Skip to main content
OpenTrials
Completed

NCT Number: NCT03906877

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires St Luc

Brussels, 1200, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Acid hyaluronic injection laryngoplasty

Procedure

Hyaluronic acid is injected into the paralyzed vocal fold

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

Sham of injection

Other

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

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.

Primary outcomes

  1. Laryngeal recurrent nerve reinnervation

    Time frame: 9 to 12 months after paralysis

    Defined through qualitative laryngeal electromyography

  2. Recovery of the vocal fold mobility

    Time frame: 9 to 12 months after paralysis

    Videostroboscopy examination to analyse vocal folds movements in three dimensions

  3. Voice recovery

    Time frame: 9 to 12 months after paralysis

    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)

  4. Changes in the neuronal pathways involved in the processing of the proprioceptive and auditory inputs

    Time frame: 9 to 12 months after paralysis

    Functional magnetic resonance imaging examination (tomodensitometry and connectivity)

  5. Central auditory processes

    Time frame: Within 3 months after paralysis

    Auditory perception tasks performed using an audio headset

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Acronym: IONS-UVFP

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 8, 2019
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.