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美敦力推出研究帕金森病适应性深部脑刺激的新方法

Medtronic unveils novel approach to studying adaptive deep brain stim for Parkinson’s

MASSDEVICE 等信源发布 2024-09-17 03:37

可切换为仅中文


Medtronic’s Percept PC neurostimulator with BrainSense technology [Image courtesy of Medtronic]Medtronic

美敦力采用BrainSense技术的Percept PC神经刺激器[图片由美敦力提供]美敦力

(NYSE: MDT)

(纽约证券交易所:MDT)

today announced the publication of its novel approach to studying adaptive deep brain stimulation (aDBS).

今天宣布发表了研究适应性深部脑刺激(aDBS)的新方法。

The approach was studied in the Nature Portfolio of journals’ npj Parkinson’s Disease. It outlines the medtech giant’s adaptive DBS algorithm for personalized therapy in Parkinson’s disease (ADAPT-PD). The global, multi-center, prospective, single-blind, randomized crossover study looks at the safety and effectiveness of chronic dual and single threshold aDBS models as compared to continuous DBS across all Parkinson’s patients eligible for DBS..

该方法在《npj帕金森氏病》期刊的自然组合中进行了研究。它概述了medtech巨人用于帕金森病个性化治疗的自适应DBS算法(ADAPT-PD)。这项全球,多中心,前瞻性,单盲,随机交叉研究着眼于慢性双阈值和单阈值ADB模型与所有符合DBS条件的帕金森病患者的连续DBS相比的安全性和有效性。。

Medtronic said the study remains ongoing as the largest, longest assessment of aDBS in an at-home setting. To date, the company reports 68 participants with either subthalamic nucleus or globus pallidus internus DBS connected to a Percept PC neurostimulator.

美敦力表示,这项研究仍在进行中,是在家中对ADB进行的最大、最长的评估。迄今为止,该公司报告了68名参与者,他们的丘脑底核或苍白球内DBS连接到Percept PC神经刺激器。

Investigators monitored participants over four phases spanning more than a year. That included baseline examination, initial aDBS setup and adjustment, evaluation and long-term follow-up. Medtronic then offered all participants extended access to aDBS therapy after the follow-up period.

调查人员对参与者进行了为期一年多的四个阶段的监测。这包括基线检查,初始ADB设置和调整,评估和长期随访。随后,美敦力为所有参与者提供了在随访期后延长ADB治疗的机会。

Preliminary data indicates a high brain signal presence both on and off medications, in both DBS target locations and patients of all PD phenotypes.

初步数据表明,在DBS目标位置和所有PD表型的患者中,药物治疗和非药物治疗均存在高脑信号。

Medtronic recently filed for FDA approval of aDBS. It expects the results of its ADAPT-PD trial to support global regulatory submissions.

美敦力(Medtronic)最近申请FDA批准ADB。它预计ADAPT-PD试验的结果将支持全球监管提交。

“For more than three decades, Medtronic’s investment in DBS research has led to significant improvements in therapeutic treatment for movement disorders and epilepsy,” said Amaza Reitmeier, VP and GM, Medtronic Brain Modulation. “This first-of-its-kind trial is a significant step forward in our journey to bring sensing-enabled DBS enhancements to patients.”The Medtronic Percept family of neurostimulators with exclusive BrainSense technology is the first and only DBS system with sensing, directionality, and advanced programming..

Medtronic Brain Modulation副总裁兼总经理Amaza Reitmeier表示:“三十多年来,美敦力对DBS研究的投资使运动障碍和癫痫的治疗取得了重大改进。”。“这是首次此类试验,这是我们为患者带来感知功能DBS增强的旅程中迈出的重要一步。”美敦力Percept神经刺激器家族采用独家BrainSense技术,是第一个也是唯一一个具有感知、方向性和高级编程功能的DBS系统。。