RecruitingNCT04604041

Investigation of Subclinical Markers of Multiple Sclerosis


Sponsor

University of Split, School of Medicine

Enrollment

50 participants

Start Date

Nov 23, 2020

Study Type

OBSERVATIONAL

Conditions

Summary

Transcranial magnetic stimulation (TMS) studies reported consistent and substantial impairments in the central nervous system (CNS) in multiple sclerosis (MS). Studies of peripheral nervous system (PNS) function comprising electromyoneurography (EMNG) reported impairments of the PNS in MS that were less pronounced and inconsistent. Neurophysiological studies are generally small and cross-sectional and with the poor grouping of MS patients according to MS type. The objective of the study is to investigate clinical, neurophysiological, and immunological markers in relapsing-remitting MS patients, and in patients with relapsing-remitting MS treated with immunomodulation. The results of the study may contribute to a better understanding of the pathophysiology of multiple sclerosis and can provide guidance in the diagnosis and treatment of patients with relapsing-remitting MS.


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria1

  • Subjects with a documented diagnosis of relapsing-remitting MS according to the Mc Donald criteria (2005) and with EDSS achievement of 0-3.5 according to the modified Kurtzke's EDSS (Expanded disability status scale) for the assessment of neurological function and incapacity of patients with multiple sclerosis

Exclusion Criteria4

  • Patients with metals in the body (e.g. pacemaker, dentures)
  • Patients with new pregnancies (verbally confirmed)
  • Patients with new head trauma
  • Subjects unwilling to sign a consent or follow study procedures

Interventions

DIAGNOSTIC_TEST1. Clinical testing; 2. Neurophysiological examination (TMS, EMNG); 3. Psychomotor examination; 4. Neuropsychological evaluation; 5. Flow cytometry; 6. ELISA

All groups will not have the same intervention. Interventions are listed and numbered for each group.


Locations(1)

University of Split School of Medicine

Split, Croatia

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NCT04604041


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