Early UVFP Management Based on Neurological Evidences (ION-UVFP) - Preliminary Study

Early UVFP Management Based on Neurological Evidences (UVFP = Unilateral Vocal Fold Paralysis) (ION-UVFP) - Preliminary Study

The purpose of this preliminary study is to help clarify our hypotheses for the longitudinal study by investigating the relationship between vocal cord paralysis and central auditory processes and thus the interpretation of auditory inputs into the central nervous system.

Study Overview

• Status: Recruiting
• Conditions: Unilateral Vocal Cord Paralysis; Central Auditory Processing Disorder

Detailed Description

A very recent study (Naunheim et al., 2018) shows that paralysis of a vocal cord can affect central auditory processes, which in turn would have a negative impact on motor control capabilities during voice production. This study was conducted in patients who had undergone Type I thyroplasty. To highlight these influences, the authors relied on behavioral tests of auditory perception and vocal production.

The investigators would like in this study, based on a similar and existing population at the Cliniques Universitaires Saint-Luc, to try to understand the changes observed clinically by proposing to perform vocal production tasks (also planned for the longitudinal study) in the MRI. The investigators would like to objectify the differences in the areas involved in the central auditory processes in comparison between patients and control subjects.

• Study Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

• Study Contact: Name: Marie Dedry; Phone Number: +32 10 47 43 81; Email: marie.dedry@uclouvain.be
• Study Contact Backup: Name: Gauthier Desuter; Phone Number: +32 764 13 55; Email: gauthier.desuter@uclouvain.be

Study Locations

• Belgium
  • Brussels, Belgium, 1200
    • Recruiting
    • Cliniques Universitaires St Luc
    • Contact: Gauthier Desuter, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

• Patients who undergone type I thyroplasty (with Montgomery implant) at least 3 months ago after unilateral vocal fold paralysis
• Control participants without voice disorder

Description

Inclusion Criteria:

• Unilateral paralysis in abduction of the vocal cords may be included in the study.
• Patients who undergone type I thyroplasty (with Montgomery implant) at least 3 months ago
• Control participants without voice disorder

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?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
UVFP patients post thyroplasty; Patients in this group are adults who have undergone type I medialization thyroplasty (with Montgomery implant, silicone implant, follow-up of more than 3 months) as a definitive procedure following unilateral vocal fold paralysis.
Control participants; The people in this group are control subjects of the same age, sex and manual laterality as the patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Voice quality	Multidimensional voice assessment (Anamnestic interview, Maximum Phonation Time, Mean Air Flow, Mean subglottic pressure, Jitter, Shimmer, Noise-to-harmonic ratio, phonetogram, smoothed cepstral peak prominence, Voice Handicap Index - VHI-30, SF-36, EAT-10, GRBAS-I, Acoustic Voice Quality Index, Dysphonia Severity Index, Tonal and vocal audiometries)	Min 3 months post thyroplasty
Changes in the neuronal pathways involved in the processing of the auditory inputs	Functional magnetic resonance imaging examination (tomodensitometry and connectivity)	Max 6 months after involvement in the study
Central auditory processes	Auditory perception tasks performed using an audio headset (sound detection in noise, localization of a sound source, dichotic listening test, masking test, duration and frequency pattern test)	Min 3 months post thyroplasty

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 15, 2019
• Primary Completion (ANTICIPATED): September 30, 2023
• Study Completion (ANTICIPATED): September 30, 2023

Study Registration Dates

• First Submitted: May 27, 2019
• First Submitted That Met QC Criteria: May 27, 2019
• First Posted (ACTUAL): May 29, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 20, 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: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Otorhinolaryngologic Diseases; Ear Diseases; Cognition Disorders; Cranial Nerve Diseases; Language Disorders; Communication Disorders; Perceptual Disorders; Laryngeal Diseases; Vagus Nerve Diseases; Retrocochlear Diseases; Auditory Diseases, Central; Paralysis; Vocal Cord Paralysis; Language Development Disorders; Auditory Perceptual Disorders
• Other Study ID Numbers: 2018/03OCT/365 - (1)

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