The Relationship Between Cyclizing Stimulation and Effective Stimulation During Motor Cortex Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in Pain measured on the Visual Analogue Scale (VAS) with different stimulation settings
研究概览
简要总结
Motor cortex stimulation (MCS) is a form of brain stimulation for patients with neuropathic pain not responsive to medication. An electrode is placed on the surface of the brain and connected to a programmable battery in the chest.
The strength of stimulation can be individually adjusted by changing the voltage of stimulation. A too high voltage will produce side effects (e.g. seizures) while a too low voltage will not provide pain control.
The aim of this study is to analyze the optimal stimulation timing parameters in patients already implanted with MCS and have received good pain relief. The investigators wish to cyclize on/off MCS in order to save the battery life of the stimulator and also decrease stimulus habituation. The investigators hope to determine these timing parameters while maintaining optimal pain relief.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient more than 18 years of age
- •Chronic neuropathic pain effectively treated with motor cortex stimulation
- •Stable medication during the trial
- •Willing and able to comply with the study protocol and to return per the follow-up visit schedule and able to provide informed consent.
排除标准
- •Evidence of an active disruptive psychiatric disorder or other known condition significant enough to impact the perception of pain, compliance to intervention and/or ability to evaluate treatment outcome as determined by the investigator
- •Technical malfunction of the MCS device
- •History of seizures
- •Unable to provide informed consent
研究组 & 干预措施
Original Setting- MCS 30 min off/0 min off
Patients at baseline with their original MCS settings: on 30 minutes, off 0 minutes in any single half-hour.
干预措施: motor cortex stimulation (Change of Stimulation Timing) (Device)
MCS 25 min on/5 min off
Patient MCS settings programmed to: on 25 minutes, off 5 minutes in any single half-hour.
干预措施: motor cortex stimulation (Change of Stimulation Timing) (Device)
MCS 20 min on/10 min off
Patient MCS settings programmed to: on 20 minutes, off 10 minutes in any single half-hour.
干预措施: motor cortex stimulation (Change of Stimulation Timing) (Device)
MCS 15 min on/15 min off
Patient MCS settings programmed to: on 15 minutes, off 15 minutes in any single hour.
干预措施: motor cortex stimulation (Change of Stimulation Timing) (Device)
结局指标
主要结局
Change in Pain measured on the Visual Analogue Scale (VAS) with different stimulation settings
时间窗: At the End of each trial period, typically 14 days after change in stimulation settings
次要结局
- Quality of Life assessment with the SF-36 questionnaire(At the end of each trial period, typically at 14 days after change in stimulation settings)
研究者
Christopher Honey
Associate Professor/Neurosurgeon
University of British Columbia