Diagnostic criteria for multiple sclerosis: 2010 revisions to the McDonald criteria.
Chris H Polman, Stephen C Reingold, Brenda Banwell...
https://pubmed.ncbi.nlm.nih.gov/21387374Actively Recruiting
Age: 18Years - 65Years
All Genders
ID04604041
Investigation of Subclinical Markers in Relapsing-Remitting Multiple Sclerosis Using Neurophysiological and Immunological Assessments
Led by University of Split, School of Medicine · Updated on 2023-10-02
50
Participants Needed
1
Research Sites
213 weeks
Total Duration
On this page
Sponsors
U
University of Split, School of Medicine
Lead Sponsor
U
University Hospital of Split
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating clinical, neurophysiological, and immunological markers in people with relapsing-remitting multiple sclerosis (MS). The study aims to better understand how MS affects the nervous system and how treatments like immunomodulation influence these markers. This research focuses on the central and peripheral nervous systems and seeks to improve diagnosis and care for relapsing-remitting MS patients. Participants will undergo various assessments including navigated transcranial magnetic stimulation (nTMS) combined with individual MRI brain scans, electromyoneurography (EMNG) tests, and neuropsychological evaluations. Blood samples will be analyzed using flow cytometry and ELISA to measure immune markers. Different study groups will receive specific assessments based on their treatment status, including corticosteroids or immunomodulation. During the study, participants will have neurological, biochemical, neuroradiological, psychomotor, and psychological testing. Researchers will measure changes in motor thresholds, nerve conduction, cognitive function, psychological state, and immune cell markers before and after treatment periods. The study will follow participants over time to monitor these measures and explore predictors of treatment response in relapsing-remitting MS.
CONDITIONS
Brief Title
Investigation of Subclinical Markers of Multiple Sclerosis
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- Diagnosis of relapsing-remitting multiple sclerosis according to Mc Donald criteria (2005)
- Expanded Disability Status Scale (EDSS) score between 0 and 3.5
- Adults aged 18 to 65 years
You will not qualify if you...
- Presence of metal implants such as pacemakers or dentures
- Current pregnancy or recent pregnancy confirmed verbally
- Recent head trauma
- Unwillingness to sign consent or follow study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Baseline and 5 weeks after steroid intake for some groups; baseline only for others
Participants undergo clinical, neurophysiological, psychomotor, neuropsychological, and immunological assessments to evaluate subclinical markers of multiple sclerosis.
2 visits (in-person) including baseline and 5-week follow-up assessments
Long-term Monitoring
Duration - Up to 6 months
Participants have follow-up assessments at 6 months to monitor changes in cognitive, psychological, and psychomotor functions after initial assessments.
1 follow-up visit (in-person) approximately 6 months after initial assessments
Trial Site Locations
Total: 1 location
1
University of Split School of Medicine
Split, Croatia, 21000
Actively Recruiting
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Research Team
M
Maja Rogić Vidaković, MSc, PhD
S
Sanda Pavelin, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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Published Research Related To This Trial
Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS).
J F Kurtzke
https://pubmed.ncbi.nlm.nih.gov/6685237Neurophysiological impairments in multiple sclerosis-Central and peripheral motor pathways.
Sepehr Mamoei, Lars G Hvid, Henrik Boye Jensen...
https://pubmed.ncbi.nlm.nih.gov/32474916Peripheral nerve conductions in relapsing remitting multiple sclerosis (RRMS) patients.
Ümit Görgülü, Ufuk Ergün, Levent Ertuğrul
https://pubmed.ncbi.nlm.nih.gov/32029369Subsets of activated monocytes and markers of inflammation in incipient and progressed multiple sclerosis.
Mikkel Carstensen Gjelstrup, Morten Stilund, Thor Petersen...
https://pubmed.ncbi.nlm.nih.gov/29363161Mechanisms of immunotherapeutic intervention by anti-CD40L (CD154) antibody in an animal model of multiple sclerosis.
L M Howard, A J Miga, C L Vanderlugt...
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Reina Kawarabayashi, Koka Motoyama, Miyuki Nakamura...
https://pubmed.ncbi.nlm.nih.gov/29445750Computerized neuropsychological assessment devices in multiple sclerosis: A systematic review.
Curtis M Wojcik, Meghan Beier, Kathleen Costello...
https://pubmed.ncbi.nlm.nih.gov/31637963Diagnosis of multiple sclerosis: 2017 revisions of the McDonald criteria.
Alan J Thompson, Brenda L Banwell, Frederik Barkhof...
https://pubmed.ncbi.nlm.nih.gov/29275977Information Processing Speed Assessed with Letter Digit Substitution Test in Croatian Sample of Multiple Sclerosis Patients.
Ana Jerković, Meri Matijaca, Ana Proroković...
https://pubmed.ncbi.nlm.nih.gov/35054278