NCT05561621已完成不适用
Prediction of Non-motor Symptoms in Fully Ambulatory MS Patients Using Vocal Biomarkers
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Identification of a voice signature that separates between pwMS with and without fatigue
研究概览
简要总结
The investigator will set up a study evaluating vocal biomarkers in people with MS in order to identify persons with non-motor symptoms: depression, cognitive deterioration, and fatigue. Up to now, to the best of the investigator's knowledge, there is no study reporting the use of vocal biomarkers to predict these three non-motor symptoms in people with MS.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Relapsing MS
- •Age over 18
- •EDSS < 4.0
- •Capability of written informed consent
排除标准
- •Not fluent in german language
- •Relapse or Steroids per os/intra venous < 4 weeks prior to examination
- •KM enhancing lesion in MRI < 4 weeks prior to examination
- •Other previous disease affecting the speech
- •Pregnant patients
- •Mental disability and not able to understand the protocol and study tasks in german languagePatients with greater physical and cognitive disability or history of major depressive disorder and suicide attempt/suicidal thoughts
- •Patients with sleep disorders and comorbidities associated with extreme fatigue (e.g., fibromyalgia)
结局指标
主要结局
Identification of a voice signature that separates between pwMS with and without fatigue
时间窗: One year
次要结局
- Identification of a voice signature that separates between pwMS with and without depression(One year)
- Identification of a voice signature that separates between pwMS with and without cognitive impairment(One year)
研究者
研究点 (1)
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