Multiple SclerosisNCT03047460
Feasibility and Reliability of Multimodal Evoked Potentials in an International Multicenter Setting
An observational study of Multiple Sclerosis, run by Clinique Neuro-Outaouais at 1 site in Canada.
Trial summary
Study Objectives and Endpoints: Objective: The primary objective of the study is to evaluate the feasibility and test-retest reliability of MEP's and (SSEP's) in a multicenter clinical trial in healthy subjects and subjects with MS. 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?
- multimodal evoked potentials
- How many people
- 14 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to Jan 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: Healthy volunteers and MS patients aged 18 to 58 that have no other neurological comorbities that could affect evoked potential responses
Who may be able to join
- To be eligible to participate in this study, candidates must meet the following eligibility criteria at Screening, or at the time point specified in the individual eligibility criterion listed (HV cohort):
- 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.
- Aged 18 to 58 years old, inclusive, at the time of informed consent.
- Have no significant health issues, ie neuropathy or other demyelinating disorder that can affect testing.
- To be eligible to be included in this cohort, candidates must meet the following additional eligibility criteria at Screening:
- 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.
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- Aged 18 to 58 years old, inclusive, at the time of informed consent.
- 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. 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
- Candidates will be excluded from study entry if any of the following exclusion criteria exist at screening or at any time during the study.
- 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).
- MS relapse within 3 months of either sessions.
- Initiation of treatment or dose adjustment within 1 month of either sessions with Fampyra, Tegretol, Baclofen, Zanaflex
- Febrile illness within 3 days of either sessions.
Trial locations and contacts
1 site in 1 country.
About this study
Study Objectives and Endpoints:
Objective:
The primary objective of the study is to evaluate the feasibility and test-retest reliability of MEP's and (SSEP's) in a multicenter clinical trial in healthy subjects and subjects with MS.
Endpoints:
The primary reliability endpoint will be the intraclass correlation coefficient (ICC) of the following evoked potential parameters
Read the detailed description
The establishment of a biomarker(s) that can predict a clinical response to therapy over the course of a 1-2 year clinical trial is critical for the expeditious development of treatments for Multiple Sclerosis (MS). Identification of this biomarker would enable shorter and smaller clinical trials resulting in the faster development of much needed treatments for MS, specifically neuro-reparative therapies. The etiology of disease progression is conduction block, demyelination and axonal degeneration. Evoked potentials provide a direct assessment of the underlying etiologies of disease progression in MS. They are a functional assessment of multiple pathways, including visual, motor and sensory, evaluating the integrity of myelin and axons.
The variability of motor evoked potentials (MEP) measures has limited multimodal evoked potential (mmEP) use in international, multicenter clinical trials. MEP evaluation does significantly contribute to the predictive value of mmEP's. Recent advances in technology and establishment of standardized protocols for MEP reduces the variability associated with this procedure. The objective of this study is to evaluate the reliability and feasibility of MEP and SSEP in an international, multicenter trial so that mmEP can be further evaluated as a biomarker for disease progression. The rationale for this study is to explore the feasibility and reliability of MEP's and somatosensory evoked potentials (SSEP's) in a multicenter clinical trial for potential use as a biomarker that can predict clinical progression/improvement in international clinical trials evaluating remyelinating therapies.
Study Objectives and Endpoints:
Objective:
The primary objective of the study is to evaluate the feasibility and test-retest reliability of MEP's and (SSEP's) in a multicenter clinical trial in healthy subjects and subjects with MS.
Endpoints:
The primary reliability endpoint will be the intraclass correlation coefficient (ICC) of the following evoked potential parameters
Motor Evoked parameters that will be measured:
- MEP latency
- Central motor conduction time (CMCT) root latency methods
- MEP amplitude
- MEP amplitude to compound motor amplitude ratio (MEP-M ratio) for the right and left abductor digiti minimi (ADM) and the right and left tibialis anterior (TA)
- Somatosensory evoked potential parameters will include Evoked potential latencies for both upper and lower limbs bilaterally.
Study Design:
This multinational, multicenter study will be conducted in healthy adult volunteers and MS patients to establish the feasibility and reliability of mmEP's. A total of 40 subjects, 10 (5 healthy and 5 MS) from each of the 4 sites will be enrolled.
The study will consist of two visits, 1-30 days apart, during which subjects will be screened to confirm eligibility and will complete all specified study assessments.
Study Locations:
Canada, Germany, Switzerland and Italy, with 1 site in each country.
Number of Planned Subjects:
A minimum of 40 subjects are planned for this study. Subjects who withdraw from the study prior to completion of the second visit may be replaced at the discretion of the investigator.
Study Population:
This study will be conducted in subjects 25 to 58 years of age, inclusive, who are either healthy volunteers (HV) or have been diagnosed with clinically definite MS who have a detectable lesion by MEP or SSEP.
Study Groups:
Two groups, healthy volunteers and clinically definite MS will be included.
Duration of Study Participation:
Study duration for each subject will be two visits, the second visit schedule >24 hours-30 days from the first visit
Criteria for Evaluation:
Key Study Assessments:
Electrophysiological. MEP's and SSEPs will be measured in both upper and lower limbs bilaterally. All studies will be read locally and reviewed by a blinded reader at another center. The ICC of every measured evoked potential parameter will be determined on both the central and local reads.
- Conditions
- Multiple Sclerosis
- Being tested
- multimodal evoked potentials
- Keywords
- motor evoked potential, somatosensory evoked potentials, biomarker
- 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 potentialsOther
| Study group | Role | What they receive |
|---|---|---|
| healthy | healthy volunteers, 18 to 58 years old, with no neurological disease that could affect evoked potential responses
Intervention: multimodal evoked potentials Receives: Other: multimodal evoked potentials | |
| multiple sclerosis | All types of Multiple sclerosis patients:
* Aged 18 to 58 years old, inclusive, at the time of informed consent.
* 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. The MEP and SSEP responses do not need to be in the same limb
* Have no comorbid condition (ie neuropathy) that could affect testing.
Intervention: multimodal evoked potentials Receives: Other: multimodal evoked potentials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraclass correlation coefficient (ICC) of the multi modal evoked potential parameters in order to determine the validity of the compound measures
multi modal evoked potential will include:
- MEP latency (msec)
- Central motor conduction time (CMCT) using root latency methods (msec)
- MEP amplitude (mvolt) and MEP/CMAP amplitude ratio (%)
Measured: obtained between two assessments done more than 24 hrs but less than 1 month apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study startApr 2016
- Primary completionJan 2018
- Study completionJan 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.
- 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
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Neuro-Outaouais
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Francois Jacques, Clinique Neuro-Outaouais
- Investigators
- François Jacques, MD, Principal investigator, Clinique Neuro-Outaouais
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03047460
- Sponsor's protocol ID
- CNO-005
- Status last verified
- Mar 2019
- First submitted
- 7 Nov 2016
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: the data will pooled with 3 other centers to augment the power of the study
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Reliability of Multimodal Evoked Potentials in an International Multicenter Setting
- ClinicalTrials.gov ID
- NCT03047460
- Acronym / sponsor ID
- CNO-005
- Conditions
- Multiple Sclerosis
- Keywords
- motor evoked potential, somatosensory evoked potentials, biomarker
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Clinique Neuro-OutaouaisUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 9 Feb 2017 (estimated)
- 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.
Study Objectives and Endpoints:
Objective:
The primary objective of the study is to evaluate the feasibility and test-retest reliability of MEP's and (SSEP's) in a multicenter clinical trial in healthy subjects and subjects with MS.
Endpoints:
The primary reliability endpoint will be the intraclass correlation coefficient (ICC) of the following evoked potential parameters
Detailed description
The establishment of a biomarker(s) that can predict a clinical response to therapy over the course of a 1-2 year clinical trial is critical for the expeditious development of treatments for Multiple Sclerosis (MS). Identification of this biomarker would enable shorter and smaller clinical trials resulting in the faster development of much needed treatments for MS, specifically neuro-reparative therapies. The etiology of disease progression is conduction block, demyelination and axonal degeneration. Evoked potentials provide a direct assessment of the underlying etiologies of disease progression in MS. They are a functional assessment of multiple pathways, including visual, motor and sensory, evaluating the integrity of myelin and axons.
The variability of motor evoked potentials (MEP) measures has limited multimodal evoked potential (mmEP) use in international, multicenter clinical trials. MEP evaluation does significantly contribute to the predictive value of mmEP's. Recent advances in technology and establishment of standardized protocols for MEP reduces the variability associated with this procedure. The objective of this study is to evaluate the reliability and feasibility of MEP and SSEP in an international, multicenter trial so that mmEP can be further evaluated as a biomarker for disease progression. The rationale for this study is to explore the feasibility and reliability of MEP's and somatosensory evoked potentials (SSEP's) in a multicenter clinical trial for potential use as a biomarker that can predict clinical progression/improvement in international clinical trials evaluating remyelinating therapies.
Study Objectives and Endpoints:
Objective:
The primary objective of the study is to evaluate the feasibility and test-retest reliability of MEP's and (SSEP's) in a multicenter clinical trial in healthy subjects and subjects with MS.
Endpoints:
The primary reliability endpoint will be the intraclass correlation coefficient (ICC) of the following evoked potential parameters
Motor Evoked parameters that will be measured:
- MEP latency
- Central motor conduction time (CMCT) root latency methods
- MEP amplitude
- MEP amplitude to compound motor amplitude ratio (MEP-M ratio) for the right and left abductor digiti minimi (ADM) and the right and left tibialis anterior (TA)
- Somatosensory evoked potential parameters will include Evoked potential latencies for both upper and lower limbs bilaterally.
Study Design:
This multinational, multicenter study will be conducted in healthy adult volunteers and MS patients to establish the feasibility and reliability of mmEP's. A total of 40 subjects, 10 (5 healthy and 5 MS) from each of the 4 sites will be enrolled.
The study will consist of two visits, 1-30 days apart, during which subjects will be screened to confirm eligibility and will complete all specified study assessments.
Study Locations:
Canada, Germany, Switzerland and Italy, with 1 site in each country.
Number of Planned Subjects:
A minimum of 40 subjects are planned for this study. Subjects who withdraw from the study prior to completion of the second visit may be replaced at the discretion of the investigator.
Study Population:
This study will be conducted in subjects 25 to 58 years of age, inclusive, who are either healthy volunteers (HV) or have been diagnosed with clinically definite MS who have a detectable lesion by MEP or SSEP.
Study Groups:
Two groups, healthy volunteers and clinically definite MS will be included.
Duration of Study Participation:
Study duration for each subject will be two visits, the second visit schedule >24 hours-30 days from the first visit
Criteria for Evaluation:
Key Study Assessments:
Electrophysiological. MEP's and SSEPs will be measured in both upper and lower limbs bilaterally. All studies will be read locally and reviewed by a blinded reader at another center. The ICC of every measured evoked potential parameter will be determined on both the central and local reads.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy | – | Other: multimodal evoked potentialshealthy volunteers, 18 to 58 years old, with no neurological disease that could affect evoked potential responses Intervention: multimodal evoked potentials |
| multiple sclerosis | – | Other: multimodal evoked potentialsAll types of Multiple sclerosis patients: * Aged 18 to 58 years old, inclusive, at the time of informed consent. * 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. The MEP and SSEP responses do not need to be in the same limb * Have no comorbid condition (ie neuropathy) that could affect testing. Intervention: multimodal evoked potentials |
Who may qualify
- Ages
- 18 to 58 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy volunteers and MS patients aged 18 to 58 that have no other neurological comorbities that could affect evoked potential responses
Key inclusion criteria (10 listed)
- To be eligible to participate in this study, candidates must meet the following eligibility criteria at Screening, or at the time point specified in the individual eligibility criterion listed (HV cohort):
- To be eligible to be included in this cohort, candidates must meet the following additional eligibility criteria at Screening:
- 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.
- Aged 18 to 58 years old, inclusive, at the time of informed consent.
- Diagnosis of MS (all types) with an expanded disability status scale (EDSS) 0.0 to 6.5.
Key exclusion criteria (7 listed)
- Candidates will be excluded from study entry if any of the following exclusion criteria exist at screening or at any time during the study.
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 | Other | healthy, multiple sclerosis |
Primary outcome
Intraclass correlation coefficient (ICC) of the multi modal evoked potential parameters in order to determine the validity of the compound measures
Time frame: obtained between two assessments done more than 24 hrs but less than 1 month apart
multi modal evoked potential will include: * MEP latency (msec) * Central motor conduction time (CMCT) using root latency methods (msec) * MEP amplitude (mvolt) and MEP/CMAP amplitude ratio (%)
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 6 Mar 2019.
- Individual participant dataSharing planned: Yes. the data will pooled with 3 other centers to augment the power of the study
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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.
François Jacques, MD principal investigator
Clinique Neuro-Outaouais
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 Clinique Neuro-Outaouais at 1 site in Canada.
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 10 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 6 Mar 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 Canada. 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 the multi modal evoked potential parameters in order to determine the validity of the compound measures (time frame: obtained between two assessments done more than 24 hrs but less than 1 month apart). 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 6 Mar 2019.