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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03966183
Enrollment
40
Registered
2019-05-29
Start date
2019-06-15
Completion date
2023-09-30
Last updated
2023-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Auditory Processing Disorder, Unilateral Vocal Cord Paralysis

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.

Interventions

None listed

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Voice qualityMin 3 months post thyroplastyMultidimensional 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 inputsMax 6 months after involvement in the studyFunctional magnetic resonance imaging examination (tomodensitometry and connectivity)
Central auditory processesMin 3 months post thyroplastyAuditory 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)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026