Description Des Troubles Respiratoires Chez Les Patients Suivis Pour Une Sclérose En Plaques (SEP) Sévère
Not Applicable
Completed
- Conditions
- Multiple SclerosisRespiration Disorders
- Registration Number
- NCT03339817
- Lead Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- Brief Summary
The purpose of this study is to describe respiratory disorders in patients with severe multiple sclerosis (EDSS from 6.5).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
- Diagnosis criteria of multiple sclerosis (MS) fulfilling revised McDonald criteria (2010)
- EDSS score from 6.5
- no relapse during the 3 last months
- Informed consent prior to any study procedure
Exclusion Criteria
- Any severe Chronic Obstructive Pulmonary Disease (III or IV)
- Pregnancy or woman with childbearing potential
- contraindication to MRI
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Polysomnography Baseline only_during one night presence of phasic activation of respiratory muscles
- Secondary Outcome Measures
Name Time Method Expanded Disability Status Scale (EDSS) Baseline only Neurological assessment of disability related to multiple sclerosis, total score from 0 to 10
BICAMS Baseline only Brief International Assessment for Multiple Sclerosis
Respiratory function testing Baseline only peak flow (liter)
Cerebral and cervical spine MRI Baseline only cerebral : 3DT1MPRAGE, T2 FLAIR, DWI / spine: 3DT1MPRAGE, axial T2 MEDIC, T2-WSPACE
Trial Locations
- Locations (1)
Département de Neurologie-Groupe Hospitalier Pitié-Salpêtrière
🇫🇷Paris, France
Département de Neurologie-Groupe Hospitalier Pitié-Salpêtrière🇫🇷Paris, France