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MRI Biomarkers Predictive of Disability Progression in Patients With Multiple Sclerosis

Primary Purpose

Multiple Sclerosis, Magnetic Resonance Spectroscopy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
magnetic resonance spectroscopy
Sponsored by
Poitiers University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Multiple Sclerosis focused on measuring Multiple sclerosis, ultra-high field 7T magnetic resonance spectroscopy, sodium imaging, predictive MR biomarker of MS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 years,
  • Duration of disease ≤ 25 years,
  • EDSS ≥ 3,
  • Irreversible disability ≤ 7 (permanent wheelchair use) on the EDSS scale

Exclusion Criteria:

  • 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,
  • 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)

Sites / Locations

  • PoitiersUHRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Multiple sclerosis

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Determine the correlation between brain MRI and the concentration of imaging biomarkers (mmols) at 6, 12, 18 and 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.
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.

Full Information

First Posted
April 5, 2022
Last Updated
September 13, 2023
Sponsor
Poitiers University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05491031
Brief Title
MRI Biomarkers Predictive of Disability Progression in Patients With Multiple Sclerosis
Official Title
Evaluation of MRI Biomarkers Predictive of Disability Progression in Patients With Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2023 (Actual)
Primary Completion Date
January 1, 2028 (Anticipated)
Study Completion Date
May 1, 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Magnetic Resonance Spectroscopy
Keywords
Multiple sclerosis, ultra-high field 7T magnetic resonance spectroscopy, sodium imaging, predictive MR biomarker of MS

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Multiple sclerosis
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
magnetic resonance spectroscopy
Intervention Description
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)
Primary Outcome Measure Information:
Title
Identify imaging biomarkers at inclusion predictive of disability progression.
Description
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).
Time Frame
up to 24 months
Secondary Outcome Measure Information:
Title
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
Title
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).
Description
Mathematical models of disease progression using the concentration of biomarkers (in mmol) associated with clinical evaluation of disability (EDSS-plus) over a dynamic period.
Time Frame
up to 24 months
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years, Duration of disease ≤ 25 years, Irreversible disability ≤ 7 (permanent wheelchair use) on the EDSS scale Exclusion Criteria: 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, 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amelie Dos Santos, Dr
Phone
+33.5.49.44.44.46
Email
amelie.dos-santos@chu-poitiers.fr
Facility Information:
Facility Name
PoitiersUH
City
Poitiers
ZIP/Postal Code
86000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amélie Dos Santos

12. IPD Sharing Statement

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MRI Biomarkers Predictive of Disability Progression in Patients With Multiple Sclerosis

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