NCT06827834

Brief Summary

Multiple sclerosis (MS) is the most common demyelinating disease of the central nervous system and the most common cause of non-traumatic neurological disability in young adults. Magnetic resonance imaging (MRI) is the most important paraclinical investigation used in the diagnosis and monitoring of the disease. In the past years, spinal cord MRI has improved significantly and has become an important part of the diagnostic workup for MS. Presently, follow-up imaging of the spinal cord is only performed when spinal cord related symptoms occur. However, there is increasing evidence that asymptomatic spinal cord lesions can occur, independently of brain disease activity. Despite these cord lesions being asymptomatic, they impact disability accrual in the long term. Although this might be an imaging marker for monitoring and treatment, it is not yet applied in the clinical setting. The investigators will prospectively collect spinal cord MRI data (in addition to routine brain MRI), and blood-based biomarkers (plus cerebral spinal fluid markers, if available), in recently diagnosed MS patients, to address the following research questions:

  • What is the incidence of asymptomatic spinal cord lesions in patients commencing DMT?
  • And in the absence of radiological progression on brain imaging, how frequently do asymptomatic spinal cord lesions occur? In other words, how often is disease activity solely proven by spinal cord MRI and what is the number-needed-to-scan?
  • A secondary objective is to investigate which patients are predisposed to developing new spinal cord lesions during follow-up in the early stages of the disease. For this question, factors such as cerebrospinal fluid (CSF) profiles, B-cell composition in blood, soluble blood markers, and clinical features will be focused on.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
155

participants targeted

Target at P50-P75 for all trials

Timeline
25mo left

Started Aug 2024

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress47%
Aug 2024Jun 2028

Study Start

First participant enrolled

August 6, 2024

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 27, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 14, 2025

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Last Updated

February 14, 2025

Status Verified

January 1, 2025

Enrollment Period

3.8 years

First QC Date

January 27, 2025

Last Update Submit

February 10, 2025

Conditions

Multiple Sclerosis

Keywords

spinal cordmribiomarkersmultiple sclerosis

Outcome Measures

Primary Outcomes (1)

  • Spinal cord lesion count

    27 months

Secondary Outcomes (7)

  • Brain MRI acitivity

    27 months

  • Expanded disability status scale (EDSS)

    27 months

  • Timed 25 foot walk test

    27 months

  • Nine hole peg test

    27 months

  • No evidence of disease activity

    27 months

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population of treatment-naïve relapsing-remitting MS patients, early in the disease course (within 5 years of first clinical event) between 18 - 65 years old, where a first DMT is initiated.

You may qualify if:

  • Patients between 18 and 65 years old
  • Patients diagnosed with relapsing-remitting MS (≤5 years of first clinical event)
  • Treatment-naïve patients starting (currently in the Netherlands approved) DMT

You may not qualify if:

  • Patients who presented first clinical event more than five years ago
  • Patients who have already started DMT
  • Patients who are incapable of giving informed consent
  • Patients who are unable to undergo local MRI scan, due to for instance
  • Physical problems, for instance due to size/obesity (not fitting in regular MRI scanner), not being able to lie flat for extended periods of time (e.g. due to pain, shortness of breath)
  • Due to claustrophobia
  • Patients who have contraindications for MRI scan, for instance
  • Due to MRI-unsafe or non-compatible implanted material/devices, such as pacemakers or ocular metal splinters

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Rijnstate

Arnhem, Gelderland, 6815AD, Netherlands

NOT YET RECRUITING

Zuyderland Medisch Centrum

Geleen, Limburg, 6162BG, Netherlands

RECRUITING

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, North Brabant, 5223GZ, Netherlands

NOT YET RECRUITING

Albert Schweitzer ziekenhuis

Dordrecht, South Holland, 3318AT, Netherlands

RECRUITING

Erasmus MC

Rotterdam, South Holland, 3015GD, Netherlands

NOT YET RECRUITING

Related Publications (5)

  • Di Sabatino E, Gaetani L, Sperandei S, Fiacca A, Guercini G, Parnetti L, Di Filippo M. The no evidence of disease activity (NEDA) concept in MS: impact of spinal cord MRI. J Neurol. 2022 Jun;269(6):3129-3135. doi: 10.1007/s00415-021-10901-2. Epub 2021 Nov 24.

    PMID: 34820734BACKGROUND

  • Kreiter D, Spee R, Merry A, Hupperts R, Gerlach O. Effect of disease-modifying treatment on spinal cord lesion formation in multiple sclerosis: A retrospective observational study. Mult Scler Relat Disord. 2023 Nov;79:104994. doi: 10.1016/j.msard.2023.104994. Epub 2023 Sep 4.

    PMID: 37683557BACKGROUND

  • Brownlee WJ, Altmann DR, Alves Da Mota P, Swanton JK, Miszkiel KA, Wheeler-Kingshott CG, Ciccarelli O, Miller DH. Association of asymptomatic spinal cord lesions and atrophy with disability 5 years after a clinically isolated syndrome. Mult Scler. 2017 Apr;23(5):665-674. doi: 10.1177/1352458516663034. Epub 2016 Aug 6.

    PMID: 27481210BACKGROUND

  • Granella F, Tsantes E, Graziuso S, Bazzurri V, Crisi G, Curti E. Spinal cord lesions are frequently asymptomatic in relapsing-remitting multiple sclerosis: a retrospective MRI survey. J Neurol. 2019 Dec;266(12):3031-3037. doi: 10.1007/s00415-019-09526-3. Epub 2019 Sep 7.

    PMID: 31494713BACKGROUND

  • Zecca C, Disanto G, Sormani MP, Riccitelli GC, Cianfoni A, Del Grande F, Pravata E, Gobbi C. Relevance of asymptomatic spinal MRI lesions in patients with multiple sclerosis. Mult Scler. 2016 May;22(6):782-91. doi: 10.1177/1352458515599246. Epub 2015 Oct 12.

    PMID: 26459149BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Central Study Contacts

Demmie Bouweriks, MD

CONTACT

+31884597603d.bouweriks@zuyderland.nl

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 27, 2025

First Posted

February 14, 2025

Study Start

August 6, 2024

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2028

Last Updated

February 14, 2025

Record last verified: 2025-01

Locations

NL(5)