The Efficacy of Motor Cortex Stimulation for Pain Control
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Visual Analog scale
研究概览
简要总结
The objective is to determine if motor cortex stimulation works for the following conditions:
- Deafferentation facial pain,
- Upper extremity complex regional pain syndrome (CRPS) and
- Brachial plexus avulsion or phantom limb pain.
Each of these groups of 6 patients (total of 18) will be studied independently and all patients will be implanted with a motor cortex stimulation system. They will be randomised to either a regular or low stimulation setting in the two arms of the study. Each arm will last 3 months.
详细描述
This is a prospective, blinded randomized crossover study comparing two stimulation paradigms in three different groups of patients receiving motor cortex stimulation. The aim of this study is to examine the effectiveness of this modality in a controlled blinded manner, which has not been done in previous studies. There are two primary purposes of this study. The first is to compare two different stimulation paradigms: "high" level stimulation (i.e. stimulator activated 'on' for 10 minutes, 'off' for 2 hours; presumed therapeutic dose); versus "low" stimulation ('on' for 1 minute, 'off' for 6 hours; presumed subtherapeutic dose), in a prospective blinded crossover study design.
The second purpose of this study, is to examine the outcome of MCS in three different pain groups. These are:
- Unilateral upper extremity neuropathic pain such as brachial plexus avulsion, stump pain or phantom limb pain
- Neuropathic deafferentation facial pain
- Upper extremity complex regional pain syndrome (CRPS)
Measurements of the effects of motor cortex stimulation will include a visual analogue scale (VAS) of perceived pain, the McGill Pain Questionnaire, SF-36 quality of life questionnaire, Beck Depression Inventory-II, the standard 7-point patient global impression of change (PGIC), medications log (verified by pharmacy records) and an employment status questionnaire. Adverse events will be recorded at each visit.
Table 1:
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 (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis in one of the following three categories:
- •Unilateral upper extremity neuropathic pain such as phantom limb pain, stump pain or brachial plexus avulsion
- •Neuropathic deafferentation facial pain
- •Upper extremity complex regional pain syndrome (CRPS)
- •Pain is refractory to conservative methods (e.g. medications, regional blocks) as reviewed by a chronic pain clinical physician
- •Patient is considered a good candidate for neurosurgery, i.e. no other medical problems that would preclude surgery
- •Patients who are willing to provide informed consent.
排除标准
- •Patients who are not considered medically fit for neurosurgery.
- •Patients who have not exhausted conservative methods of pain control, prior to considering motor cortex stimulation.
- •Patients who are not able to provide informed consent.
- •Patients unable to have magnetic resonance imaging (MRI).
结局指标
主要结局
Visual Analog scale
时间窗: 1 month preop, at 12 and 24 weeks postop
Beck II depression
时间窗: 1 month preop, at 12 and 24 weeks postop
McGill Pain questionnaire
时间窗: 1 month preop, at 12 and 24 weeks postop
Employment status
时间窗: 1 month preop, at 12 and 24 weeks postop
SF-36
时间窗: 1 month preop, at 12 and 24 weeks postop
Medications log
时间窗: 1 month preop, at 12 and 24 weeks postop
Global impression of change
时间窗: at 12 and 24 weeks postop
次要结局
未报告次要终点