Stimulation Evoked Primary Afferent Depolarization to Modulate Sensory Transmission to Spinal Motoneurons and the Sensory Cortex
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
- Spinal Circuit Excitability
研究概览
简要总结
The goal of this study is to assess cervical (neck) reflexes by intra-operatively stimulating the neck nerve roots to evoke motor responses through their connections to spinal motoneurons. This data is critical to reveal changes to the spinal sensory modulating circuitry in neurological disorders like stroke.
详细描述
Spinal afferents continuously convey sensory information on limb movements to the central nervous system which not only gives people conscious experience of movement, but also plays a major role in shaping motor output through monosynaptic afferent-motoneuronal connections. Stroke induces changes in the spinal circuitry modulating this sensory input, leading to sensorimotor deficits.
Specifically, the investigators will 1) activate the dorsal root fibers with single and double electrical stimulation pulses at various frequencies using FDA-cleared devices, 2) quantify the stimulation evoked motor potentials in arm and hand muscles recorded with intramuscular EMGs, 3) quantify stimulation evoked sensory potentials in the cortex with intra-op EEGs.
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
- 21 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All Subjects: Ages between 21 and 75 years. The minimum age is selected to age match control subjects with stroke subjects. In addition, participants outside this age range may be at an increased medical risk.
- •Control subjects: Patients undergoing elective posterior cervical spinal surgery that includes a decompressive laminectomy, and who will have electrophysiological monitoring performed as part of the standard of care for their procedure.
- •Stroke subjects: Participants must have a suffered a single, ischemic or hemorrhagic stroke more than 6 months prior to the time of enrollment with hemiparesis as a result, is undergoing a cervical epidural lead implant or undergoing elective posterior cervical spinal surgery that includes a decompressive laminectomy with electrophysiological monitoring performed as part of the standard of care.
排除标准
- •Patients will be excluded from the study if they have any known neurological diseases other than stroke, such as amyotrophic lateral sclerosis, spinal muscular atrophy, spinal cord injury, autoimmune neuropathy, or sensory nerve disorders, that may affect the integrity of cervical sensory afferents.
- •Only patients that are eligible for surgery will be enrolled. Therefore this automatically include as exclusion criteria: pregnancy and other clinical conditions eligible for surgery.
- •Participants must not be on anti-spasticity or anti-epileptic medications.
研究组 & 干预措施
Dorsal Spinal Nerve Root Stimulation
Individuals undergoing cervical spinal surgery will receive direct electrical stimulation to the cervical dorsal spinal nerve roots.
干预措施: Bipolar Neural Stimulation Electrode (Device)
结局指标
主要结局
Spinal Circuit Excitability
时间窗: 1 day
The investigators will record intramuscular electromyogram (EMG) of the hand and arm muscles evoked by dorsal nerve root stimulation at various frequencies to quantify spinal circuit excitability through the H-reflex. A mean difference of 10% from the baseline (first pulse per frequency) muscle activation will be considered a meaningful change in excitability.
次要结局
- Sensory Transmission to the Brain(1 day)
研究者
Peter C. Gerszten, MD
Professor
University of Pittsburgh