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NCT Number: NCT05491031

MRI Biomarkers Predictive of Disability Progression in Patients With Multiple Sclerosis

The transition from relapsing-remitting multiple sclerosis to secondarily progressive multiple sclerosis (SPMS) is difficult to identify. Typically, SPMS is diagnosed retrospectively, with a significant delay, on the basis of a clinical history of progressive worsening, independent of relapses. Thus, SPMS is often associated with a considerable period of diagnostic uncertainty.

The use of ultra-high field imaging can shed light on the mechanisms of disability progression thanks to its better spatial resolution and advanced imaging techniques.

The new morphological imaging techniques make it possible to visualize chronic inflammatory lesions and to evaluate their evolution. It also allows for the precise measurement of brain atrophy, a reference in the evaluation of neurodegeneration.

Metabolic imaging via proton spectroscopy allows the analysis of several promising cerebral metabolites that can provide information on cellular energy metabolism, mitochondrial function, or oxidative stress, and can help identify tissues at risk of neurodegeneration. Sodium imaging can provide information on axonal energy metabolism before the occurrence of stable and irreversible axonal damage. This technique is promising as an early marker of neurodegeneration.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PoitiersUH

Poitiers, 86000, France

Location status: Recruiting

Location contact

Amélie Dos Santos

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥ 18 years,
  • Duration of disease ≤ 25 years,
  • Irreversible disability ≤ 7 (permanent wheelchair use) on the EDSS scale

Exclusion criteria

  • Other progressive neurological disease,
  • Isolated radiologic syndrome (RIS),
  • Severe psychiatric pathology not in balance,
  • Change in dosage, discontinuation or initiation of a psychotropic treatment within the last month,
  • Change in background MS treatment for less than 3 months,
  • A course of corticosteroids (oral or intravenous) for less than one month,
  • Patient with a contraindication to MRI: pregnancy, metallic ocular foreign body (accidental splinters or others), pacemaker, implantable defibrillator, neurostimulator not compatible with MRI 7.0 T, cochlear implants and in general any electronic medical equipment implanted in an irremovable way: metallic cardiac valve, vascular clips (formerly implanted on cranial aneurysm), metallic prosthesis...),
  • Illiterate and non-French speaking patient: patient who is partially or completely unable to read and write French.
  • Patient benefiting from reinforced protection, i.e. minor, subject deprived of liberty by a judicial or administrative decision, subject staying in a health or social establishment, adult under legal protection and finally patient in emergency situation,
  • Pregnant or breastfeeding women, women of childbearing age who do not have effective contraception (hormonal/mechanical: per os, injectable, transcutaneous, implantable, intrauterine device, or surgical: tubal ligation, hysterectomy, total oophorectomy)

Treatment and study plan

Magnetic Resonance Spectroscopy

Other

Investigation of the association, in patients with multiple sclerosis, between MRI biomarker data at inclusion and progression of physical disability during follow-up (6, 12, 18 and 24 months) assessed by a composite endpoint EDSS plus (EDSS, 9HPT, T25FW)

Primary outcomes

  1. Identify imaging biomarkers at inclusion predictive of disability progression.

    Time frame: up to 24 months

    Determine the correlation between biomarkers concentrations (in mmol/L) with physical disability at inclusion and during follow-up (6, 12, 18 and 24 months) in patients with multiple sclerosis.

    Physical disability is assessed by an Expanded Disability Status Scale plus (EDSS-plus). EDSS-Plus defined as progression on ⩾1 of 3 components (T25FW, 9HPT, EDSS). EDSS score is ordinal rating system ranging from 0 (normal neurological status) to 10 (death), Timed 25-Foot Walk test (T25FW) (second) and 9-Hole Peg Test (9HPT) based on the time for patient to take the 9 pegs and place them in the holes (second).

Secondary outcomes

  1. Determine the correlation between brain MRI and the concentration of imaging biomarkers (mmols) at 6, 12, 18 and 24 months.

    Time frame: up to 24 months

  2. Develop realistic mathematical models of disease progression associated with clinical assessment of disability through dynamics, by the EDSS-plus score (EDSS scale from 0 to 10, T25FW in seconds, 9HPT in seconds).

    Time frame: up to 24 months

    Mathematical models of disease progression using the concentration of biomarkers (in mmol) associated with clinical evaluation of disability (EDSS-plus) over a dynamic period.

  3. Develop an artificial intelligence algorithm to identify predictive markers for disability. The artificial intelligence algorithm utilizes patients' clinical (EDSSS-Plus Scale) and radiological (brain MRI) characteristics.

    Time frame: up to 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Amelie Dos Santos, Dr

CONTACT

[email protected]

+33.5.49.44.44.46

Sponsors and collaborators

Lead sponsor

Poitiers University Hospital

Other

Registry information

Official study title

Evaluation of MRI Biomarkers Predictive of Disability Progression in Patients With Multiple Sclerosis

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Aug 8, 2022
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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