NCT02117375

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
115

participants targeted

Target at P75+ for not_applicable multiple-sclerosis

Timeline
Completed

Started Jan 2014

Longer than P75 for not_applicable multiple-sclerosis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 17, 2014

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
Last Updated

June 11, 2020

Status Verified

June 1, 2020

Enrollment Period

8.3 years

First QC Date

April 10, 2014

Last Update Submit

June 8, 2020

Conditions

Multiple Sclerosis

Keywords

multiple sclerosisspinal cordMRIlongitudinal studydisability

Outcome Measures

Primary Outcomes (1)

  • Progressive neurological disability

    Measurement by Expended Disability Status Scale

    5 years

Secondary Outcomes (4)

  • Progressive ambulatory disability

    5 years

  • Progressive disability in the upper limbs

    5 years

  • Progressive urinary disability

    5 years

  • Progressive difficulty walking

    5 years

Study Arms (2)

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

Device: spinal cord MRI follow-upOther: clinical follow-upOther: brain MRI follow-up

Healthy volunteers

EXPERIMENTAL

20 healthy volunteers (stability of spinal cord imaging) / spinal cord MRI follow-up at M0 and M24

Device: spinal cord MRI follow-up

Interventions

spinal cord MRI follow-upDEVICE

Evaluation : focal lesions (number, volume, localisation), atrophy, parameters from Diffusion Tensor Imaging and parameters from Magnetization Transfer Ratio

Healthy volunteersPatients with multiple sclerosis
clinical follow-upOTHER

Relapses, treatments, global disability,walking performance, upper limbs motor performance, sphincter disturbances and walking difficulty

Patients with multiple sclerosis
brain MRI follow-upOTHER
Patients with multiple sclerosis

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Multiple Sclerosis progressive
  • Patients treated with immunosuppressive therapy
  • Pregnancy
  • Healthy volunteers:
  • Age between 18 and 40 years
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Rennes

Rennes, France

Location

Related Publications (1)

  • 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.

    PMID: 30300751DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Gilles GE Edan

    CHU Rennes

    PRINCIPAL INVESTIGATOR

  • Bruno BB Brochet

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

  • Thibault TM Moreau

    CHU Dijon

    PRINCIPAL INVESTIGATOR

  • Sandra SV Vukusic

    Hospices civils Lyon

    PRINCIPAL INVESTIGATOR

  • Jean JP Pelletier

    AP-HM

    PRINCIPAL INVESTIGATOR

  • Marc MD Debouverie

    CHU NANCY

    PRINCIPAL INVESTIGATOR

  • Bruno BS Stankoff

    Pitié Salpêtrière

    PRINCIPAL INVESTIGATOR

  • Ayman AT Tourbah

    CHU REIMS

    PRINCIPAL INVESTIGATOR

  • Jérôme JD De Seze

    CHU Strasbourg

    PRINCIPAL INVESTIGATOR

  • David DB Brassat

    University Hospital, Toulouse

    PRINCIPAL INVESTIGATOR

  • Pierre PL Labauge

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

  • Thibaut TM Moreau

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 10, 2014

First Posted

April 17, 2014

Study Start

January 1, 2014

Primary Completion

April 1, 2022

Study Completion

July 1, 2022

Last Updated

June 11, 2020

Record last verified: 2020-06

Locations

FR(1)