Motor Evoked Potentials With Modified Facilitation Technique (EP-F)

Motor Evoked Potentials With Modified Facilitation Technique: Normative Data and Reliability in Healthy Individuals and Comparison of Sensitivity and Specificity With Standard Technique in Patients With Multiple Sclerosis

Investigating the change in Test- Retest- reliability in healthy individuals when applying a modified easy to use facilitation technique compared to standard facilitation technique and analyzing sensitivity and specificity in patients with multiple sclerosis regarding detection of pathologic results

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Diagnostic test: MEP using standard facilitation technique; Diagnostic test: MEP using modified facilitation technique

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Dep. of Neurology and Clinical Neurophysiology , Hospital of the University of Basel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria for healthy individuals:

• Ability to understand the purpose and risks of the study, provide signed and dated informed consent
• Between 18 and 65 year of age
• No neurologic or psychiatric comorbidity requiring continous treatment
• No previous damage of central nervous System

Inclusion Criteria for patients:

• Ability to understand the purpose and risks of the study, provide signed and dated informed consent
• Between 18 and 65 year of age
• patients with inflammatory diseases of the central nervous system (CNS) or multiple sclerosis appointed for routine MEP diagnostic at the Department of Clinical Neurophysiology, University Hospital Basel

Exclusion Criteria:

• Contraindication for measuring of motoric evoked potentials (MEP): metal implants (pacemaker, stents); known epilepsy oder previous epileptic fit
• Known disease of the peripheral nervous system (polyneuropathy)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: healthy individuals and patients with multiple sclerosis; MEP in healthy individuals and patients with multiple sclerosis are measured using standard facilitation technique	Diagnostic test: MEP using standard facilitation technique; measuring of MEP using standard facilitation technique according to the Guidelines of International Federation of Clinical Neurophysiology
OTHER: patients with multiple sclerosis; MEP in patients with multiple sclerosis are measured using modified facilitation technique	Diagnostic test: MEP using standard facilitation technique; measuring of MEP using standard facilitation technique according to the Guidelines of International Federation of Clinical Neurophysiology; Diagnostic test: MEP using modified facilitation technique; measuring of MEP using modified facilitation technique (application of additional 8-12x magnetic stimuli for arms and legs)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Test- Re-Test reliability when using modified facilitation technique (compared to standard facilitation technique) in healthy individuals	Determination of mean intra-individual difference between measuring time 1 and measuring time 2 and calculation of standard deviation	measuring time 2 (75 minutes) maximal 1 month later than measuring time 1 (75 minutes)
comparison of sensitivity and specificity of modified facilitation technique and standard facilitation technique in patients with multiple sclerosis	Determination on the basis of the standard values (established in healthy individuals) in how many patients a pathological result with the modified facilitation technique and the standard facilitation technique is present. Using a a cross-tabulation, the sensitivity and specificity of the modified facilitating technique compared to the standard facilitation technique is measured	1 measuring time (90 minutes)

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Martin Hardmeier, PD Dr. med, University Hospital, Basel, Switzerland

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 20, 2017
• Primary Completion (ACTUAL): January 15, 2019
• Study Completion (ACTUAL): January 15, 2019

Study Registration Dates

• First Submitted: August 22, 2018
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (ACTUAL): August 24, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 5, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: facilitation technique; multimodal evoked potentials (mmEP) in multiple sclerosis; motor evoked potential (MEP) in multiple sclerosis
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: 2017-01893; me18Hardmeier

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No