NCT00122915终止3 期
A Prospective, Randomized, Double Blind, Crossover, Multi-center Study to Evaluate the Safety and the Efficacy of Motor Cortex Stimulation With the Cortical Stimulation Lead Model 2976 in Patients With Neuropathic Pain
适应症
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 104
- 试验地点
- 11
- 主要终点
- Adverse events reports
研究概览
简要总结
The CONCEPT study has been designed to evaluate the safety and the efficacy of Motor Cortex Stimulation (MCS) with a new cortical lead (circular lead, eight electrodes, Medtronic Inc, Minneapolis, USA) in the treatment of intractable neuropathic pain, in particular for central post-stroke pain (CPSP) and trigeminal neuropathic pain (TGN)/facial pain.
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
- Double
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
- •CPSP or TGN/facial pain refractory to other medical treatments
- •Pain > 1 year prior to baseline
- •Pain intensity with an average daily VAS score > 5 demonstrated by 12 ratings across 4 days
- •Stable pain medication for > 1 month prior to baseline
排除标准
- •CPSP with important paresis/severe motor deficit in the area of pain
- •TGN/facial pain with complete deafferentation pain
- •Atypical facial pain, i.e. when objective evidence for neuropathic facial pain syndromes is lacking and when specific psychological and behavioral factors can be identified
- •Pain associated with malignant neoplastic disease anywhere in the body or head
- •History of epilepsy
- •Presence of a deterioration of cognitive functions
结局指标
主要结局
Adverse events reports
Pain assessed by Visual Analogue Scale (VAS)
次要结局
- Analgesic, sedative or psychoactive medication intake
- Quality of life
- Disability
研究者
研究点 (11)
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