Motor Evoked Potentials With Modified Facilitation Technique

Multiple Sclerosis Clinical Trial

— EP-F  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03646929
• Other study ID #: 2017-01893; me18Hardmeier
• Status: Completed
• Phase: N/A
• Start date: December 20, 2017
• Est. completion date: January 15, 2019

Study information

• Verified date: May 2021
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 81
• Est. completion date: January 15, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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)

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Diagnostic Test:
• MEP using standard facilitation technique
measuring of MEP using standard facilitation technique according to the Guidelines of International Federation of Clinical Neurophysiology
• MEP using modified facilitation technique
measuring of MEP using modified facilitation technique (application of additional 8-12x magnetic stimuli for arms and legs)

Locations

Country	Name	City	State
Switzerland	Dep. of Neurology and Clinical Neurophysiology , Hospital of the University of Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)