Multiple SclerosisNCT05491031
MRI Biomarkers Predictive of Disability Progression in Patients With Multiple Sclerosis
A study testing magnetic resonance spectroscopy in people with Multiple Sclerosis and Magnetic Resonance Spectroscopy, run by Poitiers University Hospital at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Magnetic Resonance Spectroscopy
- What is being tested?
- magnetic resonance spectroscopy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 25 Apr 2023to 1 May 2030
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥ 18 years,
- Duration of disease ≤ 25 years,
- Irreversible disability ≤ 7 (permanent wheelchair use) on the EDSS scale
Who cannot join
- 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,
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- 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)
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
PoitiersUH
Poitiers, 86000
Amélie Dos Santos
About this study
Official title: Evaluation of 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.
Read more
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.
- Being tested
- magnetic resonance spectroscopy
- Keywords
- Multiple sclerosis, ultra-high field 7T magnetic resonance spectroscopy, sodium imaging, predictive MR biomarker of MS
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
magnetic resonance spectroscopyOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Multiple sclerosis | Experimental | Not described Receives: Other: magnetic resonance spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify imaging biomarkers at inclusion predictive of disability progression.
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).
Measured: up to 24 months
Secondary outcomes (3)
Determine the correlation between brain MRI and the concentration of imaging biomarkers (mmols) at 6, 12, 18 and 24 months.
Measured: up to 24 months
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).
Mathematical models of disease progression using the concentration of biomarkers (in mmol) associated with clinical evaluation of disability (EDSS-plus) over a dynamic period.
Measured: up to 24 months
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.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start25 Apr 2023
- Primary completion1 May 2030 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491031
- Sponsor's protocol ID
- MR7T-PRADIMS
- Status last verified
- May 2026
- First submitted
- 5 Apr 2022
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of MRI Biomarkers Predictive of Disability Progression in Patients With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT05491031
- Acronym / sponsor ID
- MR7T-PRADIMS
- Keywords
- Multiple sclerosis, ultra-high field 7T magnetic resonance spectroscopy, sodium imaging, predictive MR biomarker of MS
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 1 May 2030 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 8 Aug 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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Multiple sclerosis | Experimental | Other: magnetic resonance spectroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18 years,
- Duration of disease ≤ 25 years,
- Irreversible disability ≤ 7 (permanent wheelchair use) on the EDSS scale
Key exclusion criteria (10 listed)
- 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,
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 |
|---|---|---|
| magnetic resonance spectroscopyInvestigation 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) | Other | Multiple sclerosis |
Primary outcome
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).
3 secondary outcomes
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
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
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
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 5 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing magnetic resonance spectroscopy in people with Multiple Sclerosis and Magnetic Resonance Spectroscopy, run by Poitiers University Hospital 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 3 inclusion and 10 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 5 May 2026. 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 Amelie Dos Santos, Dr (+33.5.49.44.44.46, amelie.dos-santos@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify imaging biomarkers at inclusion predictive of disability progression. (time frame: up to 24 months). 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 5 May 2026.