Trial Outcomes & Findings for Essential Voice Tremor: A Study of Botulinum Toxin Treatment and Injection Augmentation (NCT NCT02711995)
NCT ID: NCT02711995
Last Updated: 2018-02-05
Results Overview
The Vocal Tremor Scoring System (VTSS) was developed to standardize the evaluation and scaling of vocal tremor. Tremor at a specific site was scored according to severity by the laryngologist. It can be rated as: none (0), mild/intermittent (1), moderate (2), severe (3). Six different regions were evaluated in this study: base of tongue, larynx, palate, pharyngeal walls, supraglottis, and true vocal folds. The scale range for each region was 0-3. The total score was a summation of all six regions, with a scalar range of 0-18.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
Baseline and 30 days after intervention
Results posted on
2018-02-05
Participant Flow
Eight patients were enrolled in the study, and seven patients completed the study. The first participant enrolled on December 15, 2015 and the last patient completed the study on September 29, 2016. All patients were seen at Weill Cornell Medicine ENT located at 1305 York Avenue,5th Floor NY NY 10021
One patient was excluded prior to the second intervention. Her neurologist started her on a medication that could have confounded our findings, therefore her participation in the study ended. She still received treatment, but was no longer considered a study subject.
Participant milestones
| Measure |
Botulinum Toxin First and RenuGel After
Patients with essential voice tremor underwent botulinum toxin chemodenervation injection. After washout (90 days) , patients underwent injection augmentation. Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril.
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|---|---|
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Washout (90 Days)
STARTED
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8
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Washout (90 Days)
COMPLETED
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7
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Washout (90 Days)
NOT COMPLETED
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1
|
|
Second Intervention (30 Days)
STARTED
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7
|
|
Second Intervention (30 Days)
COMPLETED
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7
|
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First Intervention (30 Days)
STARTED
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8
|
|
First Intervention (30 Days)
COMPLETED
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8
|
|
First Intervention (30 Days)
NOT COMPLETED
|
0
|
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Second Intervention (30 Days)
NOT COMPLETED
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0
|
Reasons for withdrawal
| Measure |
Botulinum Toxin First and RenuGel After
Patients with essential voice tremor underwent botulinum toxin chemodenervation injection. After washout (90 days) , patients underwent injection augmentation. Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril.
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|---|---|
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Washout (90 Days)
Conflicting medication
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1
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Baseline Characteristics
Essential Voice Tremor: A Study of Botulinum Toxin Treatment and Injection Augmentation
Baseline characteristics by cohort
| Measure |
Botulinum Toxin First and RenuGel After
n=7 Participants
Patients with essential voice tremor underwent botulinum toxin chemodenervation injection. After washout (90 days) , patients underwent injection augmentation. Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=5 Participants
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Age, Categorical
Between 18 and 65 years
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3 Participants
n=5 Participants
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Age, Categorical
>=65 years
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4 Participants
n=5 Participants
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Age, Continuous
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62 years
n=5 Participants
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Sex: Female, Male
Female
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5 Participants
n=5 Participants
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Sex: Female, Male
Male
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2 Participants
n=5 Participants
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Region of Enrollment
United States
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7 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline and 30 days after interventionThe Vocal Tremor Scoring System (VTSS) was developed to standardize the evaluation and scaling of vocal tremor. Tremor at a specific site was scored according to severity by the laryngologist. It can be rated as: none (0), mild/intermittent (1), moderate (2), severe (3). Six different regions were evaluated in this study: base of tongue, larynx, palate, pharyngeal walls, supraglottis, and true vocal folds. The scale range for each region was 0-3. The total score was a summation of all six regions, with a scalar range of 0-18.
Outcome measures
| Measure |
RenuGel
n=7 Participants
Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.
RenuGel: Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.
|
Botulinum Toxin
n=7 Participants
Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.
Botulinum Toxin: Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.
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|---|---|---|
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Vocal Tremor Scoring System (VTSS)
Base of tongue at Baseline
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0.57 units on a scale
Standard Deviation 0.53
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0.57 units on a scale
Standard Deviation 0.79
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Vocal Tremor Scoring System (VTSS)
Base of tongue 30 days after intervention
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0.43 units on a scale
Standard Deviation 1.13
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1 units on a scale
Standard Deviation 1.29
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Vocal Tremor Scoring System (VTSS)
Larynx at Baseline
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0.86 units on a scale
Standard Deviation 1.46
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1.43 units on a scale
Standard Deviation 0.98
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Vocal Tremor Scoring System (VTSS)
Larynx 30 days after intervention
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1.29 units on a scale
Standard Deviation 1.25
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1.86 units on a scale
Standard Deviation 1.07
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Vocal Tremor Scoring System (VTSS)
Palate at Baseline
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1.71 units on a scale
Standard Deviation 0.76
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2.14 units on a scale
Standard Deviation 0.9
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Vocal Tremor Scoring System (VTSS)
Palate 30 days after intervention
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1.86 units on a scale
Standard Deviation 0.9
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1.71 units on a scale
Standard Deviation 0.95
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Vocal Tremor Scoring System (VTSS)
Pharyngeal walls at baseline
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1.86 units on a scale
Standard Deviation 0.9
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1.86 units on a scale
Standard Deviation 1.35
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Vocal Tremor Scoring System (VTSS)
Pharyngeal walls 30 days after intervention
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1.14 units on a scale
Standard Deviation 1.07
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1.86 units on a scale
Standard Deviation 0.9
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Vocal Tremor Scoring System (VTSS)
Supraglottis at Baseline
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1.57 units on a scale
Standard Deviation 0.98
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2.14 units on a scale
Standard Deviation 0.69
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Vocal Tremor Scoring System (VTSS)
Supraglottis 30 days after intervention
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1.71 units on a scale
Standard Deviation 0.76
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1 units on a scale
Standard Deviation 0.82
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Vocal Tremor Scoring System (VTSS)
True Vocal Folds at Baseline
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1.71 units on a scale
Standard Deviation 0.95
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2.14 units on a scale
Standard Deviation 0.9
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Vocal Tremor Scoring System (VTSS)
True Vocal Folds 30 days after intervention
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1.43 units on a scale
Standard Deviation 1.27
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1.57 units on a scale
Standard Deviation 0.98
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Vocal Tremor Scoring System (VTSS)
Total at Baseline
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8.29 units on a scale
Standard Deviation 3.25
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10.29 units on a scale
Standard Deviation 3.15
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Vocal Tremor Scoring System (VTSS)
Total at 30 days after intervention
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7.86 units on a scale
Standard Deviation 3.98
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9 units on a scale
Standard Deviation 2.83
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SECONDARY outcome
Timeframe: Baseline and 30 days after interventionFor acoustic assessment, subjects produced a sustained /a/ sound at their habitual speaking pitch and loudness and read assessment sentences from the Consensus Audio-Perceptual Evaluation of Voice (CAPE-V)protocol. Tasks were recorded and analyzed using the Analysis of Dysphonia in Speech and Voice (ADSV) and Multi-Dimensional Voice Profile (MDVP) software. A handheld microphone 3 inches from the subjects' mouths was used for all recordings. The Sustained Vowel and All-Voiced Sentence protocols of the ADSV were used to obtain cepstral peak prominence fundamental frequency (CPP F0), The MDVP was used to obtain amplitude tremor frequency (Fatr), and fundamental frequency tremor frequency (Fftr).
Outcome measures
| Measure |
RenuGel
n=7 Participants
Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.
RenuGel: Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.
|
Botulinum Toxin
n=7 Participants
Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.
Botulinum Toxin: Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.
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Acoustic Analysis- Frequencies
CPP F0 Baseline
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195.06 Frequency (Hz)
Standard Deviation 36.15
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203.13 Frequency (Hz)
Standard Deviation 35.70
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Acoustic Analysis- Frequencies
CPP F0 30 Days after Intervention
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189.96 Frequency (Hz)
Standard Deviation 31.27
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194.11 Frequency (Hz)
Standard Deviation 34.47
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Acoustic Analysis- Frequencies
Fatr Baseline
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3.69 Frequency (Hz)
Standard Deviation 1.50
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3.81 Frequency (Hz)
Standard Deviation 2.21
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Acoustic Analysis- Frequencies
Fatr 30 days after intervention
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4.09 Frequency (Hz)
Standard Deviation 0.88
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3.87 Frequency (Hz)
Standard Deviation 1.05
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Acoustic Analysis- Frequencies
Fftr Baseline
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4.22 Frequency (Hz)
Standard Deviation 1.86
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4.53 Frequency (Hz)
Standard Deviation 1.28
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Acoustic Analysis- Frequencies
Fftr 30 days after intervention
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4.20 Frequency (Hz)
Standard Deviation 1.34
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4.11 Frequency (Hz)
Standard Deviation 1.31
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SECONDARY outcome
Timeframe: Baseline and 30 days after interventionAerodynamic data were collected using the Phonatory Aerodynamic System (PAS) 6600 (Pentax). Subjects held a facemask coupled to a pneumotachometer with a pressure-sensor tube firmly over the nose and mouth, and rested the pressure-sensor tube in the oral cavity above the tongue. They produced sustained /a/ and "We were away a year ago," from which mean airflow wasanalyzed via the Maximum Sustained Phonation and Running Speech protocols.
Outcome measures
| Measure |
RenuGel
n=7 Participants
Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.
RenuGel: Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.
|
Botulinum Toxin
n=7 Participants
Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.
Botulinum Toxin: Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.
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|---|---|---|
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Aerodynamic Data- Airflow
Mean airflow during voicing Baseline
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0.34 Liters per second (L/s)
Standard Deviation 0.41
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0.32 Liters per second (L/s)
Standard Deviation 0.47
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Aerodynamic Data- Airflow
Mean airflow during voicing 30 days after interven
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0.26 Liters per second (L/s)
Standard Deviation 0.25
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0.38 Liters per second (L/s)
Standard Deviation 0.60
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Aerodynamic Data- Airflow
Mean expiratory airflow Baseline
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0.35 Liters per second (L/s)
Standard Deviation 0.40
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0.31 Liters per second (L/s)
Standard Deviation 0.38
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Aerodynamic Data- Airflow
Mean expiratory airflow 30 days after intervention
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0.23 Liters per second (L/s)
Standard Deviation 0.21
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0.42 Liters per second (L/s)
Standard Deviation 0.63
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SECONDARY outcome
Timeframe: Baseline and 30 days after interventionThe Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) is used to describe the severity of auditory-perceptual attributes of a voice problem. It indicates salient perceptual vocal attributes: (a) Overall Severity; (b) Roughness; (c) Breathiness; (d) Strain; (e) Pitch; and (f) Loudness. The CAPE-V displays each attribute accompanied by a 100- millimeter line forming a visual analog scale (VAS). The clinician indicates the degree of perceived deviance from normal for each parameter on this scale, using a tic mark. For each dimension, scalar extremes are unlabeled. The scale range is from 0mm to 100mm. Results can indicate distance in mm to describe the degree of deviancy, so the higher the score the more deviancy from the norm there is.
Outcome measures
| Measure |
RenuGel
n=7 Participants
Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.
RenuGel: Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.
|
Botulinum Toxin
n=7 Participants
Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.
Botulinum Toxin: Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.
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|---|---|---|
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Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Breathiness at Baseline
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47.14 units on a scale
Standard Deviation 28.56
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40 units on a scale
Standard Deviation 31.49
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Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Breathiness 30 days after intervention
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31.43 units on a scale
Standard Deviation 27.95
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42.14 units on a scale
Standard Deviation 24.3
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Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Loudness at Baseline
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30.71 units on a scale
Standard Deviation 31.81
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23.57 units on a scale
Standard Deviation 33.26
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Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Loudness 30 days after intervention
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20 units on a scale
Standard Deviation 24.32
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29.29 units on a scale
Standard Deviation 31.01
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Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Pitch at Baseline
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55.71 units on a scale
Standard Deviation 24.57
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45.71 units on a scale
Standard Deviation 26.99
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Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Pitch 30 days after intervention
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49.71 units on a scale
Standard Deviation 23.75
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41.43 units on a scale
Standard Deviation 12.49
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Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Roughness at Baseline
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37.14 units on a scale
Standard Deviation 21.38
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32.14 units on a scale
Standard Deviation 19.76
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Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Roughness 30 days after intervention
|
30.71 units on a scale
Standard Deviation 15.39
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32.43 units on a scale
Standard Deviation 21.52
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Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Strain at Baseline
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55 units on a scale
Standard Deviation 30.41
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59.29 units on a scale
Standard Deviation 24.4
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Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Strain 30 days after intervention
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52.86 units on a scale
Standard Deviation 23.07
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41.43 units on a scale
Standard Deviation 23.22
|
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Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Overall at Baseline
|
64 units on a scale
Standard Deviation 27.59
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63.71 units on a scale
Standard Deviation 24.47
|
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Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)
Overall after intervention
|
56.43 units on a scale
Standard Deviation 21.93
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55.43 units on a scale
Standard Deviation 24.21
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SECONDARY outcome
Timeframe: Baseline and 30 days after interventionThe Voice Handicap Index-10 consists of 10 questions (statements about voice), where patients rate their the frequency of their problems as: never (0), almost never (1), sometimes (2), almost always (3), and always (4). The scores from each answer are added, and can range from 0-40. The higher the score, the worse the patient's perception of their voice handicap.
Outcome measures
| Measure |
RenuGel
n=7 Participants
Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.
RenuGel: Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.
|
Botulinum Toxin
n=7 Participants
Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.
Botulinum Toxin: Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.
|
|---|---|---|
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Voice Handicap Index-10 (VHI-10)
VHI-10 at Baseline
|
25.86 units on a scale
Standard Deviation 10.61
|
26.29 units on a scale
Standard Deviation 10.69
|
|
Voice Handicap Index-10 (VHI-10)
VHI-10 at 30 days after Intervention
|
29.86 units on a scale
Standard Deviation 8.49
|
23.57 units on a scale
Standard Deviation 7.41
|
SECONDARY outcome
Timeframe: Baseline and 30 days after interventionThe Percent of Normal Function (PNF) is a scale for patients to rate their recurrent functions in increments of five, from no function (0%) to normal function (100%). The higher the percentage, the more normal the function as experienced by the patient.
Outcome measures
| Measure |
RenuGel
n=7 Participants
Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.
RenuGel: Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.
|
Botulinum Toxin
n=7 Participants
Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.
Botulinum Toxin: Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.
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|---|---|---|
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Percent of Normal Function (PNF)
PNF at Baseline
|
0.34 percentage of normal function
Standard Deviation 0.34
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0.40 percentage of normal function
Standard Deviation 0.32
|
|
Percent of Normal Function (PNF)
PNF at 30 days after Intervention
|
0.44 percentage of normal function
Standard Deviation 0.32
|
0.45 percentage of normal function
Standard Deviation 0.23
|
SECONDARY outcome
Timeframe: Baseline and 30 days after interventionAerodynamic data were collected using the Phonatory Aerodynamic System (PAS) 6600 (Pentax). Subjects held a facemask coupled to a pneumotachometer with a pressure-sensor tube firmly over the nose and mouth, and rested the pressure-sensor tube in the oral cavity above the tongue. A string of five consonant-vowel syllables (/pa/) at a comfortable pitch and loudness were analyzed through the Voicing Efficiency protocol to determine mean peak air pressure.
Outcome measures
| Measure |
RenuGel
n=7 Participants
Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.
RenuGel: Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.
|
Botulinum Toxin
n=7 Participants
Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.
Botulinum Toxin: Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.
|
|---|---|---|
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Aerodynamic Data- Peak Air Pressure
Mean peak air pressure Baseline
|
9.66 Centimeter of water (cm H2O)
Standard Deviation 3.97
|
6.98 Centimeter of water (cm H2O)
Standard Deviation 2.11
|
|
Aerodynamic Data- Peak Air Pressure
Mean peak air pressure 30 days after intervention
|
10.08 Centimeter of water (cm H2O)
Standard Deviation 4.04
|
7.91 Centimeter of water (cm H2O)
Standard Deviation 4.13
|
SECONDARY outcome
Timeframe: Baseline and 30 days after interventionAerodynamic data were collected using the Phonatory Aerodynamic System (PAS) 6600 (Pentax). Subjects held a facemask coupled to a pneumotachometer with a pressure-sensor tube firmly over the nose and mouth, and rested the pressure-sensor tube in the oral cavity above the tongue. They produced sustained /a/ and "We were away a year ago," from which loudness was analyzed via the Maximum Sustained Phonation and Running Speech protocols.
Outcome measures
| Measure |
RenuGel
n=7 Participants
Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.
RenuGel: Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.
|
Botulinum Toxin
n=7 Participants
Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.
Botulinum Toxin: Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.
|
|---|---|---|
|
Aerodynamic Data- Loudness
Mean loudness Baseline
|
85.16 Decibel of sound pressure level (dB SPL)
Standard Deviation 5.02
|
82.67 Decibel of sound pressure level (dB SPL)
Standard Deviation 8.26
|
|
Aerodynamic Data- Loudness
Mean loudness 30 Days after Intervention
|
84.82 Decibel of sound pressure level (dB SPL)
Standard Deviation 5.04
|
81.40 Decibel of sound pressure level (dB SPL)
Standard Deviation 6.29
|
SECONDARY outcome
Timeframe: Baseline and 30 days after interventionAerodynamic data were collected using the Phonatory Aerodynamic System (PAS) 6600 (Pentax). Subjects held a facemask coupled to a pneumotachometer with a pressure-sensor tube firmly over the nose and mouth, and rested the pressure-sensor tube in the oral cavity above the tongue. They produced sustained /a/ from which Maximum Sustained Phonation time was recorded.
Outcome measures
| Measure |
RenuGel
n=7 Participants
Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.
RenuGel: Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.
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Botulinum Toxin
n=7 Participants
Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.
Botulinum Toxin: Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.
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Aerodynamic Data- Maximum Phonation Time
Maximum Phonation Time Baseline
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10 seconds (s)
Standard Deviation 10.57
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12.27 seconds (s)
Standard Deviation 10.34
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Aerodynamic Data- Maximum Phonation Time
Maximum Phonation Time 30 days after intervention
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9.34 seconds (s)
Standard Deviation 7.52
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9.21 seconds (s)
Standard Deviation 5.08
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Adverse Events
Botulinum Toxin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
RenuGel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place