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

Unilateral Vocal Cord Paralysis Clinical Trial

— IONS-UVFP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03906877
• Other study ID #: 2018/03OCT/365
• Status: Completed
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2023
• Source: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Paralysis
• Unilateral Vocal Cord Paralysis
• Vocal Cord Paralysis

Intervention

Procedure:
• Acid hyaluronic injection laryngoplasty
Hyaluronic acid is injected into the paralyzed vocal fold

Behavioral:
• Voice therapy
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

Other:
• Sham of injection
Injection of physiological saline under the skin of the neck (sham of injection).
• Sham of voice therapy
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.

Locations

Country	Name	City	State
Belgium	Cliniques Universitaires St Luc	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Laryngeal recurrent nerve reinnervation	Defined through qualitative laryngeal electromyography	9 to 12 months after paralysis
Primary	Recovery of the vocal fold mobility	Videostroboscopy examination to analyse vocal folds movements in three dimensions	9 to 12 months after paralysis
Primary	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)	9 to 12 months after paralysis
Primary	Changes in the neuronal pathways involved in the processing of the proprioceptive and auditory inputs	Functional magnetic resonance imaging examination (tomodensitometry and connectivity)	9 to 12 months after paralysis
Primary	Central auditory processes	Auditory perception tasks performed using an audio headset	Within 3 months after paralysis