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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-06-15

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Unilateral Vocal Cord Paralysis Central Auditory Processing Disorder

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Control participants

The people in this group are control subjects of the same age, sex and manual laterality as the patients.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gauthier Desuter

Role: PRINCIPAL_INVESTIGATOR

SSS/MEDE and SSS/IONS/NEUR

Locations

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Cliniques Universitaires St Luc

Brussels, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2018/03OCT/365 - (1)

Identifier Type: -

Identifier Source: org_study_id

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