Feasibility and Reliability of Multimodal Evoked Potentials in an International Multicenter Setting

March 4, 2019 updated by: Dr. Francois Jacques, Clinique Neuro-Outaouais

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Gatineau, Quebec, Canada, J9J 0A5
        • Clinique Neuro-Outaouais

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 58 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers and MS patients aged 18 to 58 that have no other neurological comorbities that could affect evoked potential responses

Description

Inclusion Criteria:

  • 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):

    1. 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.
    2. Aged 18 to 58 years old, inclusive, at the time of informed consent.
    3. Have no significant health issues, ie neuropathy or other demyelinating disorder that can affect testing.

Inclusion Criteria (MS Cohort)

To be eligible to be included in this cohort, candidates must meet the following additional eligibility criteria at Screening:

  1. 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.
  2. Aged 18 to 58 years old, inclusive, at the time of informed consent.
  3. Diagnosis of MS (all types) with an expanded disability status scale (EDSS) 0.0 to 6.5.
  4. 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
  5. Have no comorbid condition (ie neuropathy) that could affect testing.

Exclusion Criteria:

  • Candidates will be excluded from study entry if any of the following exclusion criteria exist at screening or at any time during the study.

    1. Inability to comply with study requirements.
    2. Unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment.
    3. 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).
    4. MS relapse within 3 months of either sessions.
    5. Initiation of treatment or dose adjustment within 1 month of either sessions with Fampyra, Tegretol, Baclofen, Zanaflex
    6. Febrile illness within 3 days of either sessions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
healthy

healthy volunteers, 18 to 58 years old, with no neurological disease that could affect evoked potential responses

Intervention: multimodal evoked potentials
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
Other: multimodal evoked potentials

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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 (%)
obtained between two assessments done more than 24 hrs but less than 1 month apart

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clinique Neuro-Outaouais

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2017

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 9, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 6, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 4, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CNO-005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

the data will pooled with 3 other centers to augment the power of the study

IPD Sharing Time Frame

for the duration of the study and completion of the analyses

IPD Sharing Access Criteria

all PI's at each center will have access to the data

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)
  • Analytic Code

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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