NCT03632473
Active, not recruiting
Not Applicable
Validation of Multimodal Evoked Potentials (mmEP) for Predicting Disease Progression in Multiple Sclerosis: Sub-study Within the Swiss Multiple Sclerosis Cohort (SMSC)
University Hospital, Basel, Switzerland3 sites in 1 country29 target enrollmentMarch 12, 2015
ConditionsMultiple Sclerosis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Multiple Sclerosis
- Sponsor
- University Hospital, Basel, Switzerland
- Enrollment
- 29
- Locations
- 3
- Primary Endpoint
- correlation of EP-sum-score (Σ-EP) and the Expanded Disability Status Scale (EDSS)
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
Utility of Multimodal Evoked potentials (mmEP) for monitoring disease course and prediction of progression at different stages of Multiple Sclerosis (MS) is investigated
Investigators
Eligibility Criteria
Inclusion Criteria
- •diagnosed with a clinically isolated syndrome (CIS) or MS with a relapsing-remitting (RRMS) or a primary progressive disease course (PPMS):
- •CIS: EDSS \<= 5.5 within six months of first clinical event
- •early RRMS: EDSS: \<= 3.5 disease course of 5 up to 10 years
- •late RRMS: EDSS: 2.0-5.5 inclusive disease course of 5 to 15 years
- •PPMS: EDSS: 2.0-6.5 inclusive disease course up to 15 years
- •participation in the Swiss Multiple Sclerosis Cohort Study (SMSC)
- •mental ability to cooperate
- •written informed consent
Exclusion Criteria
- •alcohol or substance abuse
- •progressive disease other than Multiple Sclerosis
- •psychiatric disorder requiring a treatment by a psychiatrist
- •patients with movable metal implants, e.g. pace-maker, stents, deep brain stimulators etc.;(patients with jaw- or bone-fixed metal implants can be included)
Outcomes
Primary Outcomes
correlation of EP-sum-score (Σ-EP) and the Expanded Disability Status Scale (EDSS)
Time Frame: 3 years
logistic regression model will be used to predict worsening in EDSS defined by a 1-point-change (0.5 if EDSS is 5.5 or higher) at year 3
Study Sites (3)
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