Early UVFP Management Based on Neurological Evidences (UVFP = Unilateral Vocal Fold Paralysis)
NCT ID: NCT03906877
Last Updated: 2023-11-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
6 participants
INTERVENTIONAL
2019-11-15
2023-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Injection laryngoplasty group (IL)
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.
Acid hyaluronic injection laryngoplasty
Hyaluronic acid is injected into the paralyzed vocal fold
Sham 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.
Voice therapy group (VT)
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
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
Sham of injection
Injection of physiological saline under the skin of the neck (sham of injection).
Sham group
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.
Sham of injection
Injection of physiological saline under the skin of the neck (sham of injection).
Sham 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Acid hyaluronic injection laryngoplasty
Hyaluronic acid is injected into the paralyzed vocal fold
Voice 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
Sham of injection
Injection of physiological saline under the skin of the neck (sham of injection).
Sham 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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.
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Gauthier Desuter
Role: PRINCIPAL_INVESTIGATOR
SSS/MEDE and SSS/IONS/NEUR
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cliniques Universitaires St Luc
Brussels, , Belgium
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018/03OCT/365
Identifier Type: -
Identifier Source: org_study_id