Vocal Cord ParalysisPhase 4NCT04839276

Administration of Platelet-rich Fibrin to Autologous Fat Tissue in Injection Laryngoplasty for Vocal Cord Paralysis

A Phase 4 study testing Injection Laryngoplasty with Platelet-rich Fibrin and Autologous Fat and Injection Laryngoplasty with Autologous Fat in people with Vocal Cord Paralysis, run by Fakultas Kedokteran Universitas Indonesia at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The study tries to see the effect of using a combination of platelet-rich fibrin (PRF) and autologous fat as a filler for injection laryngoplasty procedures to treat unilateral adductor vocal cord paralysis. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Vocal Cord Paralysis
What is being tested?: Injection Laryngoplasty with Platelet-rich Fibrin and Autologous Fat and Injection Laryngoplasty with Autologous Fat
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteIndonesia
Study dates: 1 Jan 2018to 1 Feb 2019
Phase: Phase 4
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject is diagnosed with unilateral vocal cord paralysis in paramedian position or 3 months lateral onset without movement and mucosal waves of the vocal cords on videostroboscopy.
Willing to give consent

Who cannot join

Has a history of malignancy of the larynx or lung
Subject isn't able to undergo injection laryngoplasty procedure under general anesthesia
Subject with thrombositopenia

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

Fakultas Kedokteran Universitas Indonesia
Jakarta Pusat, DKI Jakarta, 10450

Other trials in Indonesia

About this study

Official title: The Effect of Administering Platelet-rich Fibrin to Autologous Fat Tissue in Injection Laryngoplasty for Unilateral Adductor Vocal Cord Paralysis

Read the detailed description

The vocal cord in humans is essential in producing voice used in communication and interaction between us. Vocal cord paralysis causes dysphonia, which interferes with communication, causing disruptions towards social activity and daily activities. One of the managements for vocal cord paralysis is medialisation and augmentation of the vocal cord through injection laryngoplasty. Autologous fat is one of the best fillers that can be used in this procedure, but it is highly absorbable and can be reabsorbed very quickly when injected to body tissues. Platelet Rich Fibrin (PRF) is a biomaterial consisting of growth factors that are thought to improve fat tissue longevity through increase of adipogenesis and angiogenesis. Improvement in fat longevity will improve clinical outcomes after laryngoplasty procedure potentially reducing number of repeated injections needed to achieve satisfactory resolution to vocal cord paralysis. The study evaluates a combination of PRF and autologous microlobular fat compared with autologous microlobular fat alone on laryngoplasty. Subjective evaluation was done by using Voice Handicap Index (VHI-30) questionnaire, while objective evaluation was conducted via computerized acoustic analysis/Multidimensional Voice Program (MDVP), videostroboscopy, and maximum phonation time.

Conditions: Vocal Cord Paralysis
Being tested: Injection Laryngoplasty with Platelet-rich Fibrin and Autologous Fat, Injection Laryngoplasty with Autologous Fat
Keywords: platelet-rich fibrin, vocal cord paralysis, dysphonia, injection laryngoplasty
Medical subject headings: Vocal Cord Paralysis, Dysphonia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Injection Laryngoplasty with Platelet-rich Fibrin and Autologous FatCombination product
Also called RegenKit PRP Tube (Regen Lab)
Injection Laryngoplasty with a combination of Platelet-rich Fibrin (PRF) and Autologous Fat. The PRF was made by taking 10 mL of peripheral blood from a healthy donor. Blood is then put inside the tube from the Regen lab kit. The tube was centrifuged with a force of 1,500 g (3000 rpm) for 5 minutes producing platelet-rich plasma (PRP). 4 mL of the aforementioned PRP was transferred to a 10 mL test tube, 1 M CaCl2 was added with a micropipette until final concentration of 25 mM was, reached producing PRF. Autologous fat harvested from the patient's abdomen was then mixed with the PRF solution to create the filler for injection laryngoplasty procedures. The injection procedures are done by placing the patient in a sniffing position followed by intraoral Kleinsasser laryngoscope insertion through the uvula, posterior pharyngeal wall, and epiglottis until the vocal cords are visible. Injection of the filler is then done to the paralyzed vocal cords.
Injection Laryngoplasty with Autologous FatProcedure or surgery
Also called Lipid Autograft
Injection Laryngoplasty with autologous microlobular fat harvested from the patient's abdominal fat. Lidocaine was infiltrated under the umbilicus and then an incision was made in the area followed by fat removal using scissors. The fat was cleaned with 0.9% NaCl solution and then sheared into microlobular form. The injection procedures are done by placing the patient in a sniffing position followed by intraoral Kleinsasser laryngoscope insertion through the uvula, posterior pharyngeal wall, and epiglottis until the vocal cords are visible. Injection of the filler is then done to the paralyzed vocal cords.

Study groups in NCT04839276
Study group	Role	What they receive
Injection Laryngoplasty with PRF and Autologous Fat	Experimental	Autologous microlobular fat is harvested from abdominal fat (area under the umbilical). 4 mL of microlobular fat is added to 4 mL of PRF and is smoothed by pushing it back and forth 15 times on a 2-tube 10 mL piston tube connected to a three-way connector. 3 mL of the mixture of fat and PRF is injected using a 12 G laryngoplasty syringe until medialization is achieved. Receives: Combination Product: Injection Laryngoplasty with Platelet-rich Fibrin and Autologous Fat
Injection Laryngoplasty with Autologous Fat	Active comparator	Autologous microlobular fat is harvested from abdominal fat (area under the umbilical). 4 mL of microlobular fat is mashed by pushing it back and forth 15 times in a container of 2 piston tubes (10 mL) connected to a three-way connector. The crushed fat is injected as much as 3 mL using a 12 G laryngoplasty syringe until medialization is achieved. Receives: Procedure: Injection Laryngoplasty with Autologous Fat

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Voice Handicap Index-30 (VHI-30) questionnaire score
The Voice Handicap Index Questionnaire-30 (VHI-30) is a subjective examination that can be used to assess the severity of voice disorders and their impact on social life. The VHI-30 categorizes handicaps into mild, moderate, and severe. This study assessed the VHI-30 score as a numerical scale so that the median value for the treatment and control groups can be obtained. The assessment was carried out based on the patient's perception by addressing complaints for each question (0 = never, 1 = almost never, 2 = sometimes, 3 = almost always, 4 = always). Patients with severe voice disorders will achieve a higher VHI-30 score. Interpretation of the total value of the VHI-30 includes mild disability values of 0 - 30; moderate disability of 31 - 60; and a severe disability of 61-120. Changes in VHI-30 score are recorded and statistically analysed.
Measured: Before injection, 1 week, 4 week, 8 week post-injection
Changes in Maximum Phonation Time
Maximum phonation time describes the quality of the strength of the vocal cords when oscillating. The calculation of the phonation time will represent objective assessment of voice. Changes in maximum phonation time are recorded and statistically analysed.
Measured: Before injection, 1 week, 4 week, 8 week post-injection
Changes in Average Fundamental Frequency (F0)
The Average Fundamental Frequency (F0) is a parameter in MDVP that represents the number of vocal cord vibration cycles in one second. The mean frequency ranges from 120 Hz for men and 200 Hz for women, but this is also influenced by age, smoking and accent language. The average fundamental frequency reflects the biochemical characteristics of the vocal cords when interacting with the air flow in its path, these biochemical properties are influenced by the structure of the larynx and muscle tone. Changes in F0 are recorded and statistically analysed.
Measured: Before injection, 1 week, 4 week, 8 week post-injection
Changes in Jitter and Shimmer
Jitter and Shimmer is a parameter in MDVP that represents variations that occur in the basic frequency. Jitter denotes the chaos of sound wave frequency caused by a lack of control over the vibration of the vocal cords. Shimmer shows the chaos of sound wave amplitude which is influenced by decreased resistance of the glottis and presence of mass lesions of the vocal cords, associated with inadequate adduction of the vocal cords and irregularity of the surface of the vocal cords. Presence of jitter and shimmer denotes that there are disruption in phonation quality caused by problems in vocal cords. Changes in jitter and shimmer are recorded and statistically analysed.
Measured: Before injection, 1 week, 4 week, 8 week post-injection
Changes in Noise to Harmonic Ratio (NHR)
NHR is a parameter in MDVP that represents ratio of non-harmonic and harmonic waves in a certain sound wave period. NHR describes the quality of the amount of noise in the sound. Inadequate closure of the vocal cords and periodic vibrations of the vocal cords cause excessive air flow as it passes through the vocal cords, causing turbulence and noise. Normal and periodic sound signals will have a small NHR, while dysphonia sound signals will have a large NHR value. Changes in NHR are recorded and statistically analysed.
Measured: Before injection, 1 week, 4 week, 8 week post-injection
Changes in Voice Turbulence Index (VTI)
VTI (Voice Turbulence Index) is a parameter in MDVP that represents the ratio between non-harmonic waves at high frequencies of 2800 - 5800 Hz and harmonic waves at frequencies of 70 - 4500 Hz. This parameter assesses the energy level of high frequency noise and is largely related to the turbulence of sound caused due to loss of adduction motion. This parameter also relates to variations in the frequency or amplitude of sound, where the turbulence of sound occurs due to changes in muscle control. Changes in VTI are recorded and statistically analysed.
Measured: Before injection, 1 week, 4 week, 8 week post-injection
Changes in Amplitude Tremor Intensity Index (ATRI)
ATRI is a parameter in MDVP that represents the mean ratio of the low frequency amplitude to the total amplitude of the sound being examined. This parameter indicates the stability and strength of the vocal cords during phonation. Changes in ATRI are recorded and statistically analysed.
Measured: Before injection, 1 week, 4 week, 8 week post-injection
Changes in Vocal Cord Closure Pattern
The closure pattern of the vocal cords is one of the parameters in videostroboscopy. This examination looks at the pattern and medial edge of the vocal cords when closed and insulated. Changes in Vocal Cord Closure Pattern are recorded and statistically analysed.
Measured: Before injection, 1 week, 4 week, 8 week post-injection
Changes in Amplitude
The amplitude is one of the parameters in videostroboscopy. Amplitude is the amount of horizontal movement of the vocal cords. The magnitude of the amplitude is assessed by dividing the horizontal line into 5 sections from medial to lateral of the vocal cords. Changes in amplitude are recorded and statistically analysed.
Measured: Before injection, 1 week, 4 week, 8 week post-injection
Changes in Mucosal Waves
The mucosal waves is one of the parameters in videostroboscopy. Mucosal waves are the movement of the vocal cords from an inferior to a superior direction following the glottic cycle on the vertical axis. Changes in mucosal waves are recorded and statistically analysed.
Measured: Before injection, 1 week, 4 week, 8 week post-injection
Changes in Vertical Level
The vertical level is a parameter of the vocal cords on videostroboscopy that describes the difference in the height of the vocal cords that meet and are seen in the medial of the vocal cords. Changes in vertical level are recorded and statistically analysed.
Measured: Before injection, 1 week, 4 week, 8 week post-injection
Changes in Supraglottic Activity
The supraglottic activity is one of the parameters in videostroboscopy. Supraglottic activity describes a narrowing of the supraglottic structure wherein one of them is a collapsed arytenoid. Changes in supraglottic activity are recorded and statistically analysed.
Measured: Before injection, 1 week, 4 week, 8 week post-injection
Changes in Non-vibrating Parts
The non-vibrating parts is one of the parameters in videostroboscopy. The non-vibrating part is the part of the vocal cords that does not experience vibrations due to tissue rigidity. Assessment of this parameter is by dividing the right and left vocal cords into 10 regions each with an oval line. Changes in non-vibrating parts are recorded and statistically analysed.
Measured: Before injection, 1 week, 4 week, 8 week post-injection
Changes in Free Edge Contours
The free edge contours is one of the parameters in videostroboscopy. This parameter represents the free edge of the medial side of the vocal cords at maximal abduction. Changes in free edge contours are recorded and statistically analysed.
Measured: Before injection, 1 week, 4 week, 8 week post-injection
Changes in Symmetrical Pattern
This parameter assesses the symmetrical movement of the right and left vocal cords during oscillation using videostroboscopy. The results of the assessment on this parameter are symmetrical or asymmetrical. Changes in symmetrical pattern are recorded and statistically analysed.
Measured: Before injection, 1 week, 4 week, 8 week post-injection
Changes in Closure Phase
The closure phase is a parameter that compares the amount of closure and opening of the vocal cords in one glottic cycle. Assessment is done by looking at a collection of pictures from videostroboscopy when the vocal cords oscillate. Changes in closure phase are recorded and statistically analysed.
Measured: Before injection, 1 week, 4 week, 8 week post-injection
Changes in The Stability of The Vocal Cords
The stability of the vocal cords is a parameter that measures the vibration and amplitude of the vocal cords that are oscillating in one glottic cycle Assessment of this parameter where done through videostroboscopy. Changes in the stability of the vocal cords are recorded and statistically analysed.
Measured: Before injection, 1 week, 4 week, 8 week post-injection

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20181 Feb 2019

First posted9 Apr 2021
Study start1 Jan 2018
Primary completion1 Jun 2018
Study completion1 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (6)Papers the sponsor has linked to this study.
Other trials for Vocal Cord ParalysisStudies of the same condition, open and under way.
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 4
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: The intervention group will receive injection laryngoplasty with a combination of PRF and microlobular autograph fat, while the control group will receive injection laryngoplasty with microlobular autograph fat.
Masking: Single blind
Who is masked: Participant
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04839276
Sponsor's protocol ID: THT02
Status last verified: Apr 2021
First submitted: 29 Mar 2021
Last updated: 20 Apr 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Stachler RJ, Francis DO, Schwartz SR, Damask CC, Digoy GP, Krouse HJ, McCoy SJ, Ouellette DR, Patel RR, Reavis CCW, Smith LJ, Smith M, Strode SW, Woo P, Nnacheta LC. Clinical Practice Guideline: Hoarseness (Dysphonia) (Update) Executive Summary. Otolaryngol Head Neck Surg. 2018 Mar;158(3):409-426. doi: 10.1177/0194599817751031.
PubMed 29494316
Rubin AD, Sataloff RT. Vocal fold paresis and paralysis. Otolaryngol Clin North Am. 2007 Oct;40(5):1109-31, viii-ix. doi: 10.1016/j.otc.2007.05.012.
PubMed 17765698
Mattei A, Desuter G, Roux M, Lee BJ, Louges MA, Osipenko E, Sadoughi B, Schneider-Stickler B, Fanous A, Giovanni A. International consensus (ICON) on basic voice assessment for unilateral vocal fold paralysis. Eur Ann Otorhinolaryngol Head Neck Dis. 2018 Feb;135(1S):S11-S15. doi: 10.1016/j.anorl.2017.12.007. Epub 2018 Feb 3.
PubMed 29398504
Seyed Toutounchi SJ, Eydi M, Golzari SE, Ghaffari MR, Parvizian N. Vocal cord paralysis and its etiologies: a prospective study. J Cardiovasc Thorac Res. 2014;6(1):47-50. doi: 10.5681/jcvtr.2014.009. Epub 2014 Mar 4.
PubMed 24753832
Kwon TK, Buckmire R. Injection laryngoplasty for management of unilateral vocal fold paralysis. Curr Opin Otolaryngol Head Neck Surg. 2004 Dec;12(6):538-42. doi: 10.1097/01.moo.0000144393.40874.98.
PubMed 15548914
Graboyes EM, Bradley JP, Meyers BF, Nussenbaum B. Efficacy and safety of acute injection laryngoplasty for vocal cord paralysis following thoracic surgery. Laryngoscope. 2011 Nov;121(11):2406-10. doi: 10.1002/lary.22178. Epub 2011 Oct 12.
PubMed 21994176

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Vocal Cord Paralysis trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Administering Platelet-rich Fibrin to Autologous Fat Tissue in Injection Laryngoplasty for Unilateral Adductor Vocal Cord Paralysis
ClinicalTrials.gov ID: NCT04839276
Acronym / sponsor ID: THT02
Conditions: Vocal Cord Paralysis
Keywords: platelet-rich fibrin, vocal cord paralysis, dysphonia, injection laryngoplasty
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 19 participants (actual)
Lead sponsor: Fakultas Kedokteran Universitas IndonesiaUniversity, hospital or other
Study start: 1 Jan 2018 (actual)
Primary completion: 1 Jun 2018 (actual)
Study completion: 1 Feb 2019 (actual)
First posted: 9 Apr 2021 (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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2
Model description: The intervention group will receive injection laryngoplasty with a combination of PRF and microlobular autograph fat, while the control group will receive injection laryngoplasty with microlobular autograph fat.

Arm	Type	Receives
Injection Laryngoplasty with PRF and Autologous Fat	Experimental	Combination Product: Injection Laryngoplasty with Platelet-rich Fibrin and Autologous FatAutologous microlobular fat is harvested from abdominal fat (area under the umbilical). 4 mL of microlobular fat is added to 4 mL of PRF and is smoothed by pushing it back and forth 15 times on a 2-tube 10 mL piston tube connected to a three-way connector. 3 mL of the mixture of fat and PRF is injected using a 12 G laryngoplasty syringe until medialization is achieved.
Injection Laryngoplasty with Autologous Fat	Active comparator	Procedure: Injection Laryngoplasty with Autologous FatAutologous microlobular fat is harvested from abdominal fat (area under the umbilical). 4 mL of microlobular fat is mashed by pushing it back and forth 15 times in a container of 2 piston tubes (10 mL) connected to a three-way connector. The crushed fat is injected as much as 3 mL using a 12 G laryngoplasty syringe until medialization is achieved.

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Subject is diagnosed with unilateral vocal cord paralysis in paramedian position or 3 months lateral onset without movement and mucosal waves of the vocal cords on videostroboscopy.
Willing to give consent

Key exclusion criteria (3 listed)

Has a history of malignancy of the larynx or lung
Subject isn't able to undergo injection laryngoplasty procedure under general anesthesia
Subject with thrombositopenia

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
Injection Laryngoplasty with Platelet-rich Fibrin and Autologous FatAlso: RegenKit PRP Tube (Regen Lab)Injection Laryngoplasty with a combination of Platelet-rich Fibrin (PRF) and Autologous Fat. The PRF was made by taking 10 mL of peripheral blood from a healthy donor. Blood is then put inside the tube from the Regen lab kit. The tube was centrifuged with a force of 1,500 g (3000 rpm) for 5 minutes producing platelet-rich plasma (PRP). 4 mL of the aforementioned PRP was transferred to a 10 mL test tube, 1 M CaCl2 was added with a micropipette until final concentration of 25 mM was, reached producing PRF. Autologous fat harvested from the patient's abdomen was then mixed with the PRF solution to create the filler for injection laryngoplasty procedures. The injection procedures are done by placing the patient in a sniffing position followed by intraoral Kleinsasser laryngoscope insertion through the uvula, posterior pharyngeal wall, and epiglottis until the vocal cords are visible. Injection of the filler is then done to the paralyzed vocal cords.	Combination product	Injection Laryngoplasty with PRF and Autologous Fat
Injection Laryngoplasty with Autologous FatAlso: Lipid AutograftInjection Laryngoplasty with autologous microlobular fat harvested from the patient's abdominal fat. Lidocaine was infiltrated under the umbilicus and then an incision was made in the area followed by fat removal using scissors. The fat was cleaned with 0.9% NaCl solution and then sheared into microlobular form. The injection procedures are done by placing the patient in a sniffing position followed by intraoral Kleinsasser laryngoscope insertion through the uvula, posterior pharyngeal wall, and epiglottis until the vocal cords are visible. Injection of the filler is then done to the paralyzed vocal cords.	Procedure or surgery	Injection Laryngoplasty with Autologous Fat

Primary outcome

Change in Voice Handicap Index-30 (VHI-30) questionnaire score
Time frame: Before injection, 1 week, 4 week, 8 week post-injection
The Voice Handicap Index Questionnaire-30 (VHI-30) is a subjective examination that can be used to assess the severity of voice disorders and their impact on social life. The VHI-30 categorizes handicaps into mild, moderate, and severe. This study assessed the VHI-30 score as a numerical scale so that the median value for the treatment and control groups can be obtained. The assessment was carried out based on the patient's perception by addressing complaints for each question (0 = never, 1 = almost never, 2 = sometimes, 3 = almost always, 4 = always). Patients with severe voice disorders will achieve a higher VHI-30 score. Interpretation of the total value of the VHI-30 includes mild disability values of 0 - 30; moderate disability of 31 - 60; and a severe disability of 61-120. Changes in VHI-30 score are recorded and statistically analysed.
Changes in Maximum Phonation Time
Time frame: Before injection, 1 week, 4 week, 8 week post-injection
Maximum phonation time describes the quality of the strength of the vocal cords when oscillating. The calculation of the phonation time will represent objective assessment of voice. Changes in maximum phonation time are recorded and statistically analysed.
Changes in Average Fundamental Frequency (F0)
Time frame: Before injection, 1 week, 4 week, 8 week post-injection
The Average Fundamental Frequency (F0) is a parameter in MDVP that represents the number of vocal cord vibration cycles in one second. The mean frequency ranges from 120 Hz for men and 200 Hz for women, but this is also influenced by age, smoking and accent language. The average fundamental frequency reflects the biochemical characteristics of the vocal cords when interacting with the air flow in its path, these biochemical properties are influenced by the structure of the larynx and muscle tone. Changes in F0 are recorded and statistically analysed.
Changes in Jitter and Shimmer
Time frame: Before injection, 1 week, 4 week, 8 week post-injection
Jitter and Shimmer is a parameter in MDVP that represents variations that occur in the basic frequency. Jitter denotes the chaos of sound wave frequency caused by a lack of control over the vibration of the vocal cords. Shimmer shows the chaos of sound wave amplitude which is influenced by decreased resistance of the glottis and presence of mass lesions of the vocal cords, associated with inadequate adduction of the vocal cords and irregularity of the surface of the vocal cords. Presence of jitter and shimmer denotes that there are disruption in phonation quality caused by problems in vocal cords. Changes in jitter and shimmer are recorded and statistically analysed.
Changes in Noise to Harmonic Ratio (NHR)
Time frame: Before injection, 1 week, 4 week, 8 week post-injection
NHR is a parameter in MDVP that represents ratio of non-harmonic and harmonic waves in a certain sound wave period. NHR describes the quality of the amount of noise in the sound. Inadequate closure of the vocal cords and periodic vibrations of the vocal cords cause excessive air flow as it passes through the vocal cords, causing turbulence and noise. Normal and periodic sound signals will have a small NHR, while dysphonia sound signals will have a large NHR value. Changes in NHR are recorded and statistically analysed.
Changes in Voice Turbulence Index (VTI)
Time frame: Before injection, 1 week, 4 week, 8 week post-injection
VTI (Voice Turbulence Index) is a parameter in MDVP that represents the ratio between non-harmonic waves at high frequencies of 2800 - 5800 Hz and harmonic waves at frequencies of 70 - 4500 Hz. This parameter assesses the energy level of high frequency noise and is largely related to the turbulence of sound caused due to loss of adduction motion. This parameter also relates to variations in the frequency or amplitude of sound, where the turbulence of sound occurs due to changes in muscle control. Changes in VTI are recorded and statistically analysed.
Changes in Amplitude Tremor Intensity Index (ATRI)
Time frame: Before injection, 1 week, 4 week, 8 week post-injection
ATRI is a parameter in MDVP that represents the mean ratio of the low frequency amplitude to the total amplitude of the sound being examined. This parameter indicates the stability and strength of the vocal cords during phonation. Changes in ATRI are recorded and statistically analysed.
Changes in Vocal Cord Closure Pattern
Time frame: Before injection, 1 week, 4 week, 8 week post-injection
The closure pattern of the vocal cords is one of the parameters in videostroboscopy. This examination looks at the pattern and medial edge of the vocal cords when closed and insulated. Changes in Vocal Cord Closure Pattern are recorded and statistically analysed.
Changes in Amplitude
Time frame: Before injection, 1 week, 4 week, 8 week post-injection
The amplitude is one of the parameters in videostroboscopy. Amplitude is the amount of horizontal movement of the vocal cords. The magnitude of the amplitude is assessed by dividing the horizontal line into 5 sections from medial to lateral of the vocal cords. Changes in amplitude are recorded and statistically analysed.
Changes in Mucosal Waves
Time frame: Before injection, 1 week, 4 week, 8 week post-injection
The mucosal waves is one of the parameters in videostroboscopy. Mucosal waves are the movement of the vocal cords from an inferior to a superior direction following the glottic cycle on the vertical axis. Changes in mucosal waves are recorded and statistically analysed.
Changes in Vertical Level
Time frame: Before injection, 1 week, 4 week, 8 week post-injection
The vertical level is a parameter of the vocal cords on videostroboscopy that describes the difference in the height of the vocal cords that meet and are seen in the medial of the vocal cords. Changes in vertical level are recorded and statistically analysed.
Changes in Supraglottic Activity
Time frame: Before injection, 1 week, 4 week, 8 week post-injection
The supraglottic activity is one of the parameters in videostroboscopy. Supraglottic activity describes a narrowing of the supraglottic structure wherein one of them is a collapsed arytenoid. Changes in supraglottic activity are recorded and statistically analysed.
Changes in Non-vibrating Parts
Time frame: Before injection, 1 week, 4 week, 8 week post-injection
The non-vibrating parts is one of the parameters in videostroboscopy. The non-vibrating part is the part of the vocal cords that does not experience vibrations due to tissue rigidity. Assessment of this parameter is by dividing the right and left vocal cords into 10 regions each with an oval line. Changes in non-vibrating parts are recorded and statistically analysed.
Changes in Free Edge Contours
Time frame: Before injection, 1 week, 4 week, 8 week post-injection
The free edge contours is one of the parameters in videostroboscopy. This parameter represents the free edge of the medial side of the vocal cords at maximal abduction. Changes in free edge contours are recorded and statistically analysed.
Changes in Symmetrical Pattern
Time frame: Before injection, 1 week, 4 week, 8 week post-injection
This parameter assesses the symmetrical movement of the right and left vocal cords during oscillation using videostroboscopy. The results of the assessment on this parameter are symmetrical or asymmetrical. Changes in symmetrical pattern are recorded and statistically analysed.
Changes in Closure Phase
Time frame: Before injection, 1 week, 4 week, 8 week post-injection
The closure phase is a parameter that compares the amount of closure and opening of the vocal cords in one glottic cycle. Assessment is done by looking at a collection of pictures from videostroboscopy when the vocal cords oscillate. Changes in closure phase are recorded and statistically analysed.
Changes in The Stability of The Vocal Cords
Time frame: Before injection, 1 week, 4 week, 8 week post-injection
The stability of the vocal cords is a parameter that measures the vibration and amplitude of the vocal cords that are oscillating in one glottic cycle Assessment of this parameter where done through videostroboscopy. Changes in the stability of the vocal cords are recorded and statistically analysed.

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 20 Apr 2021.
Background: PubMed 29494316Stachler RJ, Francis DO, Schwartz SR, Damask CC, Digoy GP, Krouse HJ, McCoy SJ, Ouellette DR, Patel RR, Reavis CCW, Smith LJ, Smith M, Strode SW, Woo P, Nnacheta LC. Clinical Practice Guideline: Hoarseness (Dysphonia) (Update) Executive Summary. Otolaryngol Head Neck Surg. 2018 Mar;158(3):409-426. doi: 10.1177/0194599817751031.
Background: PubMed 17765698Rubin AD, Sataloff RT. Vocal fold paresis and paralysis. Otolaryngol Clin North Am. 2007 Oct;40(5):1109-31, viii-ix. doi: 10.1016/j.otc.2007.05.012.
Background: PubMed 29398504Mattei A, Desuter G, Roux M, Lee BJ, Louges MA, Osipenko E, Sadoughi B, Schneider-Stickler B, Fanous A, Giovanni A. International consensus (ICON) on basic voice assessment for unilateral vocal fold paralysis. Eur Ann Otorhinolaryngol Head Neck Dis. 2018 Feb;135(1S):S11-S15. doi: 10.1016/j.anorl.2017.12.007. Epub 2018 Feb 3.
Background: PubMed 24753832Seyed Toutounchi SJ, Eydi M, Golzari SE, Ghaffari MR, Parvizian N. Vocal cord paralysis and its etiologies: a prospective study. J Cardiovasc Thorac Res. 2014;6(1):47-50. doi: 10.5681/jcvtr.2014.009. Epub 2014 Mar 4.
Background: PubMed 15548914Kwon TK, Buckmire R. Injection laryngoplasty for management of unilateral vocal fold paralysis. Curr Opin Otolaryngol Head Neck Surg. 2004 Dec;12(6):538-42. doi: 10.1097/01.moo.0000144393.40874.98.
Background: PubMed 21994176Graboyes EM, Bradley JP, Meyers BF, Nussenbaum B. Efficacy and safety of acute injection laryngoplasty for vocal cord paralysis following thoracic surgery. Laryngoscope. 2011 Nov;121(11):2406-10. doi: 10.1002/lary.22178. Epub 2011 Oct 12.
Individual participant dataSharing planned: No

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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.

Mirta H Reksodiputro, SpTHT-KL(K) study chair

Department of ENT, Faculty of Medicine, University of Indonesia

Syahrial M Hutauruk, SpTHT-KL(K) study chair

Department of ENT, Faculty of Medicine, University of Indonesia

Trimartani Koento, SpTHT-KL(K) study chair

Department of ENT, Faculty of Medicine, University of Indonesia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 2 inclusion and 3 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 20 Apr 2021. 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 Indonesia. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Change in Voice Handicap Index-30 (VHI-30) questionnaire score (time frame: Before injection, 1 week, 4 week, 8 week post-injection). The study lists 17 primary outcomes in all. 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 NCT04839276, which also lists 6 linked publications.

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 20 Apr 2021.