跳至主要内容
临床试验/NL-OMON43584
NL-OMON43584已完成不适用

An observational study to evaluate driving competence in Huntington's disease - Evaluating driving competence in HD (Drive-HD)

Centre for Human Drug Research0 个研究点目标入组 90 人开始时间: 待定最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
90

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 至 99(—)

入选标准

  • All eligible subjects must meet the following inclusion criteria:
  • - be at least 18 years of age;
  • - possess a valid Dutch driver's licence;
  • - driven at least 300 km in the 12 months prior to study entry, to ensure regular driving activity.;Additional inclusion criteria HD manifest subjects
  • - confirmed CAG expansion of *36 in the HTT gene;
  • - UHDRS TMS >5.;Additional inclusion criteria for HD premanifest gene carriers
  • - confirmed CAG expansion of *36 in the HTT gene;
  • - UHDRS TMS *5, and no diagnosis in any other HD related domain (i.e. cognition or psychiatric).;Additional inclusion criteria for control subjects
  • - Gene negative for HD or no family history of HD, preferably spouses or relatives of HD subjects.

排除标准

  • All eligible subjects must meet none of the following exclusion criteria:
  • - Major comorbidities that are unrelated to HD (i.e. isolated psychiatric disorder, other neurological disorder, paralysis, ophthalmic disorder);
  • - Drug use (i.e. not medication) in the past 3 till 4 weeks prior to the visit day;
  • - Alcohol abuse (i.e. 3 or more glasses per day);
  • - Participation in intervention/clinical trials;
  • - Any other condition that in the opinion of the investigator warrants exclusion of the study.

研究者

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