Motor Evoked Potentials With Modified Facilitation Technique

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Diagnostic Test: MEP using standard facilitation technique
* Diagnostic Test: MEP using modified facilitation technique


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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motor evoked potential (MEP) in multiple sclerosis, facilitation technique, multimodal evoked potentials (mmEP) in multiple sclerosis