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临床试验/NCT05984329
NCT05984329已完成不适用

Tonic Versus Burst DR(TM) Epidural Motor Cortex Stimulation for Neuropathic Pain : a Double-blind, Crossover, Comparative Study

Centre Hospitalier Universitaire de Saint Etienne1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2022年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
14
试验地点
1
主要终点
Percentage of pain relief

研究概览

简要总结

Epidural stimulation of the primary motor cortex (PMC) is indicated for the relief of neuropathic pain refractory to pharmacological treatment.

详细描述

The main objective of this study is to compare the analgesic effect of two distinct waveforms (i.e. tonic versus Burst DR(TM)) delivered by an epidural stimulator of the (primary) motor cortex in patients suffering from neuropathic pain resistant to the best pharmacological treatment.

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients suffering from neuropathic pain refractory to best pharmacological treatment, operated on for MCS with an internal pulse generator (IPG) capable of delivering both tonic and Burst DR(TM) stimulation waveforms.

排除标准

  • Patients under 18 years old ; pregnancy

结局指标

主要结局

Percentage of pain relief

时间窗: 6 months

Percentage of analgesic relief compared with baseline (i.e. preoperative pain level)

次要结局

  • Antalgic drugs intake(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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