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

NCT03906877 | Completed

• 1 other identifier: 2018/03OCT/365
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unilateral Vocal Cord Paralysis

Outcome Measures

Primary Outcomes (5)

• 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

Study Arms (3)

Injection laryngoplasty group (IL)

EXPERIMENTAL

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; Other: Sham of voice therapy

Voice therapy group (VT)

EXPERIMENTAL

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; Other: Sham of injection

Sham group

SHAM COMPARATOR

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; Other: Sham of voice therapy

Interventions

Acid hyaluronic injection laryngoplasty PROCEDURE

Hyaluronic acid is injected into the paralyzed vocal fold

Injection laryngoplasty group (IL)

Voice therapy BEHAVIORAL

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

Voice therapy group (VT)

Sham of injection OTHER

Injection of physiological saline under the skin of the neck (sham of injection).

Sham group; Voice therapy group (VT)

Sham of voice therapy OTHER

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.

Injection laryngoplasty group (IL); Sham group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Unilateral paralysis in abduction of the vocal cords may be included in the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Cliniques Universitaires St Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Vocal Cord Paralysis

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Gauthier Desuter

  SSS/MEDE and SSS/IONS/NEUR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 8, 2019
• Study Start: November 15, 2019
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)