Electrophysiological Studies of Auditory Functions and CSF Analyses in Patients With Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Auditory functions and correlation with CSF findings
研究概览
简要总结
The study will analyze the auditory functions of patients with Multiple Sclerosis using auditory tests like pure tone auditory test, speech perception test, Auditory Brain Response (ABR) and Distortion Product Otoacustic Emission (DPOAE). CSF will be collected by lumbar puncture and analyzed looking for inflammatory markers.
The results of DPOAE and CSF will be correlated to identify statistically significant correlation.
详细描述
Case-Control study
Tools for patients' selection and inclusion in the study
STEP one
- Full medical records detailed for neurological diseases
- Brain and spinal cord MRI performed 12 months (n1) before and most recent one (n2)
- Lumbar puncture
- Blood test
- Questionnaire for screening hearing disorders
- App for screening hearing loss
STEP two
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age >18 and <50,
- •no history of hearing loss,
- •no psychiatric condition
- •no familial history of otosclerosis/deafness/genetic hearing loss
- •patients with PD and/or MS.
排除标准
- •Conductive hearing loss
- •stroke < 2 years
- •cardiovascular disease non under control
- •hypotensive disorders
- •alcohol abuse
- •recreational drug consumption
结局指标
主要结局
Auditory functions and correlation with CSF findings
时间窗: 12 months
The worsening of the hearing thresholds and DPOAE results will be correlated with the presence of inflammatory elements in the CSF
次要结局
未报告次要终点
研究者
Arianna Di Stadio
Associate Professor fixed time
University of Catania