Early UVFP Management Based on Neurological Evidences (UVFP = Unilateral Vocal Fold Paralysis)

Study Overview
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Brief Summary
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The aim of this study is to understand how early intervention could impact reinnervation of the recurrent laryngeal nerve (which innervates the vocal cord), recovery of mobility of the paralyzed vocal cord and / or vocal recovery in the case of unilateral vocal fold paralysis. To achieve this goal we must therefore carry out a complete outcomes assessment of different intervention methods (voice therapy and injection laryngoplasty), which are offered to UVFP (unilateral vocal fold paralysis) patients in the early stage (< 3 months). Their respective impacts on the central and peripheral nervous system and on the voice quality will be assessed, taking into account factors related to the severity of the paralysis.

Official Title
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Early UVFP Management Based on Neurological Evidences UVFP = Unilateral Vocal Fold Paralysis

Conditions
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Unilateral Vocal Cord Paralysis

Intervention / Treatment
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* Procedure: Acid hyaluronic injection laryngoplasty
* Behavioral: Voice therapy
* Other: Sham of injection
* Other: Sham of voice therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Unilateral paralysis in abduction of the vocal cords may be included in the study. Exclusion Criteria: Wear a pacemaker or other implanted devices (prostheses ...). Wear metal clips, metal in the head, or an adjustable brain drain. Wear non-removable dental appliances (except fillings). Wear cardiac valve prostheses. Have worked the metals. Have a tattoo containing metal particles. Have implanted jewelry (e.g., piercing). Being prone to epileptic seizures. Take medications that alter cortical excitability. Have had a brain surgery. Suffer from intracranial hypertension. Be pregnant or breastfeeding recently. Present allergies that are incompatible with the experimental protocol. Have an abnormal hearing loss in view of their age, identified with tonal and / or vocal audiometry.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injection laryngoplasty group (IL)<br>The patients in the first group will receive an IL of hyaluronic acid in the paralyzed vocal fold within a maximum of three months after the onset of symptoms. The Ear-Noise-Throat (ENT) physician will perform the injection in office, under topical anaesthesia. | Procedure: Acid hyaluronic injection laryngoplasty<br>* Hyaluronic acid is injected into the paralyzed vocal fold<br>Other: Sham of voice therapy<br>* 15 sessions of thirty minutes of voice therapy, twice a week, and home practice. This voice management will not be specific to UVFP but may allow patients to improve their vocal gesture.<br>|
| Experimental: Voice therapy group (VT)<br>Patients from the second group will be involved in 15 sessions of thirty minutes of voice therapy, twice a week, and will have to do home practice. Patients will have to record these training sessions. Initiation of this intervention should also take place within the first three months after the onset of symptoms. They will also receive an injection of physiological saline under the skin of the neck (sham of injection). | Behavioral: Voice therapy<br>* 15 sessions of thirty minutes of voice therapy, twice a week, and home practice. This voice management will be specific to unilateral vocal fold paralysis and will focus on three objectives: reinforcement of the vocal muscle, glottal closure and glottal opening. These three objectives will be worked through different vocal exercises (on voiced phonemes) and breathing exercises<br>Other: Sham of injection<br>* Injection of physiological saline under the skin of the neck (sham of injection).<br>|
| Sham Comparator: Sham group<br>The patients of the third group will be treated following the traditional wait-and-see policy. They will receive an injection of physiological saline under the skin of the neck and will be seen during 15 sessions of 30 minutes, twice a week. Therefore, this will be a sham procedure for both IL and VT. | Other: Sham of injection<br>* Injection of physiological saline under the skin of the neck (sham of injection).<br>Other: Sham of voice therapy<br>* 15 sessions of thirty minutes of voice therapy, twice a week, and home practice. This voice management will not be specific to UVFP but may allow patients to improve their vocal gesture.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laryngeal recurrent nerve reinnervation | Defined through qualitative laryngeal electromyography | 9 to 12 months after paralysis | 
| Recovery of the vocal fold mobility | Videostroboscopy examination to analyse vocal folds movements in three dimensions | 9 to 12 months after paralysis | 
| Voice recovery | Multidimensional voice assessment (based on anamnestic interview, Maximum Phonation Time in sec, Mean Air Flow in ml/sec, Mean subglottic pressure in cmH2O, Jitter in %, Shimmer in %, Noise-to-harmonic ratio, phonetogram, smoothed cepstral peak prominence in %, Voice Handicap Index - VHI-30 (*total* : 0-120, higher value = worse outcome), Medical Outcomes Study 36-item Short Form Healthy Survey (*8 subscales* : 0-100, higher value = better outcome, Eating Assessment Tool-10 (*total*: 0-40, higher value = worse outcome), GRBAS-I (*6 subscales* : 0-3, higher value = worse outcome), Acoustic Voice Quality Index, Dysphonia Severity Index (DSI = 0.13 x MPT + 0.0053 x F(0)-High - 0.26 x I-Low - 1.18 x Jitter (%) + 12.4),Tonal and vocal audiometries in dB) | 9 to 12 months after paralysis | 
| Changes in the neuronal pathways involved in the processing of the proprioceptive and auditory inputs | Functional magnetic resonance imaging examination (tomodensitometry and connectivity) | 9 to 12 months after paralysis | 
| Central auditory processes | Auditory perception tasks performed using an audio headset | Within 3 months after paralysis |