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

Active, not recruiting

• Conditions: Multiple Sclerosis
• Interventions: Diagnostic Test: multimodal evoked potentials (mmEP)

• Registration Number: NCT03632473
• Lead Sponsor: University Hospital, Basel, Switzerland

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-12
• Study First Submitted: 2018-07-26
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-15
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26
• Primary Completion: 2024-04
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 29

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
clinically isolated syndrome (CIS)	multimodal evoked potentials (mmEP)	Multiple sclerosis (MS) with a clinically isolated syndrome (CIS) within six months of first clinical event. Multimodal evoked potentials (mmEP) assessments will take place at baseline, month 12 (from baseline), month 24 (from baseline) and month 36 (from baseline)
early relapsing-remitting late disease course (RRMS)	multimodal evoked potentials (mmEP)	MS with relapsing-remitting early disease course (RRMS) \</= 10 years, Expanded Disability Status Scale (EDSS) \</=3.5 EDSS: 1.0: No disability, minimal signs in 1 functional System (FS) 1.5: No disability, minimal signs in more than one FS 2.0: Minimal disability in one FS 2.5: Mild disability in one FS or minimal disability in two FS 3.0: Moderate disability in one FS, or mild disability in three or four FS. No impairment to Walking 3.5: Moderate disability in one FS and more than minimal disability in several others. No impairment to Walking. Multimodal evoked potentials (mmEP) assessments will take place at baseline, month 12 (from baseline), month 24 (from baseline) and month 36 (from baseline)
late relapsing-remitting late disease course (RRMS)	multimodal evoked potentials (mmEP)	MS with relapsing-remitting late disease course (late RRMS) of 5 to 15 years, EDSS: 2.0-5.5 inclusive EDSS: 4.0: Significant disability but self-sufficient and up and about some 12 hours a day. Able to walk without aid or rest for 500m 4.5: Significant disability but up and about much of the day, able to work a full day, may otherwise have some limitation of full activity or require minimal assistance. Able to walk without aid or rest for 300m 5.0: Disability severe enough to impair full daily activities and ability to work a full day without special provisions. Able to walk without aid or rest for 200m 5.5: Disability severe enough to preclude full daily activities. Able to walk without aid or rest for 100m. Multimodal evoked potentials (mmEP) assessments will take place at baseline, month 12 (from baseline), month 24 (from baseline) and month 36 (from baseline)
primary progressive disease course (PPMS)	multimodal evoked potentials (mmEP)	MS with a primary progressive disease course (PPMS) up to 15 years, EDSS: 2.0-6.5 inclusive EDSS: 6.0: Requires a walking aid - cane, crutch, etc. - to walk about 100m with or without resting 6.5: Requires two walking aids - pair of canes, crutches, etc. - to walk about 20m without resting. Multimodal evoked potentials (mmEP) assessments will take place at baseline, month 12 (from baseline), month 24 (from baseline) and month 36 (from baseline)

Primary Outcome Measures

Name	Time	Method
correlation of EP-sum-score (Σ-EP) and the Expanded Disability Status Scale (EDSS)	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

Trial Locations

Locations (3)

Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano; 🇨🇭 Lugano, Switzerland

Dep. of Neurology, Hospital of the University of Basel; 🇨🇭 Basel, Switzerland

Hopitaux universitaires de Genève; 🇨🇭 Geneva, Switzerland