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

NCT03632473 | Completed

• 1 other identifier: 2016-01818; me14Fuhr
• Study Type: observational
• Target: 29
• Locations: 1 country
• Sites: 3

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

Conditions

Multiple Sclerosis

Keywords

Multimodal Evoked potentials; Visual evoked potentials; Somato-sensory evoked potentials; Motor evoked potentials; Expanded Disability Status Scale (EDSS)

Outcome Measures

Primary Outcomes (1)

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

  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

  3 years

Study Arms (4)

clinically isolated syndrome (CIS)

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)

Diagnostic Test: multimodal evoked potentials (mmEP)

early relapsing-remitting late disease course (RRMS)

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)

Diagnostic Test: multimodal evoked potentials (mmEP)

late relapsing-remitting late disease course (RRMS)

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)

Diagnostic Test: multimodal evoked potentials (mmEP)

primary progressive disease course (PPMS)

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)

Diagnostic Test: multimodal evoked potentials (mmEP)

Interventions

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)

clinically isolated syndrome (CIS); early relapsing-remitting late disease course (RRMS); late relapsing-remitting late disease course (RRMS); primary progressive disease course (PPMS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

MS patients participating in the Swiss Multiple Sclerosis Cohort Study (SMSC), regardless of MS-specific treatment

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (3)

Dep. of Neurology, Hospital of the University of Basel

Basel, 4031, Switzerland

Location

Hopitaux universitaires de Genève

Geneva, Switzerland

Location

Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano

Lugano, 6903, Switzerland

Location

Related Publications (4)

• Hardmeier M, Schlaeger R, Lascano AM, Toffolet L, Schindler C, Gobbi C, Lalive P, Kuhle J, Kappos L, Fuhr P. Prognostic biomarkers in primary progressive multiple sclerosis: Validating and scrutinizing multimodal evoked potentials. Clin Neurophysiol. 2022 May;137:152-158. doi: 10.1016/j.clinph.2022.02.019. Epub 2022 Mar 7.

  PMID: 35316624 BACKGROUND

• Hardmeier M, Fuhr P. Multimodal Evoked Potentials as Candidate Prognostic and Response Biomarkers in Clinical Trials of Multiple Sclerosis. J Clin Neurophysiol. 2021 May 1;38(3):171-180. doi: 10.1097/WNP.0000000000000723.

  PMID: 33958567 BACKGROUND

• Hardmeier M, Schindler C, Kuhle J, Fuhr P. Validation of Quantitative Scores Derived From Motor Evoked Potentials in the Assessment of Primary Progressive Multiple Sclerosis: A Longitudinal Study. Front Neurol. 2020 Jul 24;11:735. doi: 10.3389/fneur.2020.00735. eCollection 2020.

  PMID: 32793104 BACKGROUND

• Hardmeier M, Jacques F, Albrecht P, Bousleiman H, Schindler C, Leocani L, Fuhr P. Multicentre assessment of motor and sensory evoked potentials in multiple sclerosis: reliability and implications for clinical trials. Mult Scler J Exp Transl Clin. 2019 May 1;5(2):2055217319844796. doi: 10.1177/2055217319844796. eCollection 2019 Apr-Jun.

  PMID: 31069107 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Peter Fuhr, Prof.

  Dep. of Neurology, Hospital of the University of Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2018
• First Posted: August 15, 2018
• Study Start: August 28, 2014
• Primary Completion: June 26, 2020
• Study Completion: June 26, 2020
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CH (3)