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

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Not Applicable

Locations

Switzerland

Study Type

Interventional

Intervention

MEP using standard facilitation technique

MEP using modified facilitation technique

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis focused on measuring facilitation technique, multimodal evoked potentials (mmEP) in multiple sclerosis, motor evoked potential (MEP) in multiple sclerosis

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

healthy individuals and patients with multiple sclerosis

patients with multiple sclerosis

Arm Description

MEP in healthy individuals and patients with multiple sclerosis are measured using standard facilitation technique

MEP in patients with multiple sclerosis are measured using modified facilitation technique

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

Full Information

NCT ID

NCT03646929

First Posted

August 22, 2018

Last Updated

May 4, 2021

Sponsor

University Hospital, Basel, Switzerland

1. Study Identification

Unique Protocol Identification Number

NCT03646929

Brief Title

Motor Evoked Potentials With Modified Facilitation Technique

Acronym

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

December 20, 2017 (Actual)

Primary Completion Date

January 15, 2019 (Actual)

Study Completion Date

January 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital, Basel, Switzerland

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

facilitation technique, multimodal evoked potentials (mmEP) in multiple sclerosis, motor evoked potential (MEP) in multiple sclerosis

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

81 (Actual)

8. Arms, Groups, and Interventions

Arm Title

healthy individuals and patients with multiple sclerosis

Arm Type

Other

Arm Description

MEP in healthy individuals and patients with multiple sclerosis are measured using standard facilitation technique

Arm Title

patients with multiple sclerosis

Arm Type

Other

Arm Description

MEP in patients with multiple sclerosis are measured using modified facilitation technique

Intervention Type

Diagnostic Test

Intervention Name(s)

MEP using standard facilitation technique

Intervention Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

MEP using modified facilitation technique

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Test- Re-Test reliability when using modified facilitation technique (compared to standard facilitation technique) in healthy individuals

Description

Determination of mean intra-individual difference between measuring time 1 and measuring time 2 and calculation of standard deviation

Time Frame

measuring time 2 (75 minutes) maximal 1 month later than measuring time 1 (75 minutes)

Title

comparison of sensitivity and specificity of modified facilitation technique and standard facilitation technique in patients with multiple sclerosis

Description

Time Frame

1 measuring time (90 minutes)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Martin Hardmeier, PD Dr. med

Organizational Affiliation

University Hospital, Basel, Switzerland

Official's Role

Principal Investigator

Facility Information:

Facility Name

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

City

Basel

ZIP/Postal Code

4031

Country

Switzerland

12. IPD Sharing Statement

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Motor Evoked Potentials With Modified Facilitation Technique

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