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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01350297
Recruitment Status : Completed
First Posted : May 9, 2011
Last Update Posted : June 18, 2013
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
Primary Completion Date : June 2013
Study Completion Date : June 2013

Arm Intervention/treatment
Experimental: 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 ]

Information from the National Library of Medicine

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

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 identifier (NCT number): NCT01350297

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

Responsible Party: University Hospital, Rouen 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:
phrenic nerve

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