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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Unilateral Vocal Cord Paralysis
• Intervention / Treatment: Procedure: Acid hyaluronic injection laryngoplasty; Other: Sham of voice therapy; Behavioral: Voice therapy; Other: Sham of injection

• Study Type: Interventional
• Enrollment (Anticipated): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Cliniques Universitaires St Luc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Injection laryngoplasty group (IL); 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; Hyaluronic acid is injected into the paralyzed vocal fold; Other: Sham of voice therapy; 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.
Experimental: Voice therapy group (VT); 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; 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; Other: Sham of injection; Injection of physiological saline under the skin of the neck (sham of injection).
Sham Comparator: Sham group; 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 voice therapy; 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.; Other: Sham of injection; Injection of physiological saline under the skin of the neck (sham of injection).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Anticipated): September 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: March 29, 2019
• First Submitted That Met QC Criteria: April 5, 2019
• First Posted (Actual): April 8, 2019

Study Record Updates

• Last Update Posted (Actual): May 26, 2022
• Last Update Submitted That Met QC Criteria: May 19, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Cranial Nerve Diseases; Laryngeal Diseases; Vagus Nerve Diseases; Paralysis; Vocal Cord Paralysis; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: 2018/03OCT/365

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No