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NCT Number: NCT03966183

Early UVFP Management Based on Neurological Evidences (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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 29, 2019
Registry last updated
Nov 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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