Motor Evoked Potentials as a Biomarker in Alemtuzumab Treated Multiple Sclerosis Patients

NCT02623946 | Completed

• 1 other identifier: CNO-004
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Study Design: Phase 4, pilot, single center, observational study. MEP's will be obtained twice, two weeks apart at baseline and every 6 months for 36 months (total of 14 sessions of MEP's) MEP's will include:

1. 1.Onset latencies and CMCT to bilateral abductor pollicis brevis and tibialis anterior muscles
2. 2.MEP amplitudes and the ratio of the central to peripherally obtained motor amplitudes (MEP-M ratio) to bilateral abductor pollicis brevis and tibialis anterior muscles Clinical measures (EDSS, MEP's, T25FWT, 6MWT, 9HPT) will be obtained at baseline and every 6 months for 36 months.

Conditions

Multiple Sclerosis

Keywords

motor evoked potentials

Outcome Measures

Primary Outcomes (1)

• intrapatient correlation coefficient of MEP's

  to measure within subject correlation a two-way fixed Intraclass Correlation (ICC) will be calculated for each of 10 participants across sessions measured two weeks apart. The ICC will provide an estimate of the variance of each individual's motor evoked potentials at each paired time point.

  obtained between two assessments done two weeks apart

Secondary Outcomes (2)

• Correlation coefficient between the changes from baseline MEP results and clinical measures (EDSS, 6MW, T25FWT, 9HPT)

  obtained every 6 months for 36 months

• Correlation between the change in the conduction index and the change in clincal measures

  obtained at baseline and every 6 months over 36 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with MacDonald criteria (2005) multiple sclerosis presently being treated with Alemtuzumab.

You may qualify if:

• Diagnosis of MS (McDonald criteria) and of age 18 and older;
• Subjects who meet the prescribing criteria for Alemtuzumab as per product monograph;
• An EDSS of 5.0 or less and a pyramidal system functional assessment score of 2 or greater;
• Subject who have received the first cycle of Alemtuzumab within the last 3 months.

You may not qualify if:

• Subjects who have begun using extended release Fampridine within 2 months of study baseline visit (Patient on a stable dose of extended release Fampridine for more than 2 months can enter the study);
• Subjects with MSSS (Multiple Sclerosis Severity Score) less than 4.0;
• Subject with other medical conditions that involve the CST's;
• Any other condition that would preclude them from undergoing the MEP's and/or MRI.

Sponsors & Collaborators

• Clinique Neuro-Outaouais: lead
• CogState Ltd.: collaborator

Study Sites (1)

Clinique Neuro-Outaouais

Gatineau, Quebec, J8Y 1W2, Canada

Location

Related Publications (1)

• Jacques FH, Apedaile BE, Danis I, Sikati-Foko V, Lecompte M, Fortin J. Motor Evoked Potential-A Pilot Study Looking at Reliability and Clinical Correlations in Multiple Sclerosis. J Clin Neurophysiol. 2024 May 1;41(4):357-364. doi: 10.1097/WNP.0000000000001003. Epub 2023 Mar 21.

  PMID: 36943437 DERIVED

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

• Francois H Jacques, MD

  Clinic Neuro-Outaouais; Director

  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 30, 2015
• First Posted: December 8, 2015
• Study Start: November 1, 2015
• Primary Completion: December 9, 2020
• Study Completion: February 1, 2021
• Last Updated: July 28, 2021

Record last verified: 2020-07

Locations

CA (1)