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Clinical Trials/NCT03632473
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

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

Registry
clinicaltrials.gov
Start Date
March 12, 2015
End Date
July 2024
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Basel, Switzerland
Responsible Party
Sponsor

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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