NCT04604041

Investigation of Subclinical Markers of Multiple Sclerosis

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: University of Split, School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: —

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.

Detailed description

The following techniques will be applied: * Neurophysiological testing will be performed with navigated transcranial magnetic stimulation (nTMS) incorporating an individual MRI of each subject's brain performed on a 1,5 MRI scanner using a series of neuropsychological protocols. Mapping of the primary motor cortex for upper and lower extremity muscles with a recording of motor evoked potentials (MEP) will be performed. * Electromyoneurography (EMNG) assessment of lower and upper extremities for motor and sensory nerves; * Neuropsychological assessment will include the general questionnaire and battery of cognitive and psychological tests; * Immunoassays on blood samples include determination of different markers on monocytes and lymphocytes using flow cytometry, as well as determination of CD163 in serum samples using ELISA. * Clinical examinations include neurological, biochemical, neuroradiological, and neuropsychological testing.

Conditions

• Multiple Sclerosis
• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	1. 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.

Timeline

• Start date: 2020-11-23
• Primary completion: 2024-12-01
• Completion: 2028-12-31
• First posted: 2020-10-27
• Last updated: 2023-10-02

Locations

1 site across 1 country: Croatia