Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis

Study Overview
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Brief Summary
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Selective laryngeal bilateral reinnervation as a secondary treatment in patients with bilateral vocal fold paralysis, previously treated by endoscopy, without residual arytenoids ankylosis. The surgical procedure is : functional reinnervation with the upper root of one phrenic nerve, is used for reinnervation of both cricoarytenoid muscles (laryngeal inspiratory muscles), and simultaneous reinnervation of adductor laryngeal muscles is performed by right and left thyro -hyoid nerves (coming from the hypoglossi) on both sides. Results are obtained after 6 to 9 months delay. In case of good inspiratory arytenoid abduction, and residual dysphonia, a secondary vocal fold medialization is done by an endoscopic approach 12 months after reinnervation (included in the protocol). Improvement is expected in voice and breathing, without aspiration.

Official Title
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Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis: Analysis of Phonatory and Ventilatory Results

Conditions
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Bilateral Vocal Fold Paralysis

Intervention / Treatment
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* Procedure: Surgery for bilateral laryngeal reinnervation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with Bilateral vocal fold paralysis in a closure position 6 months to 36 months before. Patient who has been treated by endoscopic treatment without satisfying result (voice or breathing). Patient with passive mobile arytenoid at least on one side Tracheostomized or not Age > 18 years old Good general situation Exclusion Criteria: Long term vocal fold paralysis (more than 3 years with strong denervation) Ary-cricoid ankylosis or synechiae Age >75 years Anaesthesiologist contra indication Strong respiratory disease history Severe coagulation troubles Ongoing neoplasia disease Cardiac pace maker Pregnant woman or without contraception Impairment of the freedom

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with bilateral vocal fold paralysis<br>Patient with bilateral vocal fold paralysis in a closure position between 6 months to 36 months before et who has been treated by endoscopic treatment without satisfying result (voice or breathing). | Procedure: Surgery for bilateral laryngeal reinnervation<br>* Surgery for bilateral laryngeal reinnervation assessed for patient with bilateral vocal fold paralysis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal phonation time | Maximal phonation time will be assessed at 18 Months | 18 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Voice quality assessed using quality of life questionnaire | Voice quality will be assessed using quality of life questionnaire, computerized analysis, swallowing scores | 18 Months | 
| Voice quality assessed using computerized analysis | Voice quality will be assessed using computerized analysis | 18 Months | 
| Voice quality assessed using swallowing scores | Voice quality will be assessed using swallowing scores | 18 Months |