闭环DBS系统

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最新临床结果!美敦力全球首个闭环DBS系统
思宇MedTech· 2025-09-24 09:09
Core Viewpoint - Medtronic's ADAPT-PD trial results demonstrate the safety and efficacy of the BrainSense™ adaptive deep brain stimulation (aDBS) system for treating Parkinson's Disease, marking a significant advancement in personalized neurostimulation therapy [1][22]. Clinical Trial Results (ADAPT-PD) - The ADAPT-PD study is a multi-center, prospective, single-blind, randomized crossover trial initiated in 2021, involving 68 primary cohort patients and 17 directional stimulation cohort patients across 10 research centers in the US, Canada, and Europe [2]. - Two adaptive algorithm modes were tested: Single Threshold mode, which adjusts stimulation intensity rapidly within 250 milliseconds, and Dual Threshold mode, which changes stimulation intensity gradually over several minutes [4]. Key Results - Under the Dual Threshold aDBS mode, patients experienced an average increase of approximately 1.3 hours in daily ON time and a reduction of about 1.6 hours in OFF time; when using a self-selected aDBS mode, ON time increased by about 1.4 hours and OFF time decreased by 1.7 hours [7]. - The primary endpoint showed that 91% of patients in the Dual Threshold mode achieved equivalence in "ON time without troublesome dyskinesia" compared to traditional continuous DBS, while the Single Threshold mode had a success rate of 79% [10]. Product Technical Features (BrainSense™ aDBS System) - The BrainSense™ aDBS system features a closed-loop design that allows real-time monitoring of brain activity and automatic adjustment of stimulation parameters, enhancing treatment personalization and reducing the need for frequent manual adjustments [15]. - Energy efficiency was noted, with the Single Threshold aDBS mode showing an average reduction of about 15% in total energy consumption compared to continuous DBS, indicating potential for extended battery life [16]. Clinical Evidence - The clinical validation of the BrainSense™ aDBS system has progressed through a series of studies, culminating in the publication of the ADAPT-PD trial results in JAMA Neurology, confirming the efficacy and safety of the aDBS technology [22][23]. Impact on Parkinson's Disease Treatment - The introduction of the BrainSense™ aDBS system addresses the limitations of traditional DBS, which often requires frequent adjustments due to its continuous stimulation approach, thereby improving patient quality of life [24][26]. - The results from the ADAPT-PD trial signify a transformative shift in treatment modalities from continuous stimulation to intelligent, personalized, and dynamic interventions, potentially setting a new standard for precision neurotherapy [26].