Feasibility and Reliability of Multimodal Evoked Potentials

NCT03686826 | Completed

• 1 other identifier: 2016-01099; me16Fuhr2
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Multimodal Evoked potentials (mmEP) reflect disease course of multiple sclerosis (MS) and are potentially suited as a biomarker for disease progression. The acquisition of evoked potentials (EP) in this observatory trial is to evaluate the feasibility and test-retest reliability of motor and somato-sensory EP (MEP and SSEP) in an international multicenter setting in healthy subjects and subjects with multiple sclerosis (MS).

Conditions

Multiple Sclerosis

Keywords

evoked potentials (EP); motor evoked potentials (MEP); Somato-sensory evoked potentials (SSEP); multimodal evoked potentials (mmEP)

Outcome Measures

Primary Outcomes (1)

• intraclass correlation coefficient (ICC) of MEP and SSEP

  The primary analysis will be a descriptive statistical summary of MEP and SSEP results at the first session, the second session and overall. Intraclass correlation coefficients (ICC) will be calculated to assess the test-retest reliability between consecutive measurements and the interrater reliability between raters.

  time between Visit 1 (= Baseline = Day 0) and Visit 2 (= 1 day to 30 days after Visit 1)

Study Arms (2)

multiple sclerosis patients

Procedure: Acquisition of MEP und SSEP

healthy volunteers

Procedure: Acquisition of MEP und SSEP

Interventions

Acquisition of MEP und SSEP PROCEDURE

Acquisition of MEP und SSEP at two different time points within 1 to 30 days

healthy volunteers; multiple sclerosis patients

Eligibility Criteria

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

Study Population

Patients with MS will be recruited from the outpatient clinic at the University Hospital Basel as consecutive ongoing recruitment through project leader and Co-workers in daily clinical practice. Healthy subjects will be recruited by bulletin on notice-boards in the hospital

You may qualify if:

• 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.
• Have no significant health issues, ie neuropathy or other demyelinating disorder that can affect testing.
• 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
• 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 on visit 2. 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)
• Conditions interfering with magnetic stimulation (including but not limited to epilepsy, movable metal implants in the body such as pacemakers or stents)
• MS relapse within 3 months of either sessions
• Initiation of treatment or dose adjustment within 1 month of either sessions with 4-Aminopyridin, Carbamazepine, Baclofen, Tizianid
• Febrile illness within 3 days of either sessions.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Dep. of Neurology, Hospital of the University of Basel

Basel, 4031, Switzerland

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

• Peter Fuhr, Prof. Dr. MD

  University Hospital Basel; Department of Neurology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: September 27, 2018
• Study Start: September 6, 2016
• Primary Completion: September 15, 2017
• Study Completion: December 31, 2018
• Last Updated: January 23, 2019

Record last verified: 2019-01

Locations

CH (1)