Multiple SclerosisEMISEPNCT02117375
EMISEP : Early Spinal Cord Lesions and Late Disability in Relapsing Remitting Multiple Sclerosis Patients
A study testing spinal cord MRI follow-up, clinical follow-up and brain MRI follow-up in people with Multiple Sclerosis, run by Rennes University Hospital at 1 site in France.
Trial summary
The purpose of this study is to evaluate the prognostic value of early focal lesions and early diffuse lesions on ambulatory disability progression within 5 years after clinical onset. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- spinal cord MRI follow-up, clinical follow-up and brain MRI follow-up
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 115 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2014to 24 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Relapsing Remitting Multiple Sclerosis patients (Mac Donald 2010 criteria)
- First clinical event < 1 year
- Brain MRI > 9 lesions or/and spinal cord attack with focal lesion on spinal cord MRI
- Score Expended Disability Status Scale < 3
- Age between 18 and 40 years
- -Age between 18 and 40 years
Who cannot join
- Multiple Sclerosis progressive
- Patients treated with immunosuppressive therapy
- Pregnancy
- Healthy volunteers:
- -Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the prognostic value of early focal lesions and early diffuse lesions on ambulatory disability progression within 5 years after clinical onset.
Read the detailed description
Prospective, multicentric study
- Conditions
- Multiple Sclerosis
- Being tested
- spinal cord MRI follow-up, clinical follow-up, brain MRI follow-up
- Keywords
- multiple sclerosis, spinal cord, MRI, longitudinal study, disability
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
spinal cord MRI follow-upDevice
Evaluation : focal lesions (number, volume, localisation), atrophy, parameters from Diffusion Tensor Imaging and parameters from Magnetization Transfer Ratio
clinical follow-upOther
Relapses, treatments, global disability,walking performance, upper limbs motor performance, sphincter disturbances and walking difficulty
brain MRI follow-upOther
| Study group | Role | What they receive |
|---|---|---|
| Patients with multiple sclerosis | Experimental | 80 patients / clinical Follow-up at M0, M6, M12, M18, M24, M30, M36, M42, M48, M54 and M60 / spinal cord MRI follow-up at M0, M12, M24, M36 and M60 / brain MRI follow-up at M0, M12, M24, M36 and M60 Receives: Device: spinal cord MRI follow-up; Other: clinical follow-up; Other: brain MRI follow-up |
| Healthy volunteers | Experimental | 20 healthy volunteers (stability of spinal cord imaging) / spinal cord MRI follow-up at M0 and M24 Receives: Device: spinal cord MRI follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progressive neurological disability
Measurement by Expended Disability Status Scale
Measured: 5 years
Secondary outcomes (4)
Progressive ambulatory disability
Measurement by the 25-foot timed-Walked test and 6 minutes walking
Measured: 5 years
Progressive disability in the upper limbs
Measurement by the nine-hole peg test
Measured: 5 years
Progressive urinary disability
Measurement by the questionnaire Qualiveen
Measured: 5 years
Progressive difficulty walking
Measurement by the Multiple Sclerosis Walking Scale 12
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2014 (estimated)
- Study startJan 2014
- Primary completion24 Jan 2023
- Study completion24 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Rennes 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gilles GE Edan, Principal investigator, Rennes University HospitalBruno BB Brochet, Principal investigator, University Hospital, BordeauxThibault TM Moreau, Principal investigator, CHU DijonSandra SV Vukusic, Principal investigator, Hospices civils LyonJean JP Pelletier, Principal investigator, AP-HMMarc MD Debouverie, Principal investigator, Central Hospital, Nancy, FranceBruno BS Stankoff, Principal investigator, Pitié SalpêtrièreAyman AT Tourbah, Principal investigator, CHU de Reims
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02117375
- Sponsor's protocol ID
- 2013-A00333-42
- Other IDs
- PHRC/12-07
- Acronym
- EMISEP
- Status last verified
- Jun 2026
- First submitted
- 10 Apr 2014
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gros C, De Leener B, Badji A, Maranzano J, Eden D, Dupont SM, Talbott J, Zhuoquiong R, Liu Y, Granberg T, Ouellette R, Tachibana Y, Hori M, Kamiya K, Chougar L, Stawiarz L, Hillert J, Bannier E, Kerbrat A, Edan G, Labauge P, Callot V, Pelletier J, Audoin B, Rasoanandrianina H, Brisset JC, Valsasina P, Rocca MA, Filippi M, Bakshi R, Tauhid S, Prados F, Yiannakas M, Kearney H, Ciccarelli O, Smith S, Treaba CA, Mainero C, Lefeuvre J, Reich DS, Nair G, Auclair V, McLaren DG, Martin AR, Fehlings MG, Vahdat S, Khatibi A, Doyon J, Shepherd T, Charlson E, Narayanan S, Cohen-Adad J. Automatic segmentation of the spinal cord and intramedullary multiple sclerosis lesions with convolutional neural networks. Neuroimage. 2019 Jan 1;184:901-915. doi: 10.1016/j.neuroimage.2018.09.081. Epub 2018 Oct 6.
PubMed 30300751
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMISEP : Early Spinal Cord Lesions and Late Disability in Relapsing Remitting Multiple Sclerosis Patients
- ClinicalTrials.gov ID
- NCT02117375
- Acronym / sponsor ID
- EMISEP / 2013-A00333-42
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, spinal cord, MRI, longitudinal study, disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 115 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- 24 Jan 2023 (actual)
- Study completion
- 24 Jan 2024 (actual)
- First posted
- 17 Apr 2014 (estimated)
- 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 purpose of this study is to evaluate the prognostic value of early focal lesions and early diffuse lesions on ambulatory disability progression within 5 years after clinical onset.
Detailed description
Prospective, multicentric study
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with multiple sclerosis | Experimental | Device: spinal cord MRI follow-up, Other: clinical follow-up, Other: brain MRI follow-up80 patients / clinical Follow-up at M0, M6, M12, M18, M24, M30, M36, M42, M48, M54 and M60 / spinal cord MRI follow-up at M0, M12, M24, M36 and M60 / brain MRI follow-up at M0, M12, M24, M36 and M60 |
| Healthy volunteers | Experimental | Device: spinal cord MRI follow-up20 healthy volunteers (stability of spinal cord imaging) / spinal cord MRI follow-up at M0 and M24 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Relapsing Remitting Multiple Sclerosis patients (Mac Donald 2010 criteria)
- First clinical event < 1 year
- Brain MRI > 9 lesions or/and spinal cord attack with focal lesion on spinal cord MRI
- Score Expended Disability Status Scale < 3
- Age between 18 and 40 years
Key exclusion criteria (5 listed)
- Multiple Sclerosis progressive
- Patients treated with immunosuppressive therapy
- Pregnancy
- -Pregnancy
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 |
|---|---|---|
| spinal cord MRI follow-upEvaluation : focal lesions (number, volume, localisation), atrophy, parameters from Diffusion Tensor Imaging and parameters from Magnetization Transfer Ratio | Device | Healthy volunteers, Patients with multiple sclerosis |
| clinical follow-upRelapses, treatments, global disability,walking performance, upper limbs motor performance, sphincter disturbances and walking difficulty | Other | Patients with multiple sclerosis |
| brain MRI follow-up | Other | Patients with multiple sclerosis |
Primary outcome
Progressive neurological disability
Time frame: 5 years
Measurement by Expended Disability Status Scale
4 secondary outcomes
Progressive ambulatory disability
Time frame: 5 years
Progressive disability in the upper limbs
Time frame: 5 years
Progressive urinary disability
Time frame: 5 years
Progressive difficulty walking
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
- Derived from this study: PubMed 30300751Gros C, De Leener B, Badji A, Maranzano J, Eden D, Dupont SM, Talbott J, Zhuoquiong R, Liu Y, Granberg T, Ouellette R, Tachibana Y, Hori M, Kamiya K, Chougar L, Stawiarz L, Hillert J, Bannier E, Kerbrat A, Edan G, Labauge P, Callot V, Pelletier J, Audoin B, Rasoanandrianina H, Brisset JC, Valsasina P, Rocca MA, Filippi M, Bakshi R, Tauhid S, Prados F, Yiannakas M, Kearney H, Ciccarelli O, Smith S, Treaba CA, Mainero C, Lefeuvre J, Reich DS, Nair G, Auclair V, McLaren DG, Martin AR, Fehlings MG, Vahdat S, Khatibi A, Doyon J, Shepherd T, Charlson E, Narayanan S, Cohen-Adad J. Automatic segmentation of the spinal cord and intramedullary multiple sclerosis lesions with convolutional neural networks. Neuroimage. 2019 Jan 1;184:901-915. doi: 10.1016/j.neuroimage.2018.09.081. Epub 2018 Oct 6.
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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. This study is not recruiting at the moment.
Gilles GE Edan principal investigator
Rennes University Hospital
Bruno BB Brochet principal investigator
University Hospital, Bordeaux
Thibault TM Moreau principal investigator
CHU Dijon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing spinal cord MRI follow-up, clinical follow-up and brain MRI follow-up in people with Multiple Sclerosis, run by Rennes 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 6 inclusion and 5 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: finished, as of the sponsor's last update on 15 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Progressive neurological disability (time frame: 5 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 NCT02117375, which also lists 1 linked publication.
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 15 Jun 2026.