Feasibility and Reliability of Multimodal Evoked Potentials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- intraclass correlation coefficient (ICC) of MEP and SSEP
研究概览
简要总结
Multimodal Evoked potentials (mmEP) reflect disease course of multiple sclerosis (MS) and are potentially suited as a biomarker for disease progression.
The acquisition of evoked potentials (EP) in this observatory trial is to evaluate the feasibility and test-retest reliability of motor and somato-sensory EP (MEP and SSEP) in an international multicenter setting in healthy subjects and subjects with multiple sclerosis (MS).
详细描述
Multimodal EP (mmEP) is being developed as a predictive biomarker to determine the clinical response to therapy. MEP and SSEP contributes significantly to the predictive value of mmEP. The variability of MEP and SSEP has limited its use in multicenter clinical trials. Recent technological advances and standardization of procedures has decreased the variability. The objective of this study is to evaluate the reliability of MEP and SSEP and feasibility of performing MEP and SSEP in an international, multicenter setting. Establishment of the reliability and feasibility of MEP and SSEP will allow for further development of this predictive biomarker in future clinical trials.
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 58 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Inability to comply with study requirements
- •Unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment
- •Any diseases (e.g., non-MS demyelinating diseases), with the exception of diagnosis MS for the MS Cohort, that in the opinion of the Investigator, could influence evoked potential results (including but not limited to medullary trauma, morbid obesity, limb amputation, diabetes, other polyneuropathy)
- •Conditions interfering with magnetic stimulation (including but not limited to epilepsy, movable metal implants in the body such as pacemakers or stents)
- •MS relapse within 3 months of either sessions
- •Initiation of treatment or dose adjustment within 1 month of either sessions with 4-Aminopyridin, Carbamazepine, Baclofen, Tizianid
- •Febrile illness within 3 days of either sessions.
结局指标
主要结局
intraclass correlation coefficient (ICC) of MEP and SSEP
时间窗: time between Visit 1 (= Baseline = Day 0) and Visit 2 (= 1 day to 30 days after Visit 1)
The primary analysis will be a descriptive statistical summary of MEP and SSEP results at the first session, the second session and overall. Intraclass correlation coefficients (ICC) will be calculated to assess the test-retest reliability between consecutive measurements and the interrater reliability between raters.
次要结局
未报告次要终点