Dorsal Root Electrical Stimulation to Suppress Spastic Muscle Activation in Children With Cerebral Palsy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Peak-to-peak amplitude of the dorsal root reflex
研究概览
简要总结
The goal of this clinical trial is to evaluate whether dorsal root electrical stimulation could reduce spasticity in children with cerebral palsy (CP).
详细描述
The investigators will recruit participants with CP requiring selective dorsal rhizotomy (SDR) surgery. During SDR, spastic dorsal roots are routinely identified by electrically stimulating each root at low frequency (1 Hz) and measuring the resulting muscle response via electromyography - a procedure called "clinical test stimulation." Dorsal roots that produce an abnormally large and widespread compound muscle action potential (CMAP) are classified as spastic. In this study, the investigators will superimpose higher-frequency dorsal root stimulation (40-5000 Hz) on top of this standard clinical test stimulation and assess whether it suppresses the abnormal large CMAP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children ages 3 to 14
- •Diagnosis of Cerebral Palsy
- •Require an SDR as determined by the multidisciplinary movement disorders team
- •Confirmation that subjects' terms of insurance coverage for their standard of care procedure will not be altered by study enrollment.
排除标准
- •No exclusion criteria
研究组 & 干预措施
Cerebral Palsy Group
The investigators will use the DS8R to directly deliver electrical stimulation with hook electrodes to the dorsal roots while testing the spasticity of individual dorsal roots.
干预措施: Constant Current Stimulator (Device)
Cerebral Palsy Group
The investigators will use the DS8R to directly deliver electrical stimulation with hook electrodes to the dorsal roots while testing the spasticity of individual dorsal roots.
干预措施: Cadwell Guardian System (Device)
结局指标
主要结局
Peak-to-peak amplitude of the dorsal root reflex
时间窗: In session during the surgery (1 session)
The investigators will assess whether dorsal root electrical stimulation at frequencies (40-5000Hz) can normalize the abnormally large muscle response to electrical stimulation of the same dorsal root at low frequencies that is a signature of spasticity in CP. The investigators will measure the peak-to-peak amplitude of the dorsal root reflex with intramuscular EMGs. Succes criteria: A 20% reduction in the peak-to-peak amplitude of the spinal reflex
次要结局
未报告次要终点
研究者
Martin Piazza
Assistant Professor, Pediatric Neurosurgery
University of Pittsburgh