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Early UVFP Management Based on Neurological Evidences (UVFP = Unilateral Vocal Fold Paralysis) (IONS-UVFP)

Primary Purpose

Unilateral Vocal Cord Paralysis

Status
Active
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Acid hyaluronic injection laryngoplasty
Voice therapy
Sham of injection
Sham of voice therapy
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Unilateral Vocal Cord Paralysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

- Unilateral paralysis in abduction of the vocal cords may be included in the study.

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.

Sites / Locations

  • Cliniques Universitaires St Luc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Sham Comparator

Arm Label

Injection laryngoplasty group (IL)

Voice therapy group (VT)

Sham group

Arm Description

The patients in the first group will receive an IL of hyaluronic acid in the paralyzed vocal fold within a maximum of three months after the onset of symptoms. The Ear-Noise-Throat (ENT) physician will perform the injection in office, under topical anaesthesia.

Patients from the second group will be involved in 15 sessions of thirty minutes of voice therapy, twice a week, and will have to do home practice. Patients will have to record these training sessions. Initiation of this intervention should also take place within the first three months after the onset of symptoms. They will also receive an injection of physiological saline under the skin of the neck (sham of injection).

The patients of the third group will be treated following the traditional wait-and-see policy. They will receive an injection of physiological saline under the skin of the neck and will be seen during 15 sessions of 30 minutes, twice a week. Therefore, this will be a sham procedure for both IL and VT.

Outcomes

Primary Outcome Measures

Laryngeal recurrent nerve reinnervation
Defined through qualitative laryngeal electromyography
Recovery of the vocal fold mobility
Videostroboscopy examination to analyse vocal folds movements in three dimensions
Voice recovery
Multidimensional voice assessment (based on anamnestic interview, Maximum Phonation Time in sec, Mean Air Flow in ml/sec, Mean subglottic pressure in cmH2O, Jitter in %, Shimmer in %, Noise-to-harmonic ratio, phonetogram, smoothed cepstral peak prominence in %, Voice Handicap Index - VHI-30 (*total* : 0-120, higher value = worse outcome), Medical Outcomes Study 36-item Short Form Healthy Survey (*8 subscales* : 0-100, higher value = better outcome, Eating Assessment Tool-10 (*total*: 0-40, higher value = worse outcome), GRBAS-I (*6 subscales* : 0-3, higher value = worse outcome), Acoustic Voice Quality Index, Dysphonia Severity Index (DSI = 0.13 x MPT + 0.0053 x F(0)-High - 0.26 x I-Low - 1.18 x Jitter (%) + 12.4),Tonal and vocal audiometries in dB)
Changes in the neuronal pathways involved in the processing of the proprioceptive and auditory inputs
Functional magnetic resonance imaging examination (tomodensitometry and connectivity)
Central auditory processes
Auditory perception tasks performed using an audio headset

Secondary Outcome Measures

Full Information

First Posted
March 29, 2019
Last Updated
May 19, 2022
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
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1. Study Identification

Unique Protocol Identification Number
NCT03906877
Brief Title
Early UVFP Management Based on Neurological Evidences (UVFP = Unilateral Vocal Fold Paralysis)
Acronym
IONS-UVFP
Official Title
Early UVFP Management Based on Neurological Evidences UVFP = Unilateral Vocal Fold Paralysis
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 15, 2019 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of this study is to understand how early intervention could impact reinnervation of the recurrent laryngeal nerve (which innervates the vocal cord), recovery of mobility of the paralyzed vocal cord and / or vocal recovery in the case of unilateral vocal fold paralysis. To achieve this goal we must therefore carry out a complete outcomes assessment of different intervention methods (voice therapy and injection laryngoplasty), which are offered to UVFP (unilateral vocal fold paralysis) patients in the early stage (< 3 months). Their respective impacts on the central and peripheral nervous system and on the voice quality will be assessed, taking into account factors related to the severity of the paralysis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Vocal Cord Paralysis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Injection laryngoplasty group (IL)
Arm Type
Experimental
Arm Description
The patients in the first group will receive an IL of hyaluronic acid in the paralyzed vocal fold within a maximum of three months after the onset of symptoms. The Ear-Noise-Throat (ENT) physician will perform the injection in office, under topical anaesthesia.
Arm Title
Voice therapy group (VT)
Arm Type
Experimental
Arm Description
Patients from the second group will be involved in 15 sessions of thirty minutes of voice therapy, twice a week, and will have to do home practice. Patients will have to record these training sessions. Initiation of this intervention should also take place within the first three months after the onset of symptoms. They will also receive an injection of physiological saline under the skin of the neck (sham of injection).
Arm Title
Sham group
Arm Type
Sham Comparator
Arm Description
The patients of the third group will be treated following the traditional wait-and-see policy. They will receive an injection of physiological saline under the skin of the neck and will be seen during 15 sessions of 30 minutes, twice a week. Therefore, this will be a sham procedure for both IL and VT.
Intervention Type
Procedure
Intervention Name(s)
Acid hyaluronic injection laryngoplasty
Intervention Description
Hyaluronic acid is injected into the paralyzed vocal fold
Intervention Type
Behavioral
Intervention Name(s)
Voice therapy
Intervention Description
15 sessions of thirty minutes of voice therapy, twice a week, and home practice. This voice management will be specific to unilateral vocal fold paralysis and will focus on three objectives: reinforcement of the vocal muscle, glottal closure and glottal opening. These three objectives will be worked through different vocal exercises (on voiced phonemes) and breathing exercises
Intervention Type
Other
Intervention Name(s)
Sham of injection
Intervention Description
Injection of physiological saline under the skin of the neck (sham of injection).
Intervention Type
Other
Intervention Name(s)
Sham of voice therapy
Intervention Description
15 sessions of thirty minutes of voice therapy, twice a week, and home practice. This voice management will not be specific to UVFP but may allow patients to improve their vocal gesture.
Primary Outcome Measure Information:
Title
Laryngeal recurrent nerve reinnervation
Description
Defined through qualitative laryngeal electromyography
Time Frame
9 to 12 months after paralysis
Title
Recovery of the vocal fold mobility
Description
Videostroboscopy examination to analyse vocal folds movements in three dimensions
Time Frame
9 to 12 months after paralysis
Title
Voice recovery
Description
Multidimensional voice assessment (based on anamnestic interview, Maximum Phonation Time in sec, Mean Air Flow in ml/sec, Mean subglottic pressure in cmH2O, Jitter in %, Shimmer in %, Noise-to-harmonic ratio, phonetogram, smoothed cepstral peak prominence in %, Voice Handicap Index - VHI-30 (*total* : 0-120, higher value = worse outcome), Medical Outcomes Study 36-item Short Form Healthy Survey (*8 subscales* : 0-100, higher value = better outcome, Eating Assessment Tool-10 (*total*: 0-40, higher value = worse outcome), GRBAS-I (*6 subscales* : 0-3, higher value = worse outcome), Acoustic Voice Quality Index, Dysphonia Severity Index (DSI = 0.13 x MPT + 0.0053 x F(0)-High - 0.26 x I-Low - 1.18 x Jitter (%) + 12.4),Tonal and vocal audiometries in dB)
Time Frame
9 to 12 months after paralysis
Title
Changes in the neuronal pathways involved in the processing of the proprioceptive and auditory inputs
Description
Functional magnetic resonance imaging examination (tomodensitometry and connectivity)
Time Frame
9 to 12 months after paralysis
Title
Central auditory processes
Description
Auditory perception tasks performed using an audio headset
Time Frame
Within 3 months after paralysis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Unilateral paralysis in abduction of the vocal cords may be included in the study. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gauthier Desuter
Organizational Affiliation
SSS/MEDE and SSS/IONS/NEUR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universitaires St Luc
City
Brussels
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

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Early UVFP Management Based on Neurological Evidences (UVFP = Unilateral Vocal Fold Paralysis)

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