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

NCT ID: NCT03632473

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 29 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-08-28
• Study Completion Date: 2020-06-26

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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)

multimodal evoked potentials (mmEP)

Intervention Type: 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)

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)

multimodal evoked potentials (mmEP)

Intervention Type: 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)

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)

multimodal evoked potentials (mmEP)

Intervention Type: 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 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)

multimodal evoked potentials (mmEP)

Intervention Type: 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)

Interventions

multimodal evoked potentials (mmEP)

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

Intervention Type: DIAGNOSTIC_TEST

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Fuhr, Prof.

Role: PRINCIPAL_INVESTIGATOR

Dep. of Neurology, Hospital of the University of Basel

Locations

Dep. of Neurology, Hospital of the University of Basel

Basel, , Switzerland

Hopitaux universitaires de Genève

Geneva, , Switzerland

Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano

Lugano, , Switzerland

Countries

Switzerland

References

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.

Reference Type: BACKGROUND

PMID: 35316624 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33958567 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32793104 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31069107 (View on PubMed)

Other Identifiers

2016-01818; me14Fuhr

Identifier Type: -

Identifier Source: org_study_id