Unilateral Vocal Cord Paralysis
Conditions
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.
Interventions
PROCEDUREAcid hyaluronic injection laryngoplasty
Hyaluronic acid is injected into the paralyzed vocal fold
BEHAVIORALVoice 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
OTHERSham of injection
Injection of physiological saline under the skin of the neck (sham of injection).
OTHERSham 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.
Sponsors
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Laryngeal recurrent nerve reinnervation | 9 to 12 months after paralysis | Defined through qualitative laryngeal electromyography |
| Recovery of the vocal fold mobility | 9 to 12 months after paralysis | Videostroboscopy examination to analyse vocal folds movements in three dimensions |
| 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) |
| 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) |
| Central auditory processes | Within 3 months after paralysis | Auditory perception tasks performed using an audio headset |
Countries
Belgium
Outcome results
None listed