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

Multiple Sclerosis Clinical Trial

— RespiMuS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03339817
• Other study ID #: C16-111
• Secondary ID: 2017-A01845-48
• Status: Recruiting
• Phase: N/A
• Start date: January 11, 2018
• Est. completion date: January 10, 2020

Study information

• Verified date: October 2017
• Source: Institut National de la Santé Et de la Recherche Médicale, France
• Contact: Maillart Elisabeth, MD
• Phone: 01 42 16 19 75
• Email: elisabeth.maillart[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: January 10, 2020
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Respiration Disorders

Intervention

Diagnostic Test:
• Polysomnography
During polysomnographia and functional pulmonary testing, signs of diaphragmatic dysfunction responsible for respiratory disorders will be searched.

Locations

Country	Name	City	State
France	Département de Neurologie-Groupe Hospitalier Pitié-Salpêtrière	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Polysomnography	presence of phasic activation of respiratory muscles	Baseline only_during one night
Secondary	Respiratory function testing	difference between vital capacity upright and supine position (liter)	Baseline only
Secondary	Respiratory function testing	maximal inspiratory pressure (mmHg)	Baseline only
Secondary	Respiratory function testing	maximal expiratory pressure (mmHg)	Baseline only
Secondary	Respiratory function testing	SNIP (mmHg)	Baseline only
Secondary	Respiratory function testing	peak flow (liter)	Baseline only
Secondary	Cerebral and cervical spine MRI	cerebral : 3DT1MPRAGE, T2 FLAIR, DWI / spine: 3DT1MPRAGE, axial T2 MEDIC, T2-WSPACE	Baseline only
Secondary	Expanded Disability Status Scale (EDSS)	Neurological assessment of disability related to multiple sclerosis, total score from 0 to 10	Baseline only
Secondary	BICAMS	Brief International Assessment for Multiple Sclerosis	Baseline only