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Completed

NCT Number: NCT03632473

Validation of Multimodal Evoked Potentials (mmEP) for Predicting Disease Progression in Multiple Sclerosis

Utility of Multimodal Evoked potentials (mmEP) for monitoring disease course and prediction of progression at different stages of Multiple Sclerosis (MS) is investigated

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dep. of Neurology, Hospital of the University of Basel, Basel, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

multimodal evoked potentials (mmEP)

Diagnostic Test

combination of visual evoked potentials (VEP) and motor evoked potentials (MEP) or the combination of VEP, MEP and somato-sensory evoked potentials (SSEP)

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

Validation of Multimodal Evoked Potentials (mmEP) for Predicting Disease Progression in Multiple Sclerosis: Sub-study Within the Swiss Multiple Sclerosis Cohort (SMSC)

Acronym: SMSC

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Aug 15, 2018
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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