Investigation of Subclinical Markers of Multiple Sclerosis
NCT ID: NCT04604041
Last Updated: 2023-10-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
50 participants
OBSERVATIONAL
2020-11-23
2028-12-31
Brief Summary
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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.
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Detailed Description
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* 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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Relapsing-remmitting MS group treated with corticosteroids
1. Clinical testing
2. Neurophysiological examination (TMS, EMNG)
3. Psychomotor examination
4. Neuropsychological evaluation
5. Flow cytometry
6. ELISA
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.
Relapsing-remmitting MS group treated with immunomodulation
1\. Clinical testing 2. Neurophysiological examination (TMS, EMNG) 4. Neuropsychological evaluation 5. Flow cytometry
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.
Healthy control group
5\. Flow cytometry
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Patients with new pregnancies (verbally confirmed)
* Patients with new head trauma
* Subjects unwilling to sign a consent or follow study procedures
18 Years
65 Years
ALL
No
Sponsors
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University Hospital of Split
OTHER
University of Split, School of Medicine
OTHER
Responsible Party
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Maja Rogić Vidaković
Research Associate Maja Rogić Vidaković
Principal Investigators
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Maja Rogić Vidaković, MSc, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Split, School of Medicine
Locations
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University of Split School of Medicine
Split, , Croatia
Countries
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Central Contacts
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Facility Contacts
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References
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Polman CH, Reingold SC, Banwell B, Clanet M, Cohen JA, Filippi M, Fujihara K, Havrdova E, Hutchinson M, Kappos L, Lublin FD, Montalban X, O'Connor P, Sandberg-Wollheim M, Thompson AJ, Waubant E, Weinshenker B, Wolinsky JS. Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria. Ann Neurol. 2011 Feb;69(2):292-302. doi: 10.1002/ana.22366.
Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology. 1983 Nov;33(11):1444-52. doi: 10.1212/wnl.33.11.1444.
Mamoei S, Hvid LG, Boye Jensen H, Zijdewind I, Stenager E, Dalgas U. Neurophysiological impairments in multiple sclerosis-Central and peripheral motor pathways. Acta Neurol Scand. 2020 Nov;142(5):401-417. doi: 10.1111/ane.13289. Epub 2020 Jun 23.
Gorgulu U, Ergun U, Ertugrul L. Peripheral nerve conductions in relapsing remitting multiple sclerosis (RRMS) patients. J Clin Neurosci. 2020 Apr;74:93-97. doi: 10.1016/j.jocn.2020.01.058. Epub 2020 Feb 3.
Gjelstrup MC, Stilund M, Petersen T, Moller HJ, Petersen EL, Christensen T. Subsets of activated monocytes and markers of inflammation in incipient and progressed multiple sclerosis. Immunol Cell Biol. 2018 Feb;96(2):160-174. doi: 10.1111/imcb.1025. Epub 2017 Dec 11.
Howard LM, Miga AJ, Vanderlugt CL, Dal Canto MC, Laman JD, Noelle RJ, Miller SD. Mechanisms of immunotherapeutic intervention by anti-CD40L (CD154) antibody in an animal model of multiple sclerosis. J Clin Invest. 1999 Jan;103(2):281-90. doi: 10.1172/JCI5388.
Kawarabayashi R, Motoyama K, Nakamura M, Yamazaki Y, Morioka T, Mori K, Fukumoto S, Imanishi Y, Shioi A, Shoji T, Emoto M, Inaba M. The Association between Monocyte Surface CD163 and Insulin Resistance in Patients with Type 2 Diabetes. J Diabetes Res. 2017;2017:6549242. doi: 10.1155/2017/6549242. Epub 2017 Dec 28.
Wojcik CM, Beier M, Costello K, DeLuca J, Feinstein A, Goverover Y, Gudesblatt M, Jaworski M 3rd, Kalb R, Kostich L, LaRocca NG, Rodgers JD, Benedict RH; National MS Society Cognition Work Team. Computerized neuropsychological assessment devices in multiple sclerosis: A systematic review. Mult Scler. 2019 Dec;25(14):1848-1869. doi: 10.1177/1352458519879094. Epub 2019 Oct 22.
Thompson AJ, Banwell BL, Barkhof F, Carroll WM, Coetzee T, Comi G, Correale J, Fazekas F, Filippi M, Freedman MS, Fujihara K, Galetta SL, Hartung HP, Kappos L, Lublin FD, Marrie RA, Miller AE, Miller DH, Montalban X, Mowry EM, Sorensen PS, Tintore M, Traboulsee AL, Trojano M, Uitdehaag BMJ, Vukusic S, Waubant E, Weinshenker BG, Reingold SC, Cohen JA. Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria. Lancet Neurol. 2018 Feb;17(2):162-173. doi: 10.1016/S1474-4422(17)30470-2. Epub 2017 Dec 21.
Jerkovic A, Matijaca M, Prorokovic A, Sikic A, Kosta V, Curkovic Katic A, Dolic K, Duka Glavor K, Soda J, Dogas Z, Rogic Vidakovic M. Information Processing Speed Assessed with Letter Digit Substitution Test in Croatian Sample of Multiple Sclerosis Patients. Diagnostics (Basel). 2022 Jan 4;12(1):111. doi: 10.3390/diagnostics12010111.
Jerkovic A, Prorokovic A, Matijaca M, Vuko J, Poljicanin A, Mastelic A, Curkovic Katic A, Kosta V, Kustura L, Dolic K, Ethogas Z, Rogic Vidakovic M. Psychometric Properties of the HADS Measure of Anxiety and Depression Among Multiple Sclerosis Patients in Croatia. Front Psychol. 2021 Nov 30;12:794353. doi: 10.3389/fpsyg.2021.794353. eCollection 2021.
Rogic Vidakovic M, Simic N, Poljicanin A, Nikolic Ivanisevic M, Ana J, Dogas Z. Psychometric properties of the Croatian version of the depression, anxiety, and stress scale-21 and multiple sclerosis impact scale-29 in multiple sclerosis patients. Mult Scler Relat Disord. 2021 May;50:102850. doi: 10.1016/j.msard.2021.102850. Epub 2021 Feb 20.
Bralic A, Pavelin S, Pleic N, Soda J, Dolic K, Markotic A, Curkovic Katic A, Mastelic A, Rezic Muzinic N, Duranovic J, Kljajic Z, Stipica Safic I, Dogas Z, Rogic Vidakovic M. Correspondence of MRI and nTMS With EDSS in Multiple Sclerosis: Longitudinal Follow-Up Study. Ann Clin Transl Neurol. 2025 Jun;12(6):1240-1255. doi: 10.1002/acn3.70041. Epub 2025 Apr 17.
Other Identifiers
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003-08/20-03/0005
Identifier Type: OTHER
Identifier Source: secondary_id
2181-147-01/06/M.S.-20-2.
Identifier Type: OTHER
Identifier Source: secondary_id
500-03/20-01/06
Identifier Type: OTHER
Identifier Source: secondary_id
2181-198-03-04-20-0028.../0005
Identifier Type: -
Identifier Source: org_study_id
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