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OpenTrials
Completed

NCT Number: NCT03646929

Motor Evoked Potentials With Modified Facilitation Technique

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

MEP using standard facilitation technique

Diagnostic Test

measuring of MEP using standard facilitation technique according to the Guidelines of International Federation of Clinical Neurophysiology

MEP using modified facilitation technique

Diagnostic Test

measuring of MEP using modified facilitation technique (application of additional 8-12x magnetic stimuli for arms and legs)

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study 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

Acronym: EP-F

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Aug 24, 2018
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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