Description Des Troubles Respiratoires Chez Les Patients Suivis Pour Une Sclérose en Plaques (SEP) sévère

Institut National de la Santé Et de la Recherche Médicale, France70 enrolled

Overview

The purpose of this study is to describe respiratory disorders in patients with severe multiple sclerosis (EDSS from 6.5).

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Multiple Sclerosis Respiration Disorders

Interventions

PolysomnographyDIAGNOSTIC_TEST

During polysomnographia and functional pulmonary testing, signs of diaphragmatic dysfunction responsible for respiratory disorders will be searched.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Département de Neurologie-Groupe Hospitalier Pitié-Salpêtrière

Paris, Paris, France

Outcomes

Primary Outcomes

Polysomnography

presence of phasic activation of respiratory muscles

Time frame: Baseline only_during one night

Secondary Outcomes

Respiratory function testing

difference between vital capacity upright and supine position (liter)

Time frame: Baseline only

Respiratory function testing

maximal inspiratory pressure (mmHg)

Time frame: Baseline only

Respiratory function testing

maximal expiratory pressure (mmHg)

Time frame: Baseline only

Respiratory function testing

SNIP (mmHg)

Time frame: Baseline only

Respiratory function testing

peak flow (liter)

Time frame: Baseline only

Cerebral and cervical spine MRI

cerebral : 3DT1MPRAGE, T2 FLAIR, DWI / spine: 3DT1MPRAGE, axial T2 MEDIC, T2-WSPACE

Time frame: Baseline only

Expanded Disability Status Scale (EDSS)

Neurological assessment of disability related to multiple sclerosis, total score from 0 to 10

Time frame: Baseline only

BICAMS

Brief International Assessment for Multiple Sclerosis

Data from ClinicalTrials.gov

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