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

NCT03966183 | Completed

• 1 other identifier: 2018/03OCT/365 - (1)
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Unilateral Vocal Cord Paralysis; Central Auditory Processing Disorder

Outcome Measures

Primary Outcomes (3)

• Voice quality

  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)

  Min 3 months post thyroplasty

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

  Functional magnetic resonance imaging examination (tomodensitometry and connectivity)

  Max 6 months after involvement in the study

• Central auditory processes

  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)

  Min 3 months post thyroplasty

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* Patients who undergone type I thyroplasty (with Montgomery implant) at least 3 months ago after unilateral vocal fold paralysis * Control participants without voice disorder

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques Universitaires St Luc

Brussels, 1200, Belgium

Location

MeSH Terms

Conditions

Vocal Cord Paralysis; Language Development Disorders

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Language Disorders; Communication Disorders; Neurobehavioral Manifestations

Study Officials

• Gauthier Desuter

  SSS/MEDE and SSS/IONS/NEUR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: May 29, 2019
• Study Start: June 15, 2019
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: November 24, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)