Early UVFP Management Based on Neurological Evidences (UVFP = Unilateral Vocal Fold Paralysis)
- Conditions
- Unilateral Vocal Cord Paralysis
- Interventions
- Other: Sham of injectionProcedure: Acid hyaluronic injection laryngoplastyBehavioral: Voice therapyOther: Sham of voice therapy
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 6
- Unilateral paralysis in abduction of the vocal cords may be included in the study.
- 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
- Arm && Interventions
Group Intervention Description Sham group Sham of voice therapy 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. Injection laryngoplasty group (IL) Sham of voice therapy 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. Sham group 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. Injection laryngoplasty group (IL) Acid hyaluronic injection laryngoplasty 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. Voice therapy group (VT) Voice therapy 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). Voice therapy group (VT) Sham of injection 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).
- 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Cliniques Universitaires St Luc
🇧🇪Brussels, Belgium