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

  • STATUS
    Recruiting
  • End date
    Sep 30, 2023
  • participants needed
    40
  • sponsor
    Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Updated on 4 June 2022
Accepts healthy volunteers

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.

Details
Condition Unilateral Vocal Cord Paralysis, Central Auditory Processing Disorder
Clinical Study IdentifierNCT03966183
SponsorCliniques universitaires Saint-Luc- Université Catholique de Louvain
Last Modified on4 June 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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