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临床试验/NCT03347240
NCT03347240已完成不适用

Comparative Study Between the Functional Outcomes of Neuromodulation and Neuroablation Techniques for Treatment of Secondary Dystonia

Ain Shams University0 个研究点目标入组 120 人开始时间: 2013年12月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
120
主要终点
Burke-Fahn-Marsden dystonia rating scale

研究概览

简要总结

The disability inflected by dystonia encouraged the development of many neurosurgical procedures.

This is a prospective study included 120 patients suffering from intractable secondary dystonia.

They were subjected to different neurosurgical treatments and were assessed through the follow up period

详细描述

Background:

Secondary dystonia are the syndromes that have dystonic symptoms due to brain insult which can be associated with neonatal encephalopathy syndromes, trauma, vascular injury, infections, demyelinations, or hereditary disorders associated with neurodegenerative process. The disability inflected by dystonia encouraged the development of many neurosurgical procedures in order to improve the quality of life of these patients.

The aim of this study was to compare the outcomes of different Neuroablative and modulation techniques in treatment of secondary dystonia.

Patients and methods This is a prospective study included 120 patients suffering from intractable secondary dystonia. Ablative techniques included the brain lesioning procedure and combined anterior and posterior lumbar rhizotomy (CAPR). Modulation techniques included deep brain stimulation (DBS) and intrathecal baclofen therapy (ITB). Patients with focal dystonia were included in the Botulinum toxin injection group. Patients with generalized dystonia were included in either of the brain lesioning or the deep brain stimulation, and patients with predominant affection of both lower limbs were included in either of the (CAPR) or the (ITB) groups.

Assessment measures included the evaluation of the muscle tone, range of motion, and the Burke-Fahn-Marsden dystonia rating scale through a follow up period of one year.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
3 Years 至 50 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • secondary dystonia of previous etiologies

排除标准

  • patients who are not candidate for anaesthesia

研究组 & 干预措施

Brain lesioning group

Active Comparator

Stereotactic lesioning of the thalamus or gloves pallidus

干预措施: Brain Lesioning (Procedure)

Combined rhizotomy group

Active Comparator

Combined anterior and posterior lumbosacral rhizotomy

干预措施: Combined anterior and posterior lumbosacral rhizotomy (Procedure)

Deep brain stimulation group

Active Comparator

Bilateral globus pallidus internus deep brain stimulation

干预措施: Deep brain stimulation (Device)

Intra-thecal Baclofen infusion therapy

Active Comparator

Intra-thecal infusion pump

干预措施: Intra-thecal baclofen infusion (Device)

结局指标

主要结局

Burke-Fahn-Marsden dystonia rating scale

时间窗: 1 year

Dystonia rating scale Higher scores means a worse condition of the disease, while low scores indicate a less involvement of the body

次要结局

  • Barthel index(1 year)
  • Modified Ashworth scale(1 year)

研究者

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

Mohamed Nada

Fellow

Ain Shams University

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