Multiple SclerosisEP-BNCT03686826
Feasibility and Reliability of Multimodal Evoked Potentials
An observational study of Multiple Sclerosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Multimodal Evoked potentials (mmEP) reflect disease course of multiple sclerosis (MS) and are potentially suited as a biomarker for disease progression. The acquisition of evoked potentials (EP) in this observatory trial is to evaluate the feasibility and test-retest reliability of motor and somato-sensory EP (MEP and… Read more about this study
- Who is it for?
- Ages 18 to 58 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Acquisition of MEP und SSEP
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 6 Sep 2016to 31 Dec 2018
- 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 to 58 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients with MS will be recruited from the outpatient clinic at the University Hospital Basel as consecutive ongoing recruitment through project leader and Co-workers in daily clinical practice. Healthy subjects will be recruited by bulletin on notice-boards in the hospital
Who may be able to join
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- Have no significant health issues, ie neuropathy or other demyelinating disorder that can affect testing.
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations
- Diagnosis of MS (all types) with an expanded disability status scale (EDSS) 0.0 to 6.5
- Have measurable responses on both MEP and SSEP in at least one upper and one lower limb on visit 2. The MEP and SSEP responses do not need to be in the same limb
- Have no comorbid condition (ie neuropathy) that could affect testing
Who cannot join
- Inability to comply with study requirements
- Unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment
- Any diseases (e.g., non-MS demyelinating diseases), with the exception of diagnosis MS for the MS Cohort, that in the opinion of the Investigator, could influence evoked potential results (including but not limited to medullary trauma, morbid obesity, limb amputation, diabetes, other polyneuropathy)
- Conditions interfering with magnetic stimulation (including but not limited to epilepsy, movable metal implants in the body such as pacemakers or stents)
- MS relapse within 3 months of either sessions
- Initiation of treatment or dose adjustment within 1 month of either sessions with 4-Aminopyridin, Carbamazepine, Baclofen, Tizianid
- Febrile illness within 3 days of either sessions.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of Neurology, Hospital of the University of Basel
Basel, 4031
About this study
Multimodal Evoked potentials (mmEP) reflect disease course of multiple sclerosis (MS) and are potentially suited as a biomarker for disease progression.
The acquisition of evoked potentials (EP) in this observatory trial is to evaluate the feasibility and test-retest reliability of motor and somato-sensory EP (MEP and SSEP) in an international multicenter setting in healthy subjects and subjects with multiple sclerosis (MS).
Read the detailed description
Multimodal EP (mmEP) is being developed as a predictive biomarker to determine the clinical response to therapy. MEP and SSEP contributes significantly to the predictive value of mmEP. The variability of MEP and SSEP has limited its use in multicenter clinical trials. Recent technological advances and standardization of procedures has decreased the variability. The objective of this study is to evaluate the reliability of MEP and SSEP and feasibility of performing MEP and SSEP in an international, multicenter setting. Establishment of the reliability and feasibility of MEP and SSEP will allow for further development of this predictive biomarker in future clinical trials.
- Conditions
- Multiple Sclerosis
- Being tested
- Acquisition of MEP und SSEP
- Keywords
- evoked potentials (EP), motor evoked potentials (MEP), Somato-sensory evoked potentials (SSEP), multimodal evoked potentials (mmEP)
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acquisition of MEP und SSEPProcedure or surgery
Acquisition of MEP und SSEP at two different time points within 1 to 30 days
| Study group | Role | What they receive |
|---|---|---|
| multiple sclerosis patients | Not described Receives: Procedure: Acquisition of MEP und SSEP | |
| healthy volunteers | Not described Receives: Procedure: Acquisition of MEP und SSEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraclass correlation coefficient (ICC) of MEP and SSEP
The primary analysis will be a descriptive statistical summary of MEP and SSEP results at the first session, the second session and overall. Intraclass correlation coefficients (ICC) will be calculated to assess the test-retest reliability between consecutive measurements and the interrater reliability between raters.
Measured: time between Visit 1 (= Baseline = Day 0) and Visit 2 (= 1 day to 30 days after Visit 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start6 Sep 2016
- Primary completion15 Sep 2017
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Fuhr, Prof. Dr. MD, Principal investigator, University Hospital Basel; Department of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03686826
- Sponsor's protocol ID
- 2016-01099; me16Fuhr2
- Other IDs
- 2016
- Acronym
- EP-B
- Status last verified
- Jan 2019
- First submitted
- 25 Sep 2018
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Reliability of Multimodal Evoked Potentials
- ClinicalTrials.gov ID
- NCT03686826
- Acronym / sponsor ID
- EP-B / 2016-01099; me16Fuhr2
- Conditions
- Multiple Sclerosis
- Keywords
- evoked potentials (EP), motor evoked potentials (MEP), Somato-sensory evoked potentials (SSEP), multimodal evoked potentials (mmEP)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 6 Sep 2016 (actual)
- Primary completion
- 15 Sep 2017 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 27 Sep 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.
Multimodal Evoked potentials (mmEP) reflect disease course of multiple sclerosis (MS) and are potentially suited as a biomarker for disease progression.
The acquisition of evoked potentials (EP) in this observatory trial is to evaluate the feasibility and test-retest reliability of motor and somato-sensory EP (MEP and SSEP) in an international multicenter setting in healthy subjects and subjects with multiple sclerosis (MS).
Detailed description
Multimodal EP (mmEP) is being developed as a predictive biomarker to determine the clinical response to therapy. MEP and SSEP contributes significantly to the predictive value of mmEP. The variability of MEP and SSEP has limited its use in multicenter clinical trials. Recent technological advances and standardization of procedures has decreased the variability. The objective of this study is to evaluate the reliability of MEP and SSEP and feasibility of performing MEP and SSEP in an international, multicenter setting. Establishment of the reliability and feasibility of MEP and SSEP will allow for further development of this predictive biomarker in future clinical trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| multiple sclerosis patients | – | Procedure: Acquisition of MEP und SSEP |
| healthy volunteers | – | Procedure: Acquisition of MEP und SSEP |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients with MS will be recruited from the outpatient clinic at the University Hospital Basel as consecutive ongoing recruitment through project leader and Co-workers in daily clinical practice. Healthy subjects will be recruited by bulletin on notice-boards in the hospital
Key inclusion criteria (6 listed)
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- Have no significant health issues, ie neuropathy or other demyelinating disorder that can affect testing.
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations
- Diagnosis of MS (all types) with an expanded disability status scale (EDSS) 0.0 to 6.5
- Have measurable responses on both MEP and SSEP in at least one upper and one lower limb on visit 2. The MEP and SSEP responses do not need to be in the same limb
Key exclusion criteria (7 listed)
- Inability to comply with study requirements
- Unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment
- Any diseases (e.g., non-MS demyelinating diseases), with the exception of diagnosis MS for the MS Cohort, that in the opinion of the Investigator, could influence evoked potential results (including but not limited to medullary trauma, morbid obesity, limb amputation, diabetes, other polyneuropathy)
- Conditions interfering with magnetic stimulation (including but not limited to epilepsy, movable metal implants in the body such as pacemakers or stents)
- MS relapse within 3 months of either sessions
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 |
|---|---|---|
| Acquisition of MEP und SSEPAcquisition of MEP und SSEP at two different time points within 1 to 30 days | Procedure or surgery | healthy volunteers, multiple sclerosis patients |
Primary outcome
intraclass correlation coefficient (ICC) of MEP and SSEP
Time frame: time between Visit 1 (= Baseline = Day 0) and Visit 2 (= 1 day to 30 days after Visit 1)
The primary analysis will be a descriptive statistical summary of MEP and SSEP results at the first session, the second session and overall. Intraclass correlation coefficients (ICC) will be calculated to assess the test-retest reliability between consecutive measurements and the interrater reliability between raters.
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 23 Jan 2019.
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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. Dr. MD principal investigator
University Hospital Basel; Department of Neurology
1 site 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 1 site 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 6 inclusion and 7 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 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
intraclass correlation coefficient (ICC) of MEP and SSEP (time frame: time between Visit 1 (= Baseline = Day 0) and Visit 2 (= 1 day to 30 days after Visit 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2019.