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NCT Number: NCT05633875

Multimodal Imaging Signatures of the Biological Mechanisms Underlying Neurodegeneration in Multiple Sclerosis

Multiple sclerosis (MS) is a chronic disease of the central nervous system characterised by multi-focal inflammatory and demyelinating lesions disseminated in the brain and in the spinal cord. Impressive advancements in the treatment of the autoimmune component of the disease have been achieved during the last decades, leading to a drastic reduction of white matter lesion accumulation and relapse rate along the disease course. However, the development of treatments effective for preventing or delaying the neurodegenerative component of the disease, that underly disability accrual and progression of the disease, remains a major challenge. The development of novel therapeutic strategies for neuroprotection that target all patients with MS is a priority objective for research in the next years. The critical steps towards identifying treatments that prevent neuro-axonal damage include a deep understanding of the mechanisms underlying neurodegeneration and the development of reliable biomarkers for assessing the efficacy of emerging drugs and for accelerating their translation to clinical use.

The team of Prof. Stankoff has pioneered an innovative imaging approach combining positron emission tomography and MRI, and succeeded in generating individual maps or key biological processes such as endogenous remyelination, neuroinflammation, or early damage preceding lesion formation. Using these approaches, it has been shown that these mechanisms were influencing disability worsening over the disease course, but the investigators still lack long term longitudinal studies for the validation of these advanced imaging metrics as prognosis markers. Recently, preliminary results have also suggested that a multimodal combination of advanced MRI sequences may have the potential to reproduce some PET results.

In this project the investigators propose to unravel the predictive value of individual maps of tremyelination, neuroinflammation, and early tissue damage, on long term disability worsening and to develop a novel imaging approach that aims to capture remyelination of lesions, ongoing inflammation invisible on T1 and T2 MRI sequences (subacute/chronic active lesions) and to predict short-term future disease activity (identify prelesional areas), from a single multimodal MRI acquisition in patients with MS.

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Key information

Conditions

Multiple Sclerosis (MS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CIC Neurosciences

Paris, 75013, France

Location status: Recruiting

Location contact

STANKOFF Bruno

CONTACT

About this study

MS patient already included in previous studies using MRI and/or PET-MR (INFLASEP (NCT02305264), FLUMATEP (NCT01651520) or SHADOWTEP) will be proposed a long-term follow up study.

Participants will undergo :

  • a full neurological examination including EDSS
  • medical history and comorbidities (including smoking)
  • concomitant and MS treatments
  • neuropsychological testing
  • Blood sample for serum biobanking
  • multimodal MRI

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Multiple Sclerosis Patient already enrolled in one of those 3 protocols since 8 years or more: INFLASEP, FLUMATEP 1-2 or SHADOWTEP
  • Adult patient
  • Affiliation to a social security scheme or beneficiary of such a scheme (Except "Aide Médicale d'Etat")
  • Consent obtained

Exclusion criteria

  • Any reasons, which does not allow to perform MRI, including claustrophobia, the implant of a pace maker or the presence of an intra-ocular foreign body (a contra- indication questionnaire will be filled in beforehand)
  • Pregnancy, breast-feeding, lack of efficient contraception
  • Current symptoms of severe or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary or cardiac disease, or any other chronic neurological diseases
  • Unwillingness to be informed in case of abnormal MRI (with a significant medical anomaly)
  • Enrolment in another interventional study protocol for the duration of his or her participation without physician's agreement
  • Patient under legal protection

Treatment and study plan

MRI

Other

Patients will undergo MRI without contrast agent

Primary outcomes

  1. EDSS (Expanded Disability Status Scale) score

    Time frame: Inclusion

    predictive value of imaging signatures (chronic active lesions, remyelination and prelesion areas) on the progression of neurological disability between the first inclusion in FLUMATEP, INFLASEP or SHADOWTEP study, and the inclusion in the current study. Scale: min=0 ;max=10

Secondary outcomes

  1. MSFC (Component of the Multiple Sclerosis Functional Score) score for neurological disability: 9-Hole Peg Test (9HPG)

    Time frame: Inclusion

    predictive value of imaging signatures (chronic active lesions, remyelination and prelesion areas) on the progression between baseline (inclusion in a first study: FLUMATEP, INFLASEP or SHADOWTEP) and follow up (IMAGIN-DEAL in MS). Scale: min=0 ;max=300

  2. SDMT(Symbol Digit Modalities Test) for speed processing

    Time frame: Inclusion

    predictive value of imaging signatures (chronic active lesions, remyelination and prelesion areas) on the progression between baseline (inclusion in a first study: FLUMATEP, INFLASEP or SHADOWTEP) and follow up (IMAGIN-DEAL in MS). Scale: min=0 ;max=110

  3. T25FW (Timed 25 Foot Walk test)

    Time frame: Inclusion

    predictive value of imaging signatures (chronic active lesions, remyelination and prelesion areas) on the progression between baseline (inclusion in a first study: FLUMATEP, INFLASEP or SHADOWTEP) and follow up (IMAGIN-DEAL in MS). Scale: min=0 ;max=180

  4. MSFC (component of the Multiple Sclerosis Functional Score) score for neurological disability: PASAT (Paced Auditory Serial Addition Test) 3 sec for speed processing. Scale: min=0 ;max=60

    Time frame: Inclusion

    predictive value of imaging signatures (chronic active lesions, remyelination and prelesion areas) on the progression between baseline (inclusion in a first study: FLUMATEP, INFLASEP or SHADOWTEP) and follow up (IMAGIN-DEAL in MS)

  5. 10/36 Spatial Recall tests

    Time frame: Inclusion

    predictive value of imaging signatures (chronic active lesions, remyelination and prelesion areas) on the progression between baseline (inclusion in a first study: FLUMATEP, INFLASEP or SHADOWTEP) and follow up (IMAGIN-DEAL in MS). Scale: min=0 ;max=30

  6. RL/RI-16 memory test

    Time frame: Inclusion

    predictive value of imaging signatures (chronic active lesions, remyelination and prelesion areas) on the progression between baseline (inclusion in a first study: FLUMATEP, INFLASEP or SHADOWTEP) and follow up (IMAGIN-DEAL in MS). Scale: min=0 ;max=100

  7. Backward and forward verbal digit span test

    Time frame: Inclusion

    predictive value of imaging signatures (chronic active lesions, remyelination and prelesion areas) on the progression between baseline (inclusion in a first study: FLUMATEP, INFLASEP or SHADOWTEP) and follow up (IMAGIN-DEAL in MS). Scale: min=0 ;max=48

  8. Stroop test

    Time frame: Inclusion

    predictive value of imaging signatures (chronic active lesions, remyelination and prelesion areas) on the progression between baseline (inclusion in a first study: FLUMATEP, INFLASEP or SHADOWTEP) and follow up (IMAGIN-DEAL in MS). Scale: min=0 ;max=100

  9. Deno 80 test

    Time frame: Inclusion

    predictive value of imaging signatures (chronic active lesions, remyelination and prelesion areas) on the progression between baseline (inclusion in a first study: FLUMATEP, INFLASEP or SHADOWTEP) and follow up (IMAGIN-DEAL in MS). Scale: min=0 ;max=80

  10. White matter lesion load on MRI

    Time frame: Inclusion

    predictive value of imaging signatures (chronic active lesions, remyelination and prelesion areas) on the progression between baseline (inclusion in a first study: FLUMATEP, INFLASEP or SHADOWTEP) and follow up (IMAGIN-DEAL in MS)

  11. Whole brain, white matter, deep grey matter and cortical atrophy on MRI

    Time frame: Inclusion

    Progression between baseline (inclusion in a first study: FLUMATEP, INFLASEP or SHADOWTEP) and follow up (IMAGIN-DEAL in MS)

Study contacts

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

Bruno Stankoff, MD

CONTACT

[email protected]

1 42 16 24 32 ext. +33

Fredy Pene, Mr

CONTACT

[email protected]

1 49 28 20 00 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Multimodal Imaging Signatures of the Biological Mechanisms Underlying Neurodegeneration in Multiple Sclerosis: Long Term Predictive Value (IMAGIN-DEAL in MS)

Acronym: IMAGINDEALinMS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Dec 1, 2022
Registry last updated
Dec 9, 2025

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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