NCT03646929

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Dec 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2019

Completed
Last Updated

May 5, 2021

Status Verified

May 1, 2021

Enrollment Period

1.1 years

First QC Date

August 22, 2018

Last Update Submit

May 4, 2021

Conditions

Multiple Sclerosis

Keywords

facilitation techniquemultimodal evoked potentials (mmEP) in multiple sclerosismotor evoked potential (MEP) in multiple sclerosis

Outcome Measures

Primary Outcomes (2)

  • 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)

Study Arms (2)

healthy individuals and patients with multiple sclerosis

OTHER

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

Diagnostic Test: MEP using standard facilitation technique

patients with multiple sclerosis

OTHER

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

Diagnostic Test: MEP using standard facilitation techniqueDiagnostic Test: MEP using modified facilitation technique

Interventions

MEP using standard facilitation techniqueDIAGNOSTIC_TEST

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

healthy individuals and patients with multiple sclerosispatients with multiple sclerosis
MEP using modified facilitation techniqueDIAGNOSTIC_TEST

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

patients with multiple sclerosis

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Multiple SclerosisMicrocephaly, microphthalmia, ectrodactyly of lower limbs, and prognathism

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Martin Hardmeier, PD Dr. med

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2018

First Posted

August 24, 2018

Study Start

December 20, 2017

Primary Completion

January 15, 2019

Study Completion

January 15, 2019

Last Updated

May 5, 2021

Record last verified: 2021-05

Locations

CH(1)