Early UVFP Management Based on Neurological Evidences UVFP = Unilateral Vocal Fold Paralysis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Unilateral Vocal Cord Paralysis
- Sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de Louvain
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Recovery of the vocal fold mobility
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Recovery of the vocal fold mobility
Time Frame: 9 to 12 months after paralysis
Videostroboscopy examination to analyse vocal folds movements in three dimensions
Central auditory processes
Time Frame: Within 3 months after paralysis
Auditory perception tasks performed using an audio headset
Laryngeal recurrent nerve reinnervation
Time Frame: 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
Time Frame: 9 to 12 months after paralysis
Functional magnetic resonance imaging examination (tomodensitometry and connectivity)
Voice recovery
Time Frame: 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)