Paralysis, Unilateral, Vocal CordNCT02163772
Early Intracordal Hyaluronic Acid Injection During Spontaneous Reinnervation for Unilateral Recurrent Laryngeal Nerve Paralysis
A study testing Intracordal hyaluronate injection in people with Paralysis, Unilateral, Vocal Cord, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Backgrounds: Unilateral vocal cord paralysis caused from recurrent laryngeal nerve (RLN) injury is not an unusual disease and may deteriorate patients'voice and swallowing outcomes. Although the long term treatment effect is encouraged, the point when to perform surgical treatment is not conclusive. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paralysis, Unilateral, Vocal Cord
- What is being tested?
- Intracordal hyaluronate injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2011to Jul 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients of untreated unilateral vocal cord paralysis with a known cause of RLN injury within 3-6 month will be enrolled
Who cannot join
- Patients proved to be not suitable for transcutaneous intracordal injection under topical anesthesia. Those who had previous phonosurgery or can't follow the observation rule will also be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Backgrounds: Unilateral vocal cord paralysis caused from recurrent laryngeal nerve (RLN) injury is not an unusual disease and may deteriorate patients'voice and swallowing outcomes. Although the long term treatment effect is encouraged, the point when to perform surgical treatment is not conclusive. Previous reports suggested late treatment principle because patients may spontaneous reinnervation to some degree within 4-5 months after injury. The vocal cord position and tone may change during reinnervation. Others delineated laryngeal synkinesis by misdirected reinnervation is common and suggested early temporary injection laryngoplasty. They implied early injection laryngoplasty may improve patients'not only short term voice outcomes but also decrease the incidence of transcervical laryngeal framework surgery as a determined surgery. However, lacking of prospective study and objective data makes the treatment-time policy still controversial. Purposes: 1. To find incidence of spontaneous reinnervation or synkinetic regeneration. 2. To detect the relationship between changing of glottal gap and laryngeal synkinesis. 3. To detect the impaction of early intracordal hyaluronic acid injection on vocal cord position change in patients with laryngeal synkinesis. Study design: Forty patients is planned to be enrolled in the study. Twenty of them will undergo hyaluronate intracordal injection at three-six month from RLN damage. The other 20 patients will follow the watch-and wait policy. Laryngoscope, laryngeal EMG (electromyography), voice analysis and voice outcome survey will be done at 3-6 month and 12-month after RLN injury. At the end of follow up, the glottal gap, voice laboratory data and quality of life will be compared. The outcomes will also be correlated with laryngeal electromyography (LEMG) data and the impact of synkinetic reinnervation.
- Conditions
- Paralysis, Unilateral, Vocal Cord
- Being tested
- Intracordal hyaluronate injection
- 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.
Intracordal hyaluronate injectionProcedure or surgery
Also called Resylane
| Study group | Role | What they receive |
|---|---|---|
| Intracordal hyaluronate injection (HI) | Experimental | The intervention of Intracordal hyaluronate (Restylane) injection is given in this group No other therapies are given Receives: Procedure: Intracordal hyaluronate injection |
| Conservative management (CM) | No intervention | In this arm, only observation is arranged. No therapy is given. |
What is being measured
The primary outcome is the main question the study is designed to answer.
voice outcome
VOS score: The VOS originally developed by Gliklich et al. comprises a five-item survey that evaluates the physical and social problems associated with unilateral vocal fold palsy.
Measured: before intervention and at 6 month follow-up
Secondary outcomes (4)
laryngeal electromyography
laryngeal electromyography signals were obtained using a concentric needle electrode with the surface-ground electrode adhered to the forehead. We examined the electromyography signals on bilateral thyroarytenoid muscle and cricothyroid muscles. With the concentric needle electrode in the thyroarytenoid muscle , the patient was asked to produce three series of "e"s at three different intensities (low, moderate and highest possible), with each "e" lasting at least 400 ms and each inter-"e" interval lasting about 200 ms. To evaluate cricothyroid function, the patients were asked to produce a glissando upward "e" at normal loudness.
Measured: before and 6 months post intervention
videolaryngostroboscopy
An image of glottis was captured during the videolaryngoscopy examination while the patient vocalized /eee/ at modal pitch and regular loudness. The images showing the narrowest vocal slitglottal gap from several phonatory cycles were measured.
Measured: before and 6 months post intervention
laboratory voice analysis
In a sound-insulated room, the patient read a standard passage and a sustained vowel at a conversational pitch and loudness. The patient's voice was captured using a unidirectional dynamic microphone (Shure SM48; Shure Brothers Inc., Agua Prieta, Mexico).
Measured: before and 6 months post intervention
health related quality of life (SF-36)
The SF-36 questionnaire is designed for general health measurement of 8 domains, including physical functioning, role functioning-physical problems, bodily pain, general health, vitality, social functioning, role functioning-emotional problems, and mental health. The recall period of SF-36 is 4 weeks.
Measured: before and 6 months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2014 (estimated)
- Study startAug 2011
- Primary completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paralysis, Unilateral, Vocal CordStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe 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
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163772
- Sponsor's protocol ID
- NSC100-2314-B-182-021
- Status last verified
- Jul 2013
- First submitted
- 10 Jun 2014
- Last updated
- 16 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Pei YC, Fang TJ, Hsin LJ, Li HY, Wong AM. Early hyaluronate injection improves quality of life but not neural recovery in unilateral vocal fold paralysis: an open-label randomized controlled study. Restor Neurol Neurosci. 2015;33(2):121-30. doi: 10.3233/RNN-140439.
PubMed 25588457
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Intracordal Hyaluronic Acid Injection During Spontaneous Reinnervation for Unilateral Recurrent Laryngeal Nerve Paralysis
- ClinicalTrials.gov ID
- NCT02163772
- Acronym / sponsor ID
- NSC100-2314-B-182-021
- Conditions
- Paralysis, Unilateral, Vocal Cord
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Aug 2011
- Primary completion
- Jul 2013 (actual)
- First posted
- 16 Jun 2014 (estimated)
- 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.
Backgrounds: Unilateral vocal cord paralysis caused from recurrent laryngeal nerve (RLN) injury is not an unusual disease and may deteriorate patients'voice and swallowing outcomes. Although the long term treatment effect is encouraged, the point when to perform surgical treatment is not conclusive. Previous reports suggested late treatment principle because patients may spontaneous reinnervation to some degree within 4-5 months after injury. The vocal cord position and tone may change during reinnervation. Others delineated laryngeal synkinesis by misdirected reinnervation is common and suggested early temporary injection laryngoplasty. They implied early injection laryngoplasty may improve patients'not only short term voice outcomes but also decrease the incidence of transcervical laryngeal framework surgery as a determined surgery. However, lacking of prospective study and objective data makes the treatment-time policy still controversial. Purposes: 1. To find incidence of spontaneous reinnervation or synkinetic regeneration. 2. To detect the relationship between changing of glottal gap and laryngeal synkinesis. 3. To detect the impaction of early intracordal hyaluronic acid injection on vocal cord position change in patients with laryngeal synkinesis. Study design: Forty patients is planned to be enrolled in the study. Twenty of them will undergo hyaluronate intracordal injection at three-six month from RLN damage. The other 20 patients will follow the watch-and wait policy. Laryngoscope, laryngeal EMG (electromyography), voice analysis and voice outcome survey will be done at 3-6 month and 12-month after RLN injury. At the end of follow up, the glottal gap, voice laboratory data and quality of life will be compared. The outcomes will also be correlated with laryngeal electromyography (LEMG) data and the impact of synkinetic reinnervation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intracordal hyaluronate injection (HI) | Experimental | Procedure: Intracordal hyaluronate injectionThe intervention of Intracordal hyaluronate (Restylane) injection is given in this group No other therapies are given |
| Conservative management (CM) | No intervention | –In this arm, only observation is arranged. No therapy is given. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients of untreated unilateral vocal cord paralysis with a known cause of RLN injury within 3-6 month will be enrolled
Key exclusion criteria (1 listed)
- Patients proved to be not suitable for transcutaneous intracordal injection under topical anesthesia. Those who had previous phonosurgery or can't follow the observation rule will also be excluded.
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 |
|---|---|---|
| Intracordal hyaluronate injectionAlso: Resylane | Procedure or surgery | Intracordal hyaluronate injection (HI) |
Primary outcome
voice outcome
Time frame: before intervention and at 6 month follow-up
VOS score: The VOS originally developed by Gliklich et al. comprises a five-item survey that evaluates the physical and social problems associated with unilateral vocal fold palsy.
4 secondary outcomes
laryngeal electromyography
Time frame: before and 6 months post intervention
videolaryngostroboscopy
Time frame: before and 6 months post intervention
laboratory voice analysis
Time frame: before and 6 months post intervention
health related quality of life (SF-36)
Time frame: before and 6 months post intervention
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 16 Jun 2014.
- Derived from this study: PubMed 25588457Pei YC, Fang TJ, Hsin LJ, Li HY, Wong AM. Early hyaluronate injection improves quality of life but not neural recovery in unilateral vocal fold paralysis: an open-label randomized controlled study. Restor Neurol Neurosci. 2015;33(2):121-30. doi: 10.3233/RNN-140439.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intracordal hyaluronate injection in people with Paralysis, Unilateral, Vocal Cord, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 1 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 16 Jun 2014. 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 Taiwan. 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. 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?
voice outcome (time frame: before intervention and at 6 month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02163772, which also lists 1 linked publication.
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 16 Jun 2014.