Paired Associative Stimulation in Subacute Spinal Cord Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Daniels and Worthingham's Muscle Testing
研究概览
简要总结
The investigators have recently 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 at the subacute stage, and investigate its effectiveness for upper extremity rehabilitation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •SCI caused by an external trauma or SCI caused by nontraumatic non-progressive disease of the spinal cord
- •Cervical level injury, tetraplegia
- •Time from injury/onset of symptoms 1-4 months
- •Medical condition stable
- •Residual neural connectivity in upper extremity: some voluntary activity in finger muscles or MEPs obtainable from distal hand muscles
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
- •Implanted hearing device
- •Progressive diseases of spinal cord or brain (e.g. malignant tumors, degenerative diseases).
- •History of malignant tumor within the past 5 years.
- •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.
- •Severe emergency care polyneuropathy
- •Pressure ulcer affecting the subject's capability to undergo the procedure safely
研究组 & 干预措施
Sham
干预措施: Sham paired associative stimulation (Device)
Paired Associative Stimulation
干预措施: Paired associative stimulation (Device)
结局指标
主要结局
Daniels and Worthingham's Muscle Testing
时间窗: Change from baseline score immediately after, 6 months after and 1 year after last stimulation session
hand muscle strength is evaluated on 0-5 scale (0=no movement, 5=normal)
Spinal Cord Independence Measure (SCIM)
时间窗: Change from baseline score immediately after, 6 months after and 1 year after last stimulation session
standard SCIM evaluation
次要结局
未报告次要终点
研究者
Anastasia Shulga
Principle Investigator
Helsinki University Central Hospital