Multiple SclerosisEP-FNCT03646929
Motor Evoked Potentials With Modified Facilitation Technique
A study testing MEP using standard facilitation technique and MEP using modified facilitation technique in people with Multiple Sclerosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- MEP using standard facilitation technique and MEP using modified facilitation technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Dec 2017to 15 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of Neurology and Clinical Neurophysiology , Hospital of the University of Basel
Basel, 4031
About this study
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
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
- Conditions
- Multiple Sclerosis
- Being tested
- MEP using standard facilitation technique, MEP using modified facilitation technique
- Keywords
- facilitation technique, multimodal evoked potentials (mmEP) in multiple sclerosis, motor evoked potential (MEP) in multiple sclerosis
- Medical subject headings
- Multiple Sclerosis, Microcephaly, microphthalmia, ectrodactyly of lower limbs, and prognathism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MEP using standard facilitation techniqueDiagnostic test
measuring of MEP using standard facilitation technique according to the Guidelines of International Federation of Clinical Neurophysiology
MEP using modified facilitation techniqueDiagnostic test
measuring of MEP using modified facilitation technique (application of additional 8-12x magnetic stimuli for arms and legs)
| Study group | Role | What they receive |
|---|---|---|
| healthy individuals and patients with multiple sclerosis | Other | MEP in healthy individuals and patients with multiple sclerosis are measured using standard facilitation technique Receives: Diagnostic Test: MEP using standard facilitation technique |
| patients with multiple sclerosis | Other | MEP in patients with multiple sclerosis are measured using modified facilitation technique Receives: Diagnostic Test: MEP using standard facilitation technique; Diagnostic Test: MEP using modified facilitation technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 measuring time (90 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start20 Dec 2017
- Primary completion15 Jan 2019
- Study completion15 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Martin Hardmeier, PD Dr. med, Principal investigator, University Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646929
- Sponsor's protocol ID
- 2017-01893; me18Hardmeier
- Other IDs
- 2017
- Acronym
- EP-F
- Status last verified
- May 2021
- First submitted
- 22 Aug 2018
- Last updated
- 5 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03646929
- Acronym / sponsor ID
- EP-F / 2017-01893; me18Hardmeier
- Conditions
- Multiple Sclerosis
- Keywords
- facilitation technique, multimodal evoked potentials (mmEP) in multiple sclerosis, motor evoked potential (MEP) in multiple sclerosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 15 Jan 2019 (actual)
- Study completion
- 15 Jan 2019 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| healthy individuals and patients with multiple sclerosis | Other | Diagnostic Test: MEP using standard facilitation techniqueMEP in healthy individuals and patients with multiple sclerosis are measured using standard facilitation technique |
| patients with multiple sclerosis | Other | Diagnostic Test: MEP using standard facilitation technique, Diagnostic Test: MEP using modified facilitation techniqueMEP in patients with multiple sclerosis are measured using modified facilitation technique |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MEP using standard facilitation techniquemeasuring of MEP using standard facilitation technique according to the Guidelines of International Federation of Clinical Neurophysiology | Diagnostic test | healthy individuals and patients with multiple sclerosis, patients with multiple sclerosis |
| MEP using modified facilitation techniquemeasuring of MEP using modified facilitation technique (application of additional 8-12x magnetic stimuli for arms and legs) | Diagnostic test | patients with multiple sclerosis |
Primary outcome
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Martin Hardmeier, PD Dr. med principal investigator
University Hospital, Basel, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MEP using standard facilitation technique and MEP using modified facilitation technique in people with Multiple Sclerosis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2021.