Multiple Sclerosis, Respiration Disorders
Conditions
Brief summary
The purpose of this study is to describe respiratory disorders in patients with severe multiple sclerosis (EDSS from 6.5).
Interventions
DIAGNOSTIC_TESTPolysomnography
During polysomnographia and functional pulmonary testing, signs of diaphragmatic dysfunction responsible for respiratory disorders will be searched.
Sponsors
Institut National de la Santé Et de la Recherche Médicale, France
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Polysomnography | Baseline only_during one night | presence of phasic activation of respiratory muscles |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory function testing | Baseline only | difference between vital capacity upright and supine position (liter) |
| Cerebral and cervical spine MRI | Baseline only | cerebral : 3DT1MPRAGE, T2 FLAIR, DWI / spine: 3DT1MPRAGE, axial T2 MEDIC, T2-WSPACE |
| 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 |
Countries
France
Outcome results
None listed