Paired Associative Stimulation for Post- Spinal Cord Injury Neuropathic Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Numeric Rating Scale
研究概览
简要总结
The investigators have shown in incomplete SCI patients that long-term paired associative stimulation is capable of restoring voluntary control over some paralyzed muscles and enhancing motor output in the weak muscles. In this study, the investigators will administer long-term paired associative stimulation to patients with incomplete cervical level SCI and SCI- associated neuropathic pain, and investigate its effectiveness for neuropathic pain treatment.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •incomplete cervical spinal cord injury
- •time from injury at least 1.5 years
- •chronic SCI- induced neuropathic pain in the upper limb
排除标准
- •Diagnosed brain damage, visible in MRI or CT.
- •No activity in hands/fingers and no MEPs recorded from distal hand muscles.
- •Metal inclusion in the head area
- •High intracranial pressure
- •Pacemaker
- •Implanted hearing device
- •Progressive diseases of spinal cord or brain (e.g. malignant tumors, degenerative diseases).
- •Previous head or spinal cord injury affecting the motor performance of upper extremities.
- •Congenital anomaly in the anatomical structure of spinal canal/cord or dura.
- •Significant systemic disease or other condition that could cause neurological deficit, or may affect subject's capability to undergo investigation-related procedures.
- •Acute severe infection.
- •Contraindications for MRI.
- •Current severe psychiatric diseases.
- •Current chronic drug and/or alcohol abuse.
- •Pregnancy.
- •Pressure ulcer affecting the subject's capability to undergo the procedure safely
结局指标
主要结局
Numeric Rating Scale
时间窗: Change from baseline at 8 weeks after the intervention
0-10 scale, 0 - no pain, 10 - worst possible pain.
Brief Pain Inventory
时间窗: Change from baseline at 8 weeks after the intervention
0-10 scale, 0 - no pain, 10 - worst possible pain.
次要结局
未报告次要终点
研究者
Anastasia Shulga
Head of Department
Helsinki University Central Hospital