Feasibility and Reliability of Multimodal Evoked Potentials

NCT ID: NCT03686826

Last Updated: 2019-01-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 40 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-09-06
• Study Completion Date: 2018-12-31

Brief 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).

Detailed 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.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

multiple sclerosis patients

Acquisition of MEP und SSEP

Intervention Type: PROCEDURE

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

healthy volunteers

Acquisition of MEP und SSEP

Intervention Type: PROCEDURE

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

Interventions

Acquisition of MEP und SSEP

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 58 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Basel, Switzerland

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Fuhr, Prof. Dr. MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Basel; Department of Neurology

Locations

Dep. of Neurology, Hospital of the University of Basel

Basel, , Switzerland

Countries

Switzerland

Other Identifiers

2016-01099; me16Fuhr2

Identifier Type: -

Identifier Source: org_study_id