Clinical trial NCT03632473: Validation of Multimodal Evoked Potentials (mmEP) for Predicting Disease Progression in Multiple Sclerosis
Official title: Validation of Multimodal Evoked Potentials (mmEP) for Predicting Disease Progression in Multiple Sclerosis: Sub-study Within the Swiss Multiple Sclerosis Cohort (SMSC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multimodal Evoked potentials
Visual evoked potentials
Somato-sensory evoked potentials
Motor evoked potentials
Expanded Disability Status Scale (EDSS)
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 29
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: MS patients participating in the Swiss Multiple Sclerosis Cohort Study (SMSC), regardless of MS-specific treatment

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


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)

Primary outcomes:
measure: correlation of EP-sum-score (Σ-EP) and the Expanded Disability Status Scale (EDSS)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Dep. of Neurology, Hospital of the University of Basel
city: Geneva
country: Switzerland
facility: Hopitaux universitaires de Genève
city: Lugano
country: Switzerland
facility: Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano
Study officials:
affiliation: Dep. of Neurology, Hospital of the University of Basel
name: Peter Fuhr, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.