NCT00860210已完成1 期
Pilot Feasibility Study of the Neurostep™ System in Subjects With Gait Disorder Secondary to CNS Lesion.
Neurostream Technologies G.P.8 个研究点 分布在 3 个国家目标入组 14 人开始时间: 2007年10月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 8
- 主要终点
- Electrophysiological integrity of the nerves surrounded by the nerve cuffs assessed using Nerve Conduction Velocity (NCV) tests. Status Quo in physical examinations of the subject.
研究概览
简要总结
This pilot feasibility study is assessing the safety and technical performance of the Neurostep™ System for the restoration of independent gait in subjects with gait disorder (i.e. foot drop) secondary to a CNS lesion (e.g. stroke).
详细描述
The Neurostep™ System is a neurostimulation investigational medical device. The entire system is designed to be implanted into the subject's leg via a surgical procedure, during which electrodes are attached to the peripheral nerves responsible for sensing and stimulating the proper muscles that lift the foot during normal walking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with a unilateral gait disorder as a result of a specified CNS lesion (e.g., stroke)with stable neurological deficit for at least 6 months
- •Medically stable, able to and agree to undergo a surgery
- •Able to stand and walk at least 5 meters
- •Agree to attend frequent study scheduled visits
- •Able to provide verbal or written feedback
- •Have provided written informed consent
- •Have intact tibial and common peroneal nerves
排除标准
- •Pregnant or nursing women
- •Medically insufficiently stable to undergo surgery
- •Poor range of motion of affected ankle or fixed ankle
- •Foreseen need for Magnetic Resonance Imaging (MRI)
- •Significant mental or psychiatric impairment
- •Cannot understand or provide signed informed consent
- •Cannot provide verbal or written feedback
- •Have been implanted with a pacemaker or other active medical device
- •Must continuously take anticoagulants
- •Uncontrolled heart or cardiovascular-related disease conditions
- •Have been diagnosed with muscle atrophy and/or peripheral polyneuropathy
结局指标
主要结局
Electrophysiological integrity of the nerves surrounded by the nerve cuffs assessed using Nerve Conduction Velocity (NCV) tests. Status Quo in physical examinations of the subject.
时间窗: Throughout the study period (23 weeks)
次要结局
- Ability to stimulate the common peroneal nerve and selectively activate ankle dorsiflexor muscles to produce symmetrical motion of the foot. Ability to sense the heel-strike and toe-lift events during walking.(From the surgical implantation to the end of the study (i.e. 20 weeks))
研究者
研究点 (8)
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