Clinical trial NCT03966183: Early UVFP Management Based on Neurological Evidences (ION-UVFP) - Preliminary Study
Official title: Early UVFP Management Based on Neurological Evidences (UVFP = Unilateral Vocal Fold Paralysis) (ION-UVFP) - Preliminary Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Unilateral Vocal Cord Paralysis
Central Auditory Processing Disorder
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2019-05-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Voice quality
timeFrame: Min 3 months post thyroplasty
measure: Changes in the neuronal pathways involved in the processing of the auditory inputs
timeFrame: Max 6 months after involvement in the study
measure: Central auditory processes
timeFrame: Min 3 months post thyroplasty
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: Cliniques Universitaires St Luc
Study officials:
affiliation: SSS/MEDE and SSS/IONS/NEUR
name: Gauthier Desuter
role: PRINCIPAL_INVESTIGATOR
References: