Comparative Study Between the Functional Outcomes of Neuromodulation and Neuroablation Techniques for Treatment of Secondary Dystonia
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
- 否
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
Stereotactic lesioning of the thalamus or gloves pallidus
干预措施: Brain Lesioning (Procedure)
Combined rhizotomy group
Combined anterior and posterior lumbosacral rhizotomy
干预措施: Combined anterior and posterior lumbosacral rhizotomy (Procedure)
Deep brain stimulation group
Bilateral globus pallidus internus deep brain stimulation
干预措施: Deep brain stimulation (Device)
Intra-thecal Baclofen infusion therapy
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
Mohamed Nada
Fellow
Ain Shams University
