped him gain some independence and he hopes others can experience the same.
“I think it’s groundbreaking, I think it’s going to help a lot of people,” Stan said.
Stroke is the leading cause of long-term disabilities. Approximately 800,000 people in the United States alone suffer strokes every year. While the majority of patients will survive the acute phase, persistent neurological issues likely will jeopardize quality of life and productivity, with approximately 50% of survivors still exhibiting disability severities that require assistance with daily activities.
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 Enspire DBS Therapy, Inc., a Cleveland Clinic portfolio company and is commercializing technology developed at Cleveland Clinic to commercialize the method and it co-funded the study. Dr. Machado holds stock options and equity ownership rights with Enspire and serves as the chief scientific officer.
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