Early UVFP Management Based on Neurological Evidences (UVFP = Unilateral Vocal Fold Paralysis) (IONS-UVFP)
Unilateral Vocal Cord Paralysis
About this trial
This is an interventional treatment trial for Unilateral Vocal Cord Paralysis
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.
- 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.
Sites / Locations
- Cliniques Universitaires St Luc
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Sham Comparator
Injection laryngoplasty group (IL)
Voice therapy group (VT)
Sham group
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.
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).
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.