跳至主要内容
临床试验/NCT03562403
NCT03562403Unknown不适用

Deep Brain Stimulation in the Treatment of Intractable Movement Disorders ( Parkinson's Disease, Essential Tremors and Dystonia)

Assiut University0 个研究点目标入组 16 人开始时间: 2018年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
16
主要终点
Change in the unified parkinson's disease rating scale score

研究概览

简要总结

The aim of this study is to observe the efficacy of Deep Brain Stimulation in the treatment of Parkinson's disease,Essential Tremors and Dystonia in our locality.

详细描述

Movement disorders are clinical syndromes result from disturbances of basal ganglia function with either an excess of movement or a paucity of voluntary and involuntary movements, unrelated to weakness or spasticity. Movement disorders are synonymous with basal ganglia or extrapyramidal diseases. Movement disorders are conventionally divided into two major categories-hyperkinetic and hypokinetic.

Hyperkinetic movement disorders refer to excessive, often repetitive, involuntary movements that intrude upon the normal flow of motor activity and it includes include Essential Tremors, Dystonia, Chorea, Dyskinesia, and Athetosis.

Hypokinetic movement disorders refer to akinesia (lack of movement), hypokinesia (reduced amplitude of movements), bradykinesia (slow movement) and rigidity. In primary movement disorders, the abnormal movement is the primary manifestation of the disorder. In secondary movement disorders, the abnormal movement is a manifestation of another systemic or neurological disorder.

The basal ganglia include the striatum (caudate. putamen, nucleus accumbens), the subthalamic nucleus (STN), the globuspallidus [internal segment. external segment, ventral pallidum (VP)]. and the substantianigra pars compacta (SNpc) and substantianigra pars reticulata (SNpr).

Surgical therapies for the treatment of movement disorders can be divided into two broad categories: ablative and restorative. The most common structures targeted during stereotactic surgery for movement disorders are the motor thalamus, the globuspallidus internus and the subthalamic nucleus. Ablative surgical therapies for Movement disorders include thalamotomy and pallidotomy. Restorative surgical therapies include deep brain stimulation and transplantation of fetal tissue, cell lines that express trophic factors, or somatically delivered gene therapies. The theoretical advantage of Deep Brain Stimulation over ablative procedures is the lack of tissue destruction especially with deep brain stimulation. This is particularly appealing for patients needing bilateral procedures.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Dopa responsiveness
  • Minimum disease duration of 5 years.
  • Diagnosis of idiopathic Parkinsons disease
  • Patients with intractable Essential Tremors.
  • Patients with intractable dystonia

排除标准

  • Significant medical health problems.
  • Significant cognitive impairment
  • Bleeding tendencies

研究组 & 干预措施

DBS on patients with abnormal movement disorders

Experimental

16 patients with intractable abnormal movement disorders (Parkinson's disease, Essential tremors and Dystonia)

干预措施: Deep Brain Stimulation (Device)

结局指标

主要结局

Change in the unified parkinson's disease rating scale score

时间窗: baseline(pre-DBS )and 6 months post-DBS

The Unified Parkinson's Disease Rating Scale (UPDRS) is a commonly used survey tool used to assess symptom severity of patients with Parkinson's disease (PD). It covers several different domains including 1) thought, behavior and mood 2) activities of daily living 3) motor activity 4) complications of therapy and others. Part I: evaluation of mentation, behavior, and mood Part II: self-evaluation of the activities of daily life (ADLs) including speech, swallowing, handwriting, dressing, hygiene, falling, salivating, turning in bed, walking, and cutting food Part III: clinician-scored monitored motor evaluation Part IV: complications of therapy Part V: Hoehn and Yahr staging of severity of Parkinson's disease Part VI: Schwab and England ADL scale

次要结局

  • Change in antiparkinsonian medication use(baseline(pre-DBS and 6 months post-DBS)

研究者

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

Ahmed Radwan Nouby

Assistant Lecturer in the Department of Neurosurgery

Assiut University

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