NCT03886857已完成不适用
Carry-over Effects of Transcutaneous Spinal Cord Stimulation for Spasticity Control on Inhibitory Circuits of the Spinal Cord: a Pilot Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Postsynaptic inhibition
研究概览
简要总结
The aim of the pilot study is to gain first insights into the interaction of transcutaneous spinal cord stimulation with the altered activity of intraspinal circuits associated with spinal spasticity. The main goal is to evaluate the validity of the chosen measures and to generate a data base for statistical planning of a subsequent clinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •written informed consent prior to participation
- •for participants with intact CNS:
- •no previous neurological or musculoskeletal disorders
- •for participants with spinal cord injury:
- •Spinal cord injury due to trauma
- •≥ 12 months post-spinal cord injury
- •complete or incomplete spinal cord injury classified as grade C or D on the American Spinal Injury Association Impairment Scale (AIS)
- •neurological level of spinal cord injury: C3-T10
- •preserved tendon and cutaneo-muscular reflexes in the lower limbs
排除标准
- •other neuromuscular diseases, e.g., amyotrophic lateral sclerosis (ALS), Parkinson's disease, Guillain-Barré syndrome, muscular dystrophy
- •active implants (e.g., cardiac pacemaker, drug pump)
- •passive implants at vertebral level T10 or caudal (e.g., metal screws/plates for surgical stabilization of spinal fractures)
- •active infections or diseases, pressure sores
- •dermatological issues at the stimulation site
- •malignant diseases
- •heart insufficiency (NYHA III-IV)
- •potential pregnancy (pregnancy test to be conducted in women of child bearing age before application of transcutaneous spinal cord stimulation)
结局指标
主要结局
Postsynaptic inhibition
时间窗: pre-intervention to 2 hours post-intervention
reciprocal inhibition of the soleus H-reflex
次要结局
- Presynaptic inhibition(pre-intervention to 2 hours post-intervention)
- H_max/M_max(pre-intervention to 2 hours post-intervention)
- Low-frequency depression(pre-intervention to 2 hours post-intervention)
- Evaluation of lower-limb spasticity(pre-intervention to 2 hours post-intervention)
研究者
Peter Lackner
Chief Physician
Klinikum Floridsdorf
研究点 (4)
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