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Multiple SclerosisVHD cohortNCT05622643

OFSEP Very High Definition Cohort

An observational study of Multiple Sclerosis, run by EDMUS Foundation at 5 sites in France.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Multiple sclerosis (MS) is the most common acquired neurological disease leading to disability in young adults. MS often leads to the development of a physical and/or cognitive impairment that disables patients in their daily lives. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Multiple Sclerosis
What is being tested?
MRI
How many people
300 participants
Where
5 sitesFrance
Study dates
19 Jan 2023to 1 Dec 2027
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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: In order to ensure the inclusion of patients with different MS phenotypes representative of the general MS patients population in the VHD cohort, the investigators will aim to respect the inclusion percentages of at least 10% of patients with primary progressive MS and at least 15% of patients with secondary progressive MS.

Who may be able to join

  • The patient must be already included in the OFSEP High Definition cohort (NCT03603457).
  • The patient must have given his informed and signed consent for the inclusion in the VHD cohort.
  • The patient must be insured or beneficiary of a health insurance plan.
  • The healthy subject must be older than 18 years
  • The healthy subject must have given his informed and signed consent for the inclusion in the VHD cohort.
  • The healthy subject must be insured or beneficiary of a health insurance plan.

Who cannot join

  • The patient is under judicial protection.
  • The patient refuses to sign the consent.
  • It is impossible to correctly inform the patient (Inability to understand the study, language problem).
  • The patient has experienced a relapse in the previous 3 months.
  • The patient is pregnant or breast-feeding (MRI contraindicated).
  • Patient with MRI contra-indications (patient with a pacemaker, ferromagnetic vascular clip, infusion pump, neurostimulator, cochlear implants or in whom there is a suspicion of a metallic foreign body).
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  • The patient has a severe psychiatric illness
  • The patient has severe chronic alcoholism
  • For healthy subjects:
  • The healthy subject is under judicial protection.
  • It is impossible to correctly inform the healthy subject (Inability to understand the study, language problem).
  • The healthy subject is pregnant or breast-feeding (MRI contraindicated).
  • The healthy subject has MRI contra-indications (a pacemaker, ferromagnetic vascular clip, infusion pump, neurostimulator, cochlear implants or in whom there is a suspicion of a metallic foreign body).
  • The healthy subject has a history of disease that may affect the central nervous system.
  • The healthy subject has a family history of MS.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites

  • CHU de Lyon

    Lyon

  • CHU de Nancy

    Nancy

  • CHU de Nîmes

    Nîmes

  • CHU de Rennes

    Rennes

  • CHU de Strasbourg

    Strasbourg

Other trials in France

About this study

Official title: Very High Definition Cohort: Assessment of New Prognostic Biomarkers of Disability Worsening in a Multicenter Cohort of MS Patients by Imaging, Optical Coherence Tomography and Biology

Multiple sclerosis (MS) is the most common acquired neurological disease leading to disability in young adults. MS often leads to the development of a physical and/or cognitive impairment that disables patients in their daily lives. Early use of disease modifying treatments for patients at risk of developing disability is therefore essential.

However, disability progression is very heterogeneous between patients and currently impossible to predict at the individual level. Thus, numerous studies, particularly epidemiological and imaging studies, have identified prognostic factors for the development of disability such as age, gender, number of relapses during the first years of the disease, existence of a residual disability after a first relapse, number of gadolinium-enhancing lesions on initial MRI, early brainstem and spinal cord lesions. However, these different factors only explain incompletely the progression of the physical or cognitive disability in MS patients. In particular, some components of MS pathophysiology, more related to the progressive development of disability, such as axonal degeneration or the existence of chronic inflammation of the central nervous system (CNS) are usually not measured by these biomarkers.

Read more

In this research project, the investigators will test promising biomarkers, focused on these components of the disease, on a large cohort of patients in a multicenter setting, in order to evaluate their added value to predict disability progression, in comparison with more classical biomarkers such as clinical characteristics, and brain and spinal cord lesion load.

In particular, the investigators will test:

  • Imaging biomarkers extracted from brain and spinal cord MP2RAGE, brain and spinal cord QSM, brain and spinal cord relaxometry, brain diffusion and spinal cord magnetization transfer sequences
  • Biomarkers extracted from optical coherence tomography (OCT)
  • Biological biomarkers (serum neurofilament-light chain (NFL) and Glial Fibrillary Acidic Protein (GFAP))
Being tested
MRI
Keywords
Prognostic factors, MS progression, MRI, OCT, NFL, GFAP
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

    Comparison between groups

Study groups in NCT05622643
Study groupRoleWhat they receive
Patients with MS250 patients with MRI, OCT and bio sample
Receives: Other: MRI
Healthy subjects50 healthy subjects with MRI
Receives: Other: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Global disability progression

    Global disability progression will be scored by the Expanded disability score system (EDSS). Disability progression will be defined as an increase in the EDSS of at least 1 point if the baseline EDSS was 5.5 or less, or 0.5 point if the Baseline EDSS was

    Measured: 2 years

Secondary outcomes (9)

  1. Composite disability progression score

    A composite disability progression score will be defined as an increase in the EDSS score, or an increase in the time to perform the timed 25-foot walk ≥ 20%, or an increase in the time to complete the 9-hole peg test ≥ 20% at 2 years compared to baseline

    Measured: 2 years

  2. Change in the Symbol Digit Modalities Test score

    Change in the Symbol Digit Modalities Test (SDMT) score from baseline to 2-year

    Measured: 2 years

  3. Change in the American Spinal Cord Injury Association motor sub-score

    Change in the American Spinal Cord Injury Association (ASIA) motor sub-score from baseline to 2-year

    Measured: 2 years

  4. Focal inflammatory activity

    Focal inflammatory activity at 2 years will be defined by the occurrence of a clinical relapse and/or MRI activity (new T2 lesion)

    Measured: 2 years

  5. No evidence of disease activity 3

    No evidence of disease activity (NEDA) 3 at 2 years will be defined as no evidence of disability progression scored by the EDSS, relapse, MRI activity

    Measured: 2 years

  6. Between-subject, between-center and between-session coefficient of variation of measurements extracted quantitative MRI

    Between-subject, between-center and between-session coefficient of variation (in percentage) of measurements extracted from baseline brain and spinal cord quantitative MRI (T1, Myelin water fraction, magnetization transfer ratio, parameters extracted from diffusion imaging)

    Measured: At inclusion

  7. Number of brain and spinal cord lesion detected using 3D MP2RAGE sequence and the classical OFSEP sequences at baseline and 2 year

    Measured: At inclusion and 2 years

  8. Number of new brain and spinal cord lesion detected at 2 years using 3DMP2RAGE sequence and the classical OFSEP sequences

    Measured: 2 years

  9. Number of detected brain and spinal cord lesions per patient and per expert with and without the automatic tool at baseline and 2 year

    Measured: At baseline and 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2022
  2. Study start19 Jan 2023
  3. Primary completion1 Dec 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05622643
Sponsor's protocol ID
004
Acronym
VHD cohort
Status last verified
Jul 2026
First submitted
11 Oct 2022
Last updated
14 Jul 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, run by EDMUS Foundation at 5 sites 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 6 inclusion and 15 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Global disability progression (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05622643.

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 14 Jul 2026.

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