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
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