跳至主要内容
临床试验/NCT06281223
NCT06281223招募中不适用

Study of Brain-spinal Cord Neural Connectivity in Spasticity

Fondation Ophtalmologique Adolphe de Rothschild2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年2月26日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
variation in "spontaneous/resting" cortico-medullo-radiculo-muscular synchronization before and after selective rhizotomy surgery

研究概览

简要总结

Little is known about the peripheral and central mechanisms of action of selective dorsal rhizotomy surgery for the treatment of spasticity. A better understanding of these mechanisms will enable us to improve the surgical procedure. This will require cortico-medullo-radiculo-muscular recordings never before performed and published in the literature, and the identification of variations in connectivity correlated with the clinic.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
3 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Patients aged 3 to 17 years included
  • scheduled for selective rhizotomy surgery
  • Having received informed consent to participate in the study (written consent from both parents)
  • Affiliated or beneficiary of a social security scheme

排除标准

  • Contraindications to selective rhizotomy
  • History of epilepsy
  • Known neurological and/or psychiatric disorders with past and/or current medical treatment, or drug addiction
  • Patient under legal protection
  • Pregnant or breast-feeding women

结局指标

主要结局

variation in "spontaneous/resting" cortico-medullo-radiculo-muscular synchronization before and after selective rhizotomy surgery

时间窗: Day 0

variation in the mean spectral power of the neuronal signal between the brain, spinal cord, roots/radicles and muscles (simultaneous recording levels) before and after surgery. Recordings are expressed as currents, themselves defined by waves. Calculating the average spectral power of the neuronal signal at several points is equivalent to quantifying the power of similarity (frequency and amplitude) between two waves.

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (2)

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