Unilateral Vocal Cord ParalysisIONS-UVFPNCT03906877
Early UVFP Management Based on Neurological Evidences (UVFP = Unilateral Vocal Fold Paralysis)
A study testing Acid hyaluronic injection laryngoplasty and Voice therapy in people with Unilateral Vocal Cord Paralysis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Unilateral Vocal Cord Paralysis
- What is being tested?
- Acid hyaluronic injection laryngoplasty and Voice therapy
- Type of treatment
- Injection or infusion, Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 6 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Nov 2019to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Unilateral paralysis in abduction of the vocal cords may be included in the study.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early UVFP Management Based on Neurological Evidences UVFP = Unilateral Vocal Fold Paralysis
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.
- Conditions
- Unilateral Vocal Cord Paralysis
- Being tested
- Acid hyaluronic injection laryngoplasty, Voice therapy, Sham of injection, Sham of voice therapy
- Medical subject headings
- Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acid hyaluronic injection laryngoplastyProcedure or surgery
Hyaluronic acid is injected into the paralyzed vocal fold
Voice therapyBehavioural
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 injectionOther
Injection of physiological saline under the skin of the neck (sham of injection).
Sham of voice therapyOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Injection laryngoplasty group (IL) | Experimental | 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. Receives: Procedure: Acid hyaluronic injection laryngoplasty; Other: Sham of voice therapy |
| Voice therapy group (VT) | Experimental | 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). Receives: Behavioral: Voice therapy; Other: Sham of injection |
| Sham group | Sham comparator | 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. Receives: Other: Sham of injection; Other: Sham of voice therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laryngeal recurrent nerve reinnervation
Defined through qualitative laryngeal electromyography
Measured: 9 to 12 months after paralysis
Recovery of the vocal fold mobility
Videostroboscopy examination to analyse vocal folds movements in three dimensions
Measured: 9 to 12 months after paralysis
Voice recovery
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)
Measured: 9 to 12 months after paralysis
Changes in the neuronal pathways involved in the processing of the proprioceptive and auditory inputs
Functional magnetic resonance imaging examination (tomodensitometry and connectivity)
Measured: 9 to 12 months after paralysis
Central auditory processes
Auditory perception tasks performed using an audio headset
Measured: Within 3 months after paralysis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start15 Nov 2019
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Vocal Cord ParalysisStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gauthier Desuter, Principal investigator, SSS/MEDE and SSS/IONS/NEUR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03906877
- Sponsor's protocol ID
- 2018/03OCT/365
- Acronym
- IONS-UVFP
- Status last verified
- Nov 2023
- First submitted
- 29 Mar 2019
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early UVFP Management Based on Neurological Evidences UVFP = Unilateral Vocal Fold Paralysis
- ClinicalTrials.gov ID
- NCT03906877
- Acronym / sponsor ID
- IONS-UVFP / 2018/03OCT/365
- Conditions
- Unilateral Vocal Cord Paralysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Injection laryngoplasty group (IL) | Experimental | Procedure: Acid hyaluronic injection laryngoplasty, Other: Sham of voice therapyThe 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) | Experimental | Behavioral: Voice therapy, Other: Sham of injectionPatients 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). |
| Sham group | Sham comparator | Other: Sham of injection, Other: Sham of voice therapyThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Unilateral paralysis in abduction of the vocal cords may be included in the study.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acid hyaluronic injection laryngoplastyHyaluronic acid is injected into the paralyzed vocal fold | Procedure or surgery | Injection laryngoplasty group (IL) |
| Voice therapy15 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 | Behavioural | Voice therapy group (VT) |
| Sham of injectionInjection of physiological saline under the skin of the neck (sham of injection). | Other | Sham group, Voice therapy group (VT) |
| Sham of voice therapy15 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. | Other | Injection laryngoplasty group (IL), Sham group |
Primary outcome
Laryngeal recurrent nerve reinnervation
Time frame: 9 to 12 months after paralysis
Defined through qualitative laryngeal electromyography
Recovery of the vocal fold mobility
Time frame: 9 to 12 months after paralysis
Videostroboscopy examination to analyse vocal folds movements in three dimensions
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)
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)
Central auditory processes
Time frame: Within 3 months after paralysis
Auditory perception tasks performed using an audio headset
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Unilateral Vocal Cord Paralysis
Not yet recruiting
Recurrent Laryngeal Nerve Monitoring During Pediatric Aerodigestive Tract and Cardiac Surgery
Unilateral Vocal Cord Paralysis, Unilateral Vocal Cord Paresis
Enrolling by invitationObservational study
Outcomes Tracking in Unilateral Vocal Fold Paralysis (UVFP) and Atrophy After Medialization Laryngeal Surgery
Unilateral Vocal Cord Paralysis, Vocal Cord Atrophy
Active, not recruiting
Performance of the SPIRION Laryngeal Pacemaker in BVFP Patients Without Glottal Enlargement
Bilateral Vocal Cord Paralysis
Recruiting
APrevent-VOIS-Implant-002 - a Two-Part, Open-Label, Non-Randomized Multicenter Study
Paralysis, Unilateral, Vocal Cord
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gauthier Desuter principal investigator
SSS/MEDE and SSS/IONS/NEUR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acid hyaluronic injection laryngoplasty and Voice therapy in people with Unilateral Vocal Cord Paralysis, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Laryngeal recurrent nerve reinnervation (time frame: 9 to 12 months after paralysis). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2023.