NeuralCipher Research overview
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Abstract Background and Objectives: Remote programming of deep brain stimulation may improve access to specialized postoperative care for people with Parkinson disease, but prospective randomized evidence remains limited. We aimed to determine whether remote follow-up programming after standardized inpatient initiation is noninferior to conventional in-person follow-up programming for motor outcomes during the early postoperative period. Methods In this prospective, randomized, open-label, multicenter noninferiority trial, adults with idiopathic Parkinson disease who recently underwent bilateral subthalamic nucleus deep brain stimulation implantation at 6 German centers were randomized 1:1 to conventional in-person follow-up programming or remote follow-up programming through a secure telemedicine platform during the first 90 days after surgery. All participants underwent initial in-person postoperative programming before randomization. The primary outcome was the Movement Disorder Society–Unified Parkinson’s Disease Rating Scale Part III score at 90 days in the medication-on and stimulation-on state. The prespecified noninferiority margin was 5 points. Results Fifty-two participants were randomized. The per-protocol population included 26 participants in the conventional care group and 22 in the remote programming group. The between-group median difference of the primary endpoint was − 2.5 points (95% confidence interval − 9.0 to 2.0), meeting the prespecified noninferiority criterion. Secondary clinical outcomes and patient-reported outcomes were broadly comparable between groups. Serious adverse events occurred at similar frequencies in both groups, and no deaths occurred. Conclusions Remote follow-up programming after standardized inpatient initiation was feasible, safe, and clinically effective, achieving motor outcomes noninferior to conventional in-person follow-up care during the first 3 months after surgery. Trial Registration: The trial was prospectively registered at ClinicalTrials.gov (NCT05193825; registered December 21, 2021)
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