Multiple Sclerosis Clinical Trial
— EP-BOfficial title:
Feasibility and Reliability of Multimodal Evoked Potentials
Verified date | January 2019 |
Source | University Hospital, Basel, Switzerland |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Multimodal Evoked potentials (mmEP) reflect disease course of multiple sclerosis (MS) and are
potentially suited as a biomarker for disease progression.
The acquisition of evoked potentials (EP) in this observatory trial is to evaluate the
feasibility and test-retest reliability of motor and somato-sensory EP (MEP and SSEP) in an
international multicenter setting in healthy subjects and subjects with multiple sclerosis
(MS).
Status | Completed |
Enrollment | 40 |
Est. completion date | December 31, 2018 |
Est. primary completion date | September 15, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 58 Years |
Eligibility |
Inclusion Criteria (Healthy controls): - Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. - Have no significant health issues, ie neuropathy or other demyelinating disorder that can affect testing. Inclusion Criteria (Patients with MS): - Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations - Diagnosis of MS (all types) with an expanded disability status scale (EDSS) 0.0 to 6.5 - Have measurable responses on both MEP and SSEP in at least one upper and one lower limb on visit 2. The MEP and SSEP responses do not need to be in the same limb - Have no comorbid condition (ie neuropathy) that could affect testing Exclusion Criteria: - Inability to comply with study requirements - Unspecified reasons that, in the opinion of the Investigator, make the subject unsuitable for enrollment - Any diseases (e.g., non-MS demyelinating diseases), with the exception of diagnosis MS for the MS Cohort, that in the opinion of the Investigator, could influence evoked potential results (including but not limited to medullary trauma, morbid obesity, limb amputation, diabetes, other polyneuropathy) - Conditions interfering with magnetic stimulation (including but not limited to epilepsy, movable metal implants in the body such as pacemakers or stents) - MS relapse within 3 months of either sessions - Initiation of treatment or dose adjustment within 1 month of either sessions with 4-Aminopyridin, Carbamazepine, Baclofen, Tizianid - Febrile illness within 3 days of either sessions. |
Country | Name | City | State |
---|---|---|---|
Switzerland | Dep. of Neurology, Hospital of the University of Basel | Basel |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Basel, Switzerland |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | intraclass correlation coefficient (ICC) of MEP and SSEP | The primary analysis will be a descriptive statistical summary of MEP and SSEP results at the first session, the second session and overall. Intraclass correlation coefficients (ICC) will be calculated to assess the test-retest reliability between consecutive measurements and the interrater reliability between raters. | time between Visit 1 (= Baseline = Day 0) and Visit 2 (= 1 day to 30 days after Visit 1) |
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