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出境医 / 临床实验 / Early UVFP Management Based on Neurological Evidences (ION-UVFP) - Preliminary Study

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

Study Description
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.

Condition or disease
Unilateral Vocal Cord Paralysis Central Auditory Processing Disorder

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.

Study Design
Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Early UVFP Management Based on Neurological Evidences (UVFP = Unilateral Vocal Fold Paralysis) (ION-UVFP) - Preliminary Study
Actual Study Start Date : June 15, 2019
Estimated Primary Completion Date : September 30, 2023
Estimated Study Completion Date : September 30, 2023
Arms and Interventions
Group/Cohort
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.
Outcome Measures
Primary Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Criteria

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.
Contacts and Locations

Contacts
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Contact: Marie Dedry +32 10 47 43 81 marie.dedry@uclouvain.be
Contact: Gauthier Desuter +32 764 13 55 gauthier.desuter@uclouvain.be

Locations
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Belgium
Cliniques Universitaires St Luc Recruiting
Brussels, Belgium, 1200
Contact: Gauthier Desuter, MD         
Sponsors and Collaborators
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Investigators
Layout table for investigator information
Principal Investigator: Gauthier Desuter SSS/MEDE and SSS/IONS/NEUR
Tracking Information
First Submitted Date May 27, 2019
First Posted Date May 29, 2019
Last Update Posted Date October 22, 2020
Actual Study Start Date June 15, 2019
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 27, 2019)
  • 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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Early UVFP Management Based on Neurological Evidences (ION-UVFP) - Preliminary Study
Official Title Early UVFP Management Based on Neurological Evidences (UVFP = Unilateral Vocal Fold Paralysis) (ION-UVFP) - Preliminary Study
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 6 Months
Biospecimen Not Provided
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
Condition
  • Unilateral Vocal Cord Paralysis
  • Central Auditory Processing Disorder
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 27, 2019)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 30, 2023
Estimated Primary Completion Date September 30, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Marie Dedry +32 10 47 43 81 marie.dedry@uclouvain.be
Contact: Gauthier Desuter +32 764 13 55 gauthier.desuter@uclouvain.be
Listed Location Countries Belgium
Removed Location Countries  
 
Administrative Information
NCT Number NCT03966183
Other Study ID Numbers 2018/03OCT/365 - (1)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study Sponsor Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators Not Provided
Investigators
Principal Investigator: Gauthier Desuter SSS/MEDE and SSS/IONS/NEUR
PRS Account Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Verification Date October 2020