NCT03047460|Completed
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Sponsor study identifier
observational
14
1 country
1
Study Start
April 2016
Actual (reported)Primary Completion
January 2018
Actual (reported)Study Completion
January 2018
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2018
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2016
Actual (reported)November 7, 2016
Actual (reported)February 9, 2017
Actual (reported)January 2018
Actual (reported)January 2018
Actual (reported)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
healthy volunteers, 18 to 58 years old, with no neurological disease that could affect evoked potential responses Intervention: multimodal evoked potentials
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Healthy volunteers and MS patients aged 18 to 58 that have no other neurological comorbities that could affect evoked potential responses
Clinique Neuro-Outaouais
Gatineau, Quebec, J9J 0A5, Canada
François Jacques, MD
Clinique Neuro-Outaouais
14 participants (actual enrollment reported by the registry).
First Submitted
November 7, 2016
First Posted
February 9, 2017
Study Start
April 2016
Actual (reported)Adderall XR and Cognitive Impairment in MS
Contact the study team to confirm eligibility.
Primary Completion
January 2018
Actual (reported)Study Completion
January 2018
Actual (reported)Last Updated
March 6, 2019
Record last verified: 2019-03
the data will pooled with 3 other centers to augment the power of the study
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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