跳至主要内容
临床试验/NCT00311909
NCT00311909已完成2 期

Thalamic Deep Brain Stimulation for Tourette Syndrome: A Prospective Clinical Trial

University Hospitals Cleveland Medical Center2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2005年6月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
5
试验地点
2
主要终点
modified Rush Video Rating Scale (mRVRS)

研究概览

简要总结

The purpose of this study is to determine whether deep brain stimulation is effective at reducing tic frequency and severity in adults with Tourette syndrome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double

入排标准

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

入选标准

  • age 18 or older
  • Diagnosis of Tourette Syndrome by DSM-IV
  • Tic frequency at least one per minute at screening
  • prior failure of at least two dopamine receptor or presynaptic blockers
  • negative impact on quality of life

排除标准

  • significant structural brain lesion (on imaging studies)
  • significant dementia
  • severe head trauma preceding onset of tics
  • use of dopamine receptor blockers prior to recognition of tics
  • prior implanted electrical device
  • electroconvulsive therapy (ECT) within 24 months
  • suicide attempt within 12 months
  • significant sociopathic personality
  • current or planned pregnancy

结局指标

主要结局

modified Rush Video Rating Scale (mRVRS)

次要结局

  • SF-36
  • Yale Global Tourette Severity Scale (YGTSS)
  • Quality of Life Visual Analog Scale (VAS)
  • Neuropsychological battery
  • tic counts (on video recording)
  • Tourette Syndrome Symptom List (TSSL)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验