跳至主要内容
临床试验/NCT01728428
NCT01728428已完成不适用

A Multicenter, Observational Study to Evaluate Clinical Manifestation, Diagnosis and Treatment of Primary Hemifacial Spasm in Chinese Patients

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 1,003 人开始时间: 2012年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
1,003
试验地点
1
主要终点
The percentage of the treatment methods of HFS in outpatient subjects

研究概览

简要总结

To determine the clinical manifestation, diagnosis and treatment options of primary hemifacial spasm in Chinese outpatient subjects

详细描述

About 1000 outpatient subjects will be recruited. The inclusion criteria include clinically diagnosed primary hemifacial spasm, male or female 18 to 80 years old and informed consent has been obtained. The exclusion criteria include secondary hemifacial spasm, other involuntary facial movement disorder, history of surgery of microvascular decompression of the facial nerve and so on. The outcome measures include the percentage of the treatment methods of HFS in outpatient subjects, aggrevated and relieved factors of HFS symptom, concomitant symptoms of HFS and adverse events of botulinum toxin treatment in HFS patients.

研究设计

研究类型
Observational
时间视角
Retrospective

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

入选标准

  • 1.Clinically diagnosed primary hemifacial spasm
  • Tonic and clonic contractions of muscles innervated by the unilateral facial nerve.
  • No other neurological disorder. 2.Male or female 18 to 80 years old 3.Informed consent has been obtained

排除标准

  • Secondary hemifacial spasm: brainstem tumor, surgery, facial neuritis and so on.
  • Other involuntary facial movement disorder: facial synkinesia after facial palsy, tics, myokymia and focal motor seizures.
  • History of surgery of microvascular decompression of the facial nerve.
  • Participation in another clinical study currently.
  • Not able to understand and answer questionnaire.
  • Investigator's opinion that the subject has a concurrent condition(s) that may confound the study results.

结局指标

主要结局

The percentage of the treatment methods of HFS in outpatient subjects

时间窗: November, 2012

次要结局

  • Distribution of onset age of hemifacial spasm patients(November, 2012)
  • Analysis of aggrevated and relieved factors of HFS symptom(November, 2012)
  • Analysis of concomitant symptoms of hemifacial spasm(November, 2012)
  • Adverse events of botulinum toxin treatment in hemifacial spasm(November, 2012)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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