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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03686826
Other study ID # 2016-01099; me16Fuhr2
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 6, 2016
Est. completion date December 31, 2018

Study information

Verified date January 2019
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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).


Description:

Multimodal EP (mmEP) is being developed as a predictive biomarker to determine the clinical response to therapy. MEP and SSEP contributes significantly to the predictive value of mmEP. The variability of MEP and SSEP has limited its use in multicenter clinical trials. Recent technological advances and standardization of procedures has decreased the variability. The objective of this study is to evaluate the reliability of MEP and SSEP and feasibility of performing MEP and SSEP in an international, multicenter setting. Establishment of the reliability and feasibility of MEP and SSEP will allow for further development of this predictive biomarker in future clinical trials.


Recruitment information / eligibility

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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Acquisition of MEP und SSEP
Acquisition of MEP und SSEP at two different time points within 1 to 30 days

Locations

Country Name City State
Switzerland Dep. of Neurology, Hospital of the University of Basel Basel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

Outcome

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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