Infarction, Middle Cerebral Artery

Study participants showed meaningful improvements in both motor impairment and function CLEVELAND, Aug. 15, 2023 /PRNewswire/ -- Enspire DBS Therapy, Inc., (Enspire) a clinical stage company developing an implantable neuromodulation therapy for post-stroke recovery, announced today the publication of the results of The EDEN trial (Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke), an early feasibility study led by Cleveland Clinic researchers, in Nature Medicine. The EDEN study was designed to evaluate whether DBS plus rehabilitation therapy (DBS+Rehab) would improve motor function in patients post Ischemic Stroke more effectively than rehab alone. The study demonstrated that the majority of participants (9 out of 12) showed the most significant improvements in both motor impairment and function during the combination therapy, DBS+Rehab. Importantly, participants with at least minimal preservation of distal motor function at enrollment showed clinically significant gains. The safety pro this therapy is similar to other approved DBS therapies. 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. Dr. Machado patented the DBS method in stroke recovery to which Enspire has an exclusive license. Dr. Machado holds stock options and equity ownership rights with Enspire and serves as the Chief Scientific Officer. "We saw patients in the study regain levels of function and independence they did not have before enrolling in the research," Dr. Machado said. "We look forward to expanding as we have begun the next phase of clinical investigation." Enspire has launched RESTORE, a pivotal study continuing to investigate the safety and effectiveness of DBS+Rehab on patients with chronic upper extremity impairment due to stroke. The study has received IDE approval from the FDA and is actively recruiting patients. About Stroke Approximately 800,000 people in the United States alone suffer strokes every year and is the leading cause of long-term disabilities. While the majority of patients will survive the acute phase, persistent neurological issues will likely jeopardize quality of life and productivity, with approximately 50% of survivors still exhibiting disability severities that require assistance with daily activities. About EDEN The EDEN trial (Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke) conducted at Cleveland Clinic, enrolled 12 individuals with chronic, moderate-to-severe hemiparesis of the upper extremity as a result of a unilateral middle cerebral artery stroke 1-3 years prior. Each participant was implanted with a DBS System, which involved the surgical implantation of electrodes into the cerebellum. Following discharge and recovery from the surgery, participants completed several months of physical therapy, first with the DBS device turned off for several weeks and then turned on for four-to-eight months. About RESTORE The RESTORE Stroke Pivotal Study will evaluate the safety and effectiveness of DBS+Rehab for treating arm weakness and reduced function after a stroke to support marketing approval of this therapy. Each participant will be implanted with a commercially available third-party DBS system and receive a five-month outpatient rehabilitation therapy program. After five months of blinded randomized testing, participants assigned to active-control treatment (Ct) (rehab only) will cross over to receive DBS treatment (Tt) and participate in a second five-month therapy program. For more information see ClinicalTrials.gov ID NCT05701280. The RESTORE trial is actively recruiting. DBS for stroke is investigational use; clinical studies for this indication are conducted under Enspire's approved IDE from FDA. About Enspire Enspire DBS Therapy, Inc. headquartered in Cleveland, OH, is a clinical stage medical device company focused on providing neuromodulation solutions to patients suffering with disabilities from stroke. Established in 2010, Enspire is a Cleveland Clinic portfolio company with the goal of commercializing novel technology. For more information, visit

A first-in-human trial of deep brain stimulation (DBS) for post-stroke rehabilitation patients has shown that using DBS to target the dentate nucleus -- which regulates fine-control of voluntary movements, cognition, language, and sensory functions in the brain -- is safe and feasible. A first-in-human trial of deep brain stimulation (DBS) for post-stroke rehabilitation patients by Cleveland Clinic researchers has shown that using DBS to target the dentate nucleus -- which regulates fine-control of voluntary movements, cognition, language, and sensory functions in the brain -- is safe and feasible. The EDEN trial (Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke) also shows that the majority of participants (nine out of 12) demonstrated improvements in both motor impairment and function. Importantly, the study found that participants with at least minimal preservation of distal motor function at enrollment showed gains that almost 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. "These 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 Dr. Machado, chair of Cleveland Clinic's Neurological Institute. "The quality-of-life implications for study participants who responded to therapy have been significant." 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. "We saw patients in the study regain levels of function and independence they did not have before enrolling in the research," Dr. Machado said. "This was a smaller study and we look forward to expanding as we have begun the next phase." The completed EDEN trial enrolled 12 individuals with chronic, moderate-to-severe hemiparesis of the upper extremity as a result of a unilateral middle cerebral artery stroke 12-to-36 months prior. There were no major complications throughout the study. Nine of the 12 participants improved to a degree that is considered meaningful in stroke rehabilitation. Each participant underwent DBS surgery, which involved the surgical implantation of electrodes into a part of the brain called the cerebellum. Once connected to a pace-maker-like device, the electrodes were used to deliver small electric pulses to help people recover control of their movements. Following discharge and recovery from the 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. It was after turning the device on that the most significant improvements were observed. "The safety and feasibility data from this early study combined with the potential symptom improvements certainly support the need for additional, larger trials to see if cerebellar DBS is indeed a potential treatment for post-stroke motor impairment," said Brooks Gross, Ph.D., program director, National Institute of Neurological Disorders and Stroke. 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. "There are currently no effective methods to improve the outcomes of physical rehabilitation for the hundreds of thousands of stroke survivors," said Dr. Baker, Cleveland Clinic Lerner Research Institute. "The results of the study found that deep brain stimulation, paired with physical therapy, improved movement in patients who were more than a year out from their stroke and whose motor improvements had largely plateaued. This tells us the research warrants further investigation in larger patient samples." Research reported in this press release was supported by the NIH Brain Research Through Advancing Innovative Neurotechnologies® Initiative, or The BRAIN Initiative®, under award number UH3NS100543. The study was also supported by Enspire DBS Therapy, Inc.

Financing round led by Cleveland Clinic with participating investors JobsOhio Growth Capital Fund and an undisclosed investor Proceeds will enable the initiation of the pivotal clinical trial RESTORE CLEVELAND, Aug. 1, 2023 /PRNewswire/ -- Enspire DBS Therapy, Inc., (Enspire) a clinical stage company developing an implantable neuromodulation therapy for post-stroke recovery, announced today that it raised $17.6 million of committed capital in a Series B financing led by existing investor, Cleveland Clinic. Also participating in the round were JobsOhio Growth Capital Fund and an undisclosed investor. The company plans to use the proceeds to initiate the RESTORE pivotal clinical trial using deep brain stimulation (DBS) and rehab therapy (DBS + Rehab) to treat patients with chronic upper extremity impairment due to stroke. "The first trial in humans known as EDEN (Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke), was a proof-of-concept study combining DBS with Rehab to help stroke patients regain function. The results from EDEN led to this Series B raise," said Scott Kokones, Chief Executive Officer of Enspire, "With RESTORE, the company aims to generate the data necessary to demonstrate the long-term safety and efficacy of DBS+Rehab in Stroke patients to support marketing approval." "Cleveland Clinic Innovations is dedicated to supporting technologies to enhance patient outcomes. Our most recent investment in Enspire DBS aligns with our focus on innovative neuro-stimulation solutions addressing significant clinical challenges," said JD Friedland, Managing Director of Ventures at Cleveland Clinic Innovations. "Enspire's emphasis on operationalizing and advancing new technology matches the mission of Cleveland Clinic Innovations." About Stroke Approximately 800,000 people in the United States suffer strokes yearly, which is the leading cause of long-term disabilities. While most patients will survive the acute phase, persistent neurological issues will likely jeopardize the quality of life and productivity, with approximately 50% of survivors still exhibiting disability severities that require assistance with daily activities. About EDEN The EDEN trial (Electrical Stimulation of the Dentate Nucleus for Upper Extremity Hemiparesis Due to Ischemic Stroke) conducted at The Cleveland Clinic enrolled 12 individuals with chronic, moderate-to-severe hemiparesis of the upper extremity because of a unilateral middle cerebral artery stroke 1-3 years prior. Each participant was implanted with a DBS System, which involved the surgical implantation of electrodes into the cerebellum. Following discharge and recovery from the surgery, participants completed several months of physical therapy, first with the DBS device turned off for several weeks and then turned on for four-to-eight months. DBS for stroke is investigational use; clinical studies for this indication are conducted under Enspire's approved IDE from FDA. About RESTORE The RESTORE Stroke Pivotal Study will evaluate the safety and effectiveness of DBS + Rehab for treating arm weakness and reduced function after a stroke to support marketing approval of this therapy. Each participant will be implanted with a commercially available third-party DBS system and receive a five-month outpatient rehabilitation therapy program. After five months of blinded randomized testing, participants assigned to active-control treatment (Ct) (rehab only) will cross over to receive DBS treatment (Tt) and participate in a second five-month therapy program. For more information, see ClinicalTrials.gov ID NCT05701280. The RESTORE trial is actively recruiting. About Enspire Enspire DBS Therapy, Inc., headquartered in Cleveland, OH, is a clinical-stage medical device company focused on providing neuromodulation solutions to patients suffering from disabilities from stroke. Established in 2010, Enspire is a Cleveland Clinic portfolio company with the goal of commercializing novel therapies. For more information, visit