Investigation of Subclinical Markers of Multiple Sclerosis (SUBCLIN-MS)

University of Split

Status: Enrolling

Conditions: Multiple Sclerosis; Relapsing Remitting Multiple Sclerosis

Treatments: Diagnostic Test: 1. Clinical testing; 2. Neurophysiological examination (TMS, EMNG); 3. Psychomotor examination; 4. Neuropsychological evaluation; 5. Flow cytometry; 6. ELISA

Study type: Observational

Funder types: Other

Identifiers

NCT04604041

500-03/20-01/06 (Other Identifier)

2181-147-01/06/M.S.-20-2. (Other Identifier)

2181-198-03-04-20-0028.../0005

003-08/20-03/0005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

50 participants in 3 patient groups

Relapsing-remmitting MS group treated with corticosteroids

Description:

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

Treatment:

Diagnostic Test: 1. Clinical testing; 2. Neurophysiological examination (TMS, EMNG); 3. Psychomotor examination; 4. Neuropsychological evaluation; 5. Flow cytometry; 6. ELISA

Relapsing-remmitting MS group treated with immunomodulation

Description:

1. Clinical testing 2. Neurophysiological examination (TMS, EMNG) 4. Neuropsychological evaluation 5. Flow cytometry

Treatment:

Diagnostic Test: 1. Clinical testing; 2. Neurophysiological examination (TMS, EMNG); 3. Psychomotor examination; 4. Neuropsychological evaluation; 5. Flow cytometry; 6. ELISA

Healthy control group

Description:

5. Flow cytometry

Treatment:

Diagnostic Test: 1. Clinical testing; 2. Neurophysiological examination (TMS, EMNG); 3. Psychomotor examination; 4. Neuropsychological evaluation; 5. Flow cytometry; 6. ELISA