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

NCT03047460 | Completed

• 1 other identifier: CNO-005
• Study Type: observational
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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. Endpoints: The primary reliability endpoint will be the intraclass correlation coefficient (ICC) of the following evoked potential parameters

Conditions

Multiple Sclerosis

Keywords

motor evoked potential; somatosensory evoked potentials; biomarker

Outcome Measures

Primary Outcomes (1)

• 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 (%)

  obtained between two assessments done more than 24 hrs but less than 1 month apart

Study Arms (2)

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

Interventions

multimodal evoked potentials OTHER

healthy; multiple sclerosis

Eligibility Criteria

• Age: 18 Years - 58 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinique Neuro-Outaouais: lead

Study Sites (1)

Clinique Neuro-Outaouais

Gatineau, Quebec, J9J 0A5, Canada

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• François Jacques, MD

  Clinique Neuro-Outaouais

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: neurologist

Study Record Dates

• First Submitted: November 7, 2016
• First Posted: February 9, 2017
• Study Start: April 1, 2016
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: March 6, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: for the duration of the study and completion of the analyses
• Access Criteria: all PI's at each center will have access to the data

Locations

CA (1)