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临床试验/EUCTR2016-004629-18-NL
EUCTR2016-004629-18-NL进行中(未招募)1 期

The noradrenergic basis of Parkinson’s tremor: a systems-level fMRI approach - Noradrenergic basis of Parkinson tremor

Radboud University Nijmegen0 个研究点目标入组 60 人开始时间: 2017年1月17日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
60

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - idiopathic Parkinson’s disease according to UK Brain Bank criteria
  • - tremor-­dominant phenotype (defined as a resting tremor score of >= 2 UPDRS points for at least one arm)
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 30
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 30

排除标准

  • -use of beta-blockers
  • -neuropsychiatric co-morbidity
  • -contraindications for MRI scanning (e.g. pacemaker, implanted metal parts, deep brain stimulation, claustrophobia)
  • -Cardiac arrhythmias (in patient history or visible on ECG)
  • -contraindications for beta blockers (e.g. bradycardia, peripheral circulation disturbances, asthma or obstructive lung disease, hypotension)
  • -Use of medication that may interact with propranolol, e.g. other bèta-blockers, calcium antagonists, digoxine, cimetidine, hydralazine, fluvoxamine, rifampicine, barbiturates, amiodaron, flecainide, kinidine, propafenon, disopyramide, chlorpromazine, and clonidine
  • -Use of medication that inhibits relevant CYP enzymes that are involved in metabolizing propranolol (CYP2D6, CYP1A2, and CYP2C19): fluoxetine, paroxetine, sertraline, duloxetine, terbinafine, cinacalcet, bupropion, and ciprofloxacine
  • -Severe head tremor or dyskinesias
  • -Cognitive impairment (MMSE < 26)

研究者

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