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临床试验/DRKS00024898
DRKS00024898招募中4 期

Cognitive Training & a Healthy, Active Lifestyle Program for Patients with isolated REM-Sleep Behavior Disorder: CogTrAiL-RBD - CogTrAiL-RBD

niversität zu Köln0 个研究点目标入组 80 人开始时间: 2022年3月11日最近更新:
适应症

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
80

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
40 Years 至 80 Years(—)
性别
All

入选标准

  • Patients with iRBD:
  • PSG-proven diagnosis of iRBD, which indicates a high probability for phenoconversion to Parkinson’s disease (ICD-10 G20) according to the criteria of the Movement Disorder Society (Berg et al., 2015; Heinzel et al., 2019) and the risk for developing mild cognitive impairment (ICD-10 F06.7)
  • Age between 40-80 years
  • Normal or corrected-to-normal vision and hearing
  • German as native tongue or sufficient German language proficiency
  • Sufficient computer knowledge and access to a local (laptop) computer with access to the internet
  • Healthy control group:
  • Age between 40-80 years
  • Normal or corrected-to-normal vision and hearing
  • German as native tongue or sufficient German language proficiency

排除标准

  • Patients with iRBD:
  • Severe cognitive dysfunction (MoCA = 22)
  • Limited resp. No capacity to consent
  • Significant concomitant neurological and psychiatric resp. life-threatening diseases (e.g. acute episodes of mood disorders, personality disorders, psychoses or somatoform disorder)
  • Additionally for those patients who consent to participate in MRI-measurement:
  • Contraindications for MRI
  • o Objects in or at one’s body that are MRI-incompatible and indelible (e.g. neurostimulator, pacemaker, grinding work on metal)
  • o Big tattoos (above 20cm)
  • o Actual or possible pregnancy
  • o Fear of tight spaces
  • Healthy control group:
  • Severe cognitive dysfunction (MoCA = 22)
  • Limited resp. No capacity to consent
  • Significant concomitant neurological and psychiatric resp. life-threatening diseases (e.g. acute episodes of mood disorders, personality disorders, psychoses or somatoform disorder)
  • Contraindications for MRI

研究者

发起方
niversität zu Köln

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