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

Not Applicable

Completed

• Conditions: Unilateral Vocal Cord Paralysis

• Registration Number: NCT03906877
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-29
• Study First Submitted QC: 2019-04-05
• Study First Posted: 2019-04-08
• Study Start: 2019-11-15
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-22
• Last Update Posted: 2023-11-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Trial Locations

Locations (1)

Cliniques Universitaires St Luc; 🇧🇪 Brussels, Belgium