Evaluation of Clinical, Morphologic and Biochemical Markers in Multiple Sclerosis

Recruiting

• Conditions: Multiple Sclerosis

• Registration Number: NCT04892134
• Lead Sponsor: Medical University of Graz

Brief Summary

By combining clinical, morphological and biochemical markers a better understanding of the formation and progression of multiple sclerosis (MS) should be obtained

Detailed Description

The current study aims to comprehensively investigate the individual clinical, morphological and biochemical aspects of MS in order to elucidate underlying mechanisms leading to disease progression. This shall ultimately serve to identify imaging and biochemical markers, which may support clinical management of persons with MS (pwMS). The following markers will be assessed: demographics (age, sex), clinical (EDSS at baseline, disease duration); neuropsychological (SDMT (Symbol Digit Modalities Test) score); MRI (Magnetic Resonance Imaging) (lesion load, atrophy); Biochemical markers analyzed in cerebrospinal fluid (CSF), blood, DNA, RNA, peripheral blood mononuclear cells (PBMCs)

Study Timeline

• Study Start: 2019-10-03
• Study First Submitted: 2021-05-04
• Study First Submitted QC: 2021-05-18
• Study First Posted: 2021-05-19
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-18
• Last Update Posted: 2023-10-19
• Primary Completion: 2024-10-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Patients with suspected or proven multiple sclerosis
• The participants are patients who are in inpatient or outpatient care of the Department of Neurology at the Medical University of Graz, Austria

Exclusion Criteria

• Excluded from the examinations are all patients for whom an MRI examination is impossible or problematic

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prediction of EDSS ( Expanded Disability Status Scale) progression by combined markers of the disease	a maximum of 4 years	EDSS score

Secondary Outcome Measures

Name	Time	Method
Prediction of clinical relapses	a maximum of 4 years	Prediction of clinical relapses
Conversion from CIS (Clinically Isolated Syndrome) to MS (Multiple Sclerosis) defined by MRI and clinical criteria	a maximum of 4 years	Conversion from CIS to MS defined by MRI and clinical criteria
Time of transition to progressive form of MS	a maximum of 4 years	Time of transition to progressive form of MS
Neuropsychological progression (decrease in SDMT performance)	a maximum of 4 years	Neuropsychological progression (decrease in SDMT performance)
Increase in morphological damage (lesion load, atrophy)	a maximum of 4 years	Increase in morphological damage (lesion load, atrophy)

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Styria, Austria