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Diaphragmatic Reinnervation of Tetraplegic Patients With Respiratory Insufficiency (TETRADIA-UNI)

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ClinicalTrials.gov Identifier: NCT01350297
Recruitment Status : Completed
First Posted : May 9, 2011
Last Update Posted : June 18, 2013
Sponsor:
Information provided by (Responsible Party):
University Hospital, Rouen

Brief Summary:
This study evaluates the diaphragmatic reinnervation by inferior laryngeal nerve in tetraplegic patients with ventilatory insufficiency.

Condition or disease Intervention/treatment Phase
Tetraplegia Procedure: reinnervation Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phrenic Reinnervation in Central Ventilatory Paralysis Due to Medullary Trauma With Phrenic Motoneuron Destruction
Study Start Date : March 2010
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Arm Intervention/treatment
Experimental: Patients
Patients
Procedure: reinnervation
anastomosis between right inferior laryngeal nerve and right phrenic nerve
Other Name: laryngeal reinnervation




Primary Outcome Measures :
  1. recovery of spontaneous ventilation [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • tetraplegia c3-c4
  • respiratory insufficiency

Exclusion Criteria:

  • PM

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01350297


Locations
France
VERIN
Rouen, France, 76031
Sponsors and Collaborators
University Hospital, Rouen
Investigators
Study Chair: VERIN Eric, MD University Hospital, Rouen

Responsible Party: University Hospital, Rouen
ClinicalTrials.gov Identifier: NCT01350297     History of Changes
Other Study ID Numbers: 2009/023/HP
First Posted: May 9, 2011    Key Record Dates
Last Update Posted: June 18, 2013
Last Verified: June 2013

Keywords provided by University Hospital, Rouen:
tetraplegia
reinnervation
phrenic nerve

Additional relevant MeSH terms:
Respiratory Insufficiency
Quadriplegia
Respiration Disorders
Respiratory Tract Diseases
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms