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

Multiple Sclerosis Clinical Trial

— SMSC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03632473
• Other study ID #: 2016-01818; me14Fuhr
• Status: Active, not recruiting
• Start date: March 12, 2015
• Est. completion date: July 2024

Study information

• Verified date: January 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 29
• Est. completion date: July 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Disease Progression
• Multiple Sclerosis
• Sclerosis

Intervention

Diagnostic Test:
• 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)

Locations

Country	Name	City	State
Switzerland	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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	correlation of EP-sum-score (S-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