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Enspire DBS Therapy is developing an implantable neuromodulation device that delivers deep brain stimulation (DBS) to the dentate nucleus in combination with physical rehabilitation for patients with chronic upper extremity impairment following ischemic stroke. The EDEN Phase 1 feasibility study showed that 9 out of 12 participants experienced clinically meaningful improvements in motor function and impairment when treated with DBS plus rehab, especially those with some preserved distal motor function at enrollment. The safety profile was similar to other approved DBS therapies. The pivotal RESTORE Phase 2/3 trial is currently enrolling approximately 40 patients across nine clinical centers to further evaluate long-term safety and efficacy.
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