Multiple Sclerosis Clinical Trial
— WHINUMEOfficial title:
3D OPTIMIZED WMN MPRAGE Increased Detection of Focal Spinal Cord Lesion in Multiple Sclerosis (WHINUME)
The aim of this study is to compare the 3D OPTIMIZED MPRAGE WMN sequence to "conventional sequences" used in spinal cord analysis. The patients will be explored at the cervical level with the conventional 2D sagittal T2 FSE, 2D sagittal STIR, 2D sagittal PSIR, 3D T1 MPRAGE sequences, and the sequence of interest 3D sagittal OPTIMIZED WMN MPRAGE and 3D axial OPTIMIZED WMN MPRAGE. At the thoracic level, with the conventional 2D sagittal T2 FSE, 2D sagittal STIR, 3D T1 MPRAGE sequences and the sequence of interest 3D sagittal OPTIMIZED WMN MPRAGE.
Status | Recruiting |
Enrollment | 60 |
Est. completion date | May 1, 2026 |
Est. primary completion date | May 1, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients older than 18 years old - CIS or RRMS - Medullary symptomatology less than 6 months - With or without an objective lesion on a subsequent MRI scan - Signed the Informed Consent Exclusion Criteria: - Pregnant or potentially pregnant women - Breastfeeding woman - Contraindications to MRI - Other diagnosis (Neuro-myelitis spectrum disease or Progressive Multiple Sclerosis) - Surgical history on the spinal cord or lumbar spine - Patient under legal protection |
Country | Name | City | State |
---|---|---|---|
France | CHU de Bordeaux | Bordeaux |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | lesions at the cervical level | number of lesions at the cervical level for the 3D optimized WMN MPRAGE sequence compared to "conventional sequences" | day 1 | |
Secondary | lesions at the thoracic level | The number of lesions at the thoracic level for the 3D optimized WMN MPRAGE sequence compared to "conventional sequences" | day 1 | |
Secondary | sensitivity of the 3D optimised WMN MPRAGE sequence | For the total number of lesions detected, the sensitivity of the 3D optimised WMN MPRAGE sequence compared to "conventional sequences". | day 1 | |
Secondary | positive predictive value of the 3D optimized WMN MPRAGE sequence | For the total number of lesions detected and the positive predictive value of the 3D optimized WMN MPRAGE sequence compared to "conventional sequences | day 1 | |
Secondary | Intraclass corelation coefficient | The reproducibility of the number of lesions will be assessed via two radiologists analysing the 3D WMN MPRAGE sequences and the "conventional sequences" twice | day 1 | |
Secondary | pathogenicity of the lesions | Confidence in the pathogenicity of the lesions with a quantitative scale on each lesion detected at the cervical and thoracic level: 1) corresponding to a very low confidence, 2) moderate and 3) a very high confidence. | day 1 | |
Secondary | presence of artefacts | The presence of artefacts at the cervical and thoracic level defined by a confidence scale: 1) corresponding to no artefacts, 2) minor artefacts, 3) moderate artefacts, 4) major artefacts, and 5) major artefacts | day 1 | |
Secondary | volume of lesion | The volume (mm3) for 20 randomly selected patients, using a distinct, visible lesion at the cervical level to be detected on the "sequence of interest" and "conventional sequences". | day 1 | |
Secondary | contrast-to-noise ratio | The contrast-to-noise ratio (CNR) calculated with [CNR = (Lesion Signal - Cord Signal) / Noise] for 20 randomly selected patients, using a distinct, visible lesion at the cervical level to be detected on the "sequence of interest" and "conventional sequences". | day 1 | |
Secondary | patient's disability | The assessment of the patient's disability using the EDSS clinical scale (from 0-normal neurologic exam to 100-death). | day 1 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05528666 -
Risk Perception in Multiple Sclerosis
|
||
Completed |
NCT03608527 -
Adaptive Plasticity Following Rehabilitation in Multiple Sclerosis
|
N/A | |
Recruiting |
NCT05532943 -
Evaluate the Safety and Efficacy of Allogeneic Umbilical Cord Mesenchymal Stem Cells in Patients With Multiple Sclerosis
|
Phase 1/Phase 2 | |
Completed |
NCT02486640 -
Evaluation of Potential Predictors of Adherence by Investigating a Representative Cohort of Multiple Sclerosis (MS) Patients in Germany Treated With Betaferon
|
||
Completed |
NCT01324232 -
Safety and Efficacy of AVP-923 in the Treatment of Central Neuropathic Pain in Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT04546698 -
5-HT7 Receptor Implication in Inflammatory Mechanisms in Multiple Sclerosis
|
||
Active, not recruiting |
NCT04380220 -
Coagulation/Complement Activation and Cerebral Hypoperfusion in Relapsing-remitting Multiple Sclerosis
|
||
Completed |
NCT02835677 -
Integrating Caregiver Support Into MS Care
|
N/A | |
Completed |
NCT03686826 -
Feasibility and Reliability of Multimodal Evoked Potentials
|
||
Recruiting |
NCT05964829 -
Impact of the Cionic Neural Sleeve on Mobility in Multiple Sclerosis
|
N/A | |
Withdrawn |
NCT06021561 -
Orofacial Pain in Multiple Sclerosis
|
||
Completed |
NCT03653585 -
Cortical Lesions in Patients With Multiple Sclerosis
|
||
Recruiting |
NCT04798651 -
Pathogenicity of B and CD4 T Cell Subsets in Multiple Sclerosis
|
N/A | |
Active, not recruiting |
NCT05054140 -
Study to Evaluate Efficacy, Safety, and Tolerability of IMU-838 in Patients With Progressive Multiple Sclerosis
|
Phase 2 | |
Completed |
NCT05447143 -
Effect of Home Exercise Program on Various Parameters in Patients With Multiple Sclerosis
|
N/A | |
Recruiting |
NCT06195644 -
Effect of Galvanic Vestibular Stimulation on Cortical Excitability and Hand Dexterity in Multiple Sclerosis Patients
|
Phase 1 | |
Completed |
NCT04147052 -
iSLEEPms: An Internet-Delivered Intervention for Sleep Disturbance in Multiple Sclerosis
|
N/A | |
Completed |
NCT03591809 -
Combined Exercise Training in Patients With Multiple Sclerosis
|
N/A | |
Completed |
NCT03594357 -
Cognitive Functions in Patients With Multiple Sclerosis
|
||
Completed |
NCT02845635 -
MS Mosaic: A Longitudinal Research Study on Multiple Sclerosis
|