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临床试验/NCT05731648
NCT05731648尚未招募不适用

Role of Functional Neurosurgery in Management of Spasticity

Assiut University0 个研究点目标入组 40 人开始时间: 2023年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
Evaluate safety and efficacy of neurosurgical procedures

研究概览

简要总结

Spasticity can result from a variety of causes in neural axis from which most common are cerebral palsy, strokes, cerebral haemorrhage, multiple sclerosis , traumatic brain injury and spinal cord injury and underlying mechanism is broadly due to decrease inhibition of the spinal network.

Clinical evaluation for spasticity involve series of clinical assessment , physical examination , and neurophysiological testing. quantitative evaluation of spasticity can be measured using modified Ashworth scale which is the most widely used clinical spasticity scale and can be used for various clinical conditions causing spasticity

详细描述

Currently, the management of spasticity spans in a continuum between non-invasive and invasive intervention to modulate its effects and improve patients' Quality of life and when spasticity becomes excessive and aggravates disability, functional neurosurgery can be a resource.

Neurosurgical procedures for management of spasticity are classified according to whether their effect is generalized or focal and whether they are reversible or irreversible. Procedures include intrathecal baclofen pump , spinal cord stimulation and lesioning techniques peripheral nerves , dorsal roots , spinal cord or dorsal root entry zone

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Other

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Patients with spasticity refractory to medical treatment (most commonly administered oral medications for managing spasticity are diazepam, dantrolene sodium, and baclofen) and physiotherapy

排除标准

  • •Patients unfit for neurosurgical intervention

结局指标

主要结局

Evaluate safety and efficacy of neurosurgical procedures

时间窗: 6 month

Rate of complication ( infection , bleeding , Device Malware )

Evaluate Changes in Modified Ashworth scale

时间窗: 6 month

* 0: No increase in muscle tone * 1: Slight increase in muscle tone, with a catch and release or minimal resistance at the end of the range of motion when an affected part(s) is moved in flexion or extension * 1+: Slight increase in muscle tone, manifested as a catch, followed by minimal resistance through the remainder (less than half) of the range of motion * 2: A marked increase in muscle tone throughout most of the range of motion, but affected part(s) are still easily moved * 3: Considerable increase in muscle tone, passive movement difficult * 4: Affected part(s) rigid in flexion or extension

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Zanaty

Assistant lecturer

Assiut University

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