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Clinical Trials/NCT03966183
NCT03966183
Completed
Not Applicable

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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 site in 1 country40 target enrollmentJune 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Unilateral Vocal Cord Paralysis
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Enrollment
40
Locations
1
Primary Endpoint
Central auditory processes
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 15, 2019
End Date
September 30, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Responsible Party
Sponsor

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.

Outcomes

Primary Outcomes

Central auditory processes

Time Frame: Min 3 months post thyroplasty

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)

Voice quality

Time Frame: Min 3 months post thyroplasty

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)

Changes in the neuronal pathways involved in the processing of the auditory inputs

Time Frame: Max 6 months after involvement in the study

Functional magnetic resonance imaging examination (tomodensitometry and connectivity)

Study Sites (1)

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