NeuralCipher Research overview
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Abstract Background : Subthalamic deep brain stimulation (STN-DBS) effectively treats motor symptoms in Parkinson's disease, but individual responses vary. Despite modern directional leads allowing more precise stimulation, optimal contact selection strategies remain undefined. This study compares a standardized imaging-guided contact selection protocol to conventional clinical programming. Methods : We designed a monocentric, randomized, double-blind crossover trial enrolling 30 people with Parkinson's Disease with bilateral directional STN-DBS. Participants will receive both programming approaches: standardized imaging-guided contact selection targeting the dorsolateral STN and conventional contact selection through clinical test stimulations. Each configuration will be applied for one week. The primary outcome is patient preference after both treatments. Secondary outcomes include motor assessments, accelerometric monitoring and questionnaire-based quality of life measures. Discussion : This study addresses a critical gap in standardization of imaging-guided DBS programming. By using patient preference as the primary outcome, we aim to capture clinically meaningful differences that may not be detected with traditional motor scales. The crossover design balances statistical power with clinical feasibility in specialized care settings. Trial Registration : Deutsches Register für Klinische Studien (DRKS00034229, May 27th, 2024)
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