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

Unilateral Vocal Cord Paralysis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03966183
• Other study ID #: 2018/03OCT/365 - (1)
• Status: Completed
• Start date: June 15, 2019
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2023
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Auditory Perceptual Disorders
• Central Auditory Processing Disorder
• Language Development Disorders
• Paralysis
• Unilateral Vocal Cord Paralysis
• Vocal Cord Paralysis

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires St Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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