Multiple SclerosisSMSCNCT03632473
Validation of Multimodal Evoked Potentials (mmEP) for Predicting Disease Progression in Multiple Sclerosis
An observational study of Multiple Sclerosis, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- multimodal evoked potentials (mmEP)
- How many people
- 29 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 28 Aug 2014to 26 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: MS patients participating in the Swiss Multiple Sclerosis Cohort Study (SMSC), regardless of MS-specific treatment
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Dep. of Neurology, Hospital of the University of Basel
Basel, 4031
Hopitaux universitaires de Genève
Geneva
Neurocenter of Southern Switzerland, Ospedale Regionale di Lugano
Lugano, 6903
About this study
Official title: Validation of Multimodal Evoked Potentials (mmEP) for Predicting Disease Progression in Multiple Sclerosis: Sub-study Within the Swiss Multiple Sclerosis Cohort (SMSC)
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
- Being tested
- multimodal evoked potentials (mmEP)
- Keywords
- Multimodal Evoked potentials, Visual evoked potentials, Somato-sensory evoked potentials, Motor evoked potentials, Expanded Disability Status Scale (EDSS)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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) Receives: 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) Receives: 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) Receives: Diagnostic Test: multimodal evoked potentials (mmEP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start28 Aug 2014
- Primary completion26 Jun 2020
- Study completion26 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Fuhr, Prof., Principal investigator, Dep. of Neurology, Hospital of the University of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03632473
- Sponsor's protocol ID
- 2016-01818; me14Fuhr
- Other IDs
- 2016
- Acronym
- SMSC
- Status last verified
- Sep 2024
- First submitted
- 26 Jul 2018
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35316624Hardmeier 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.
PubMed 33958567Hardmeier 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.
PubMed 32793104Hardmeier 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.
PubMed 31069107
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of Multimodal Evoked Potentials (mmEP) for Predicting Disease Progression in Multiple Sclerosis: Sub-study Within the Swiss Multiple Sclerosis Cohort (SMSC)
- ClinicalTrials.gov ID
- NCT03632473
- Acronym / sponsor ID
- SMSC / 2016-01818; me14Fuhr
- Conditions
- Multiple Sclerosis
- Keywords
- Multimodal Evoked potentials, Visual evoked potentials, Somato-sensory evoked potentials, Motor evoked potentials, Expanded Disability Status Scale (EDSS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 28 Aug 2014 (actual)
- Primary completion
- 26 Jun 2020 (actual)
- Study completion
- 26 Jun 2020 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Utility of Multimodal Evoked potentials (mmEP) for monitoring disease course and prediction of progression at different stages of Multiple Sclerosis (MS) is investigated
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| clinically isolated syndrome (CIS) | – | Diagnostic Test: 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) | – | Diagnostic Test: 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) | – | Diagnostic Test: 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) | – | Diagnostic Test: 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- MS patients participating in the Swiss Multiple Sclerosis Cohort Study (SMSC), regardless of MS-specific treatment
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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) | Diagnostic test | clinically isolated syndrome (CIS), early relapsing-remitting late disease course (RRMS), late relapsing-remitting late disease course (RRMS), primary progressive disease course (PPMS) |
Primary outcome
correlation of EP-sum-score (Σ-EP) and the Expanded Disability Status Scale (EDSS)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 35316624Hardmeier 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.
- Background: PubMed 33958567Hardmeier 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.
- Background: PubMed 32793104Hardmeier 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.
- Background: PubMed 31069107Hardmeier 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Fuhr, Prof. principal investigator
Dep. of Neurology, Hospital of the University of Basel
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by University Hospital, Basel, Switzerland at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation of EP-sum-score (Σ-EP) and the Expanded Disability Status Scale (EDSS) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03632473, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.