Bulbar Function in Neuromuscular Patients

NCT ID: NCT02097368

Last Updated: 2018-01-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2020-12-31

Brief Summary

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The main objective is prospectively study the upper airways function in an adult population of neuromuscular patients. The main measurement will be the evolution of tongue strength recorded each year during annual clinical evaluation on a 5 years period.

Detailed Description

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The main objective is to study the function of the superior airways (tongue and pharynx) in an non invasive way in neuromuscular patients followed in the home ventilation unit of the Raymond POINCARE hospital (myopathy, neuropathy, disease of the neuromuscular junction or anterior horn) or of Necker Hospital and to detect prematurely the bulbar dysfunction.

The secondary objectives of this prospective monocentric observational physiopathological study are:

1. to study the correlation between the possible swallowing dysfunction and the anomalies of the respiratory parameters
2. to establish correlations between infraclinical or clinical and presence of morphological tongue anomalies detected by magnetic resonance imaging like in acid maltase deficiency.

The maximal tongue strength protrusion will be measured according to a method already used in the laboratory to explore sleep apnea syndromes.

Swallowing will be estimated by a non invasive method already used to highlight swallowing disorders in neurological and muscular pathologies This method will be associated with a method of recording of thoracic and abdominal movements.

Data wil be compared to a control database obtained for a previous study

Conditions

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Neuromuscular Diseases

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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neuromuscular patient

Patients affected by neuromuscular pathology will be explored by tongue strength measurement, respiratory function measurement, swallowing tests and Magnetic resonance imaging

tongue strength measurement

Intervention Type PROCEDURE

tongue strength measurement

respiratory function measurement

Intervention Type PROCEDURE

respiratory function measurement

swallowing tests

Intervention Type PROCEDURE

swallowing tests

Magnetic resonance imaging

Intervention Type OTHER

Magnetic resonance imaging

Interventions

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tongue strength measurement

tongue strength measurement

Intervention Type PROCEDURE

respiratory function measurement

respiratory function measurement

Intervention Type PROCEDURE

swallowing tests

swallowing tests

Intervention Type PROCEDURE

Magnetic resonance imaging

Magnetic resonance imaging

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* neuromuscular disorder
* age greater than or equal to 6
* Hospitalization in Home Ventilation Unit - Written informed consent

Exclusion Criteria

* patient's refusal to participate
* major swallowing disfunction
* Acute respiratory failure
* no affiliation to social security
Minimum Eligible Age

6 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre d'Investigation Clinique et Technologique 805

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Orlikowski, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre d'Investigation Clinique et Technologique 805

Helene Prigent, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Centre d'Investigation Clinique et Technologique 805

Frederic Lofaso, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Centre d'Investigation Clinique et Technologique 805

Locations

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Home Ventilation Unit, Raymond Poincare Hospital

Garches, , France

Site Status RECRUITING

Non invasive ventilation Unit - Necker Hospital

Paris, , France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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David Orlikowski, MD PhD

Role: CONTACT

33147107777

Frederic Barbot, MD

Role: CONTACT

33147104474

Facility Contacts

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David Orlikowski, MD, PhD

Role: primary

33 1 47 10 77 77

Marjorie Figere, CRA

Role: backup

33147104615

David Orlikowski, PHD

Role: primary

0033147107777

Other Identifiers

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2013-A00601-44

Identifier Type: -

Identifier Source: org_study_id

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