Multiple Sclerosis (MS)IMAGINDEALinMSNCT05633875
Multimodal Imaging Signatures of the Biological Mechanisms Underlying Neurodegeneration in Multiple Sclerosis
An observational study of Multiple Sclerosis (MS), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis (MS)
- What is being tested?
- MRI
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 25 Apr 2023to 25 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Major subjects with Multiple Sclerosis will be included in this study
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CIC Neurosciences
Paris, 75013
STANKOFF Bruno
About this study
Official title: Multimodal Imaging Signatures of the Biological Mechanisms Underlying Neurodegeneration in Multiple Sclerosis: Long Term Predictive Value (IMAGIN-DEAL in MS)
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.
Read the detailed description
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
- Conditions
- Multiple Sclerosis (MS)
- Being tested
- MRI
- Keywords
- Multiple sclerosis (MS), MRI, RRMS, long term predictive value, PET-MRI
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIOther
Patients will undergo MRI without contrast agent
What is being measured
The primary outcome is the main question the study is designed to answer.
EDSS (Expanded Disability Status Scale) score
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
Measured: Inclusion
Secondary outcomes (11)
MSFC (Component of the Multiple Sclerosis Functional Score) score for neurological disability: 9-Hole Peg Test (9HPG)
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
Measured: Inclusion
SDMT(Symbol Digit Modalities Test) for speed processing
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
Measured: Inclusion
T25FW (Timed 25 Foot Walk test)
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
Measured: Inclusion
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
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)
Measured: Inclusion
10/36 Spatial Recall tests
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
Measured: Inclusion
RL/RI-16 memory test
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
Measured: Inclusion
Backward and forward verbal digit span test
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
Measured: Inclusion
Stroop test
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
Measured: Inclusion
Deno 80 test
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
Measured: Inclusion
White matter lesion load on MRI
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)
Measured: Inclusion
Whole brain, white matter, deep grey matter and cortical atrophy on MRI
Progression between baseline (inclusion in a first study: FLUMATEP, INFLASEP or SHADOWTEP) and follow up (IMAGIN-DEAL in MS)
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start25 Apr 2023
- Primary completion25 Jun 2026 (estimated)
- Study completion25 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple Sclerosis (MS)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Stankoff, Pr, Principal investigator, Assistance Publique - Hôpitaux de ParisOlivier Colliot, Mr, Study director, ARAMIS team (ICM) - Hospital Pitié-Salpêtrière
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05633875
- Sponsor's protocol ID
- APHP220766
- Acronym
- IMAGINDEALinMS
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2022
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multimodal Imaging Signatures of the Biological Mechanisms Underlying Neurodegeneration in Multiple Sclerosis: Long Term Predictive Value (IMAGIN-DEAL in MS)
- ClinicalTrials.gov ID
- NCT05633875
- Acronym / sponsor ID
- IMAGINDEALinMS / APHP220766
- Conditions
- Multiple Sclerosis (MS)
- Keywords
- Multiple sclerosis (MS), MRI, RRMS, long term predictive value, PET-MRI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 25 Jun 2026 (estimated)
- Study completion
- 25 Jun 2026 (estimated)
- First posted
- 1 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major subjects with Multiple Sclerosis will be included in this study
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIPatients will undergo MRI without contrast agent | Other | – |
Primary outcome
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
11 secondary outcomes
MSFC (Component of the Multiple Sclerosis Functional Score) score for neurological disability: 9-Hole Peg Test (9HPG)
Time frame: Inclusion
SDMT(Symbol Digit Modalities Test) for speed processing
Time frame: Inclusion
T25FW (Timed 25 Foot Walk test)
Time frame: Inclusion
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
10/36 Spatial Recall tests
Time frame: Inclusion
RL/RI-16 memory test
Time frame: Inclusion
Backward and forward verbal digit span test
Time frame: Inclusion
Stroop test
Time frame: Inclusion
Deno 80 test
Time frame: Inclusion
White matter lesion load on MRI
Time frame: Inclusion
Whole brain, white matter, deep grey matter and cortical atrophy on MRI
Time frame: Inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bruno Stankoff, Pr principal investigator
Assistance Publique - Hôpitaux de Paris
Olivier Colliot, Mr study director
ARAMIS team (ICM) - Hospital Pitié-Salpêtrière
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis (MS), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bruno Stankoff, MD (1 42 16 24 32 ext. +33, bruno.stankoff@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EDSS (Expanded Disability Status Scale) score (time frame: Inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.