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

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ClinicalTrials.gov Identifier: NCT03646929
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : September 12, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief 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

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Diagnostic Test: MEP using standard facilitation technique Diagnostic Test: MEP using modified facilitation technique Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : December 20, 2017
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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)




Primary Outcome Measures :
  1. Change in Test- Re-Test reliability when using modified facilitation technique (compared to standard facilitation technique) in healthy individuals [ Time Frame: measuring time 2 (75 minutes) maximal 1 month later than measuring time 1 (75 minutes) ]
    Determination of mean intra-individual difference between measuring time 1 and measuring time 2 and calculation of standard deviation

  2. comparison of sensitivity and specificity of modified facilitation technique and standard facilitation technique in patients with multiple sclerosis [ Time Frame: 1 measuring time (90 minutes) ]
    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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646929


Contacts
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Contact: Martin Hardmeier, PD Dr. med +41 61 556 5435 martin.hardmeier@usb.ch
Contact: Julia Opiatka julia.opiatka@stud.unibas.ch

Locations
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Switzerland
Dep. of Neurology and Clinical Neurophysiology , Hospital of the University of Basel Recruiting
Basel, Switzerland, 4031
Contact: Peter Fuhr, Prof.         
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Principal Investigator: Martin Hardmeier, PD Dr. med University Hospital, Basel, Switzerland

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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT03646929     History of Changes
Other Study ID Numbers: 2017-01893; me18Hardmeier
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: September 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Basel, Switzerland:
facilitation technique
multimodal evoked potentials (mmEP) in multiple sclerosis
motor evoked potential (MEP) in multiple sclerosis

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases