Enspire DBS Therapy has announced the publication of the results of the EDEN trial—an early feasibility study led by Cleveland Clinic (Cleveland, USA) researchers assessing electrical stimulation of the dentate nucleus for upper-extremity hemiparesis due to ischaemic stroke—in Nature Medicine.
The EDEN study was designed to evaluate whether deep brain stimulation (DBS) plus rehabilitation therapy (DBS plus rehab) would improve motor function in post-ischaemic stroke patients more effectively than rehab alone.
The study demonstrated that the majority of participants (9/12) showed the most significant improvements in both motor impairment and function during the combination therapy, DBS plus rehab. Importantly, an Enspire press release notes, participants with at least minimal preservation of distal motor function at enrolment showed clinically significant gains. The safety profile of this therapy is similar to other approved DBS therapies, the release adds.
These findings build on more than a decade of preclinical work led by principal investigators Andre Machado and Kenneth Baker (both Cleveland Clinic, Cleveland, USA). Machado patented the DBS method in stroke recovery to which Enspire has an exclusive license. He also holds stock options and equity ownership rights with Enspire, and serves as the company’s chief scientific officer.
“We saw patients in the study regain levels of function and independence they did not have before enrolling in the research,” Machado said. “We look forward to expanding as we have begun the next phase of clinical investigation.”
Enspire has also launched RESTORE, a pivotal study continuing to investigate the safety and effectiveness of DBS plus rehab in patients with chronic upper-extremity impairment due to stroke. The study has received investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) and is actively recruiting patients.
