May 27, 2019
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May 29, 2019
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October 22, 2020
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June 15, 2019
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September 30, 2023 (Final data collection date for primary outcome measure)
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- 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)
- 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)
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Same as current
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Not Provided
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Not Provided
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Not Provided
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Not Provided
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Early UVFP Management Based on Neurological Evidences (ION-UVFP) - Preliminary Study
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Early UVFP Management Based on Neurological Evidences (UVFP = Unilateral Vocal Fold Paralysis) (ION-UVFP) - Preliminary Study
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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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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.
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Observational [Patient Registry]
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Observational Model: Cohort Time Perspective: Prospective
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6 Months
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Not Provided
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Non-Probability Sample
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- Patients who undergone type I thyroplasty (with Montgomery implant) at least 3 months ago after unilateral vocal fold paralysis
- Control participants without voice disorder
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- Unilateral Vocal Cord Paralysis
- Central Auditory Processing Disorder
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Not Provided
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- UVFP patients post thyroplasty
Patients in this group are adults who have undergone type I medialization thyroplasty (with Montgomery implant, silicone implant, follow-up of more than 3 months) as a definitive procedure following unilateral vocal fold paralysis.
- Control participants
The people in this group are control subjects of the same age, sex and manual laterality as the patients.
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Not Provided
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Recruiting
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40
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Same as current
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September 30, 2023
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September 30, 2023 (Final data collection date for primary outcome measure)
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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.
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Sexes Eligible for Study: |
All |
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18 Years and older (Adult, Older Adult)
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Yes
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Contact: Marie Dedry |
+32 10 47 43 81 |
marie.dedry@uclouvain.be |
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Contact: Gauthier Desuter |
+32 764 13 55 |
gauthier.desuter@uclouvain.be |
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Belgium
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NCT03966183
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2018/03OCT/365 - (1)
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No
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Studies a U.S. FDA-regulated Drug Product: |
No |
Studies a U.S. FDA-regulated Device Product: |
No |
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Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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Not Provided
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Principal Investigator: |
Gauthier Desuter |
SSS/MEDE and SSS/IONS/NEUR |
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Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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October 2020
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