NCT02711995

Essential Voice Tremor: A Study of Botulinum Toxin Treatment and Injection Augmentation

Completed NA Results posted Last updated 5 February 2018

What this trial tests

NA trial testing RenuGel in Essential Tremor in 8 participants. Completed in 29 September 2016.

Timeline

15 December 2015

Primary endpoint
29 September 2016

29 September 2016

Quick facts

Lead sponsor	Weill Medical College of Cornell University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	8
Start date	15 December 2015
Primary completion	29 September 2016
Estimated completion	29 September 2016
Sites	1 location across United States

Drugs / interventions tested

• RenuGel — full drug profile →
• Botulinum Toxin — full drug profile →

Conditions studied

• Essential Tremor — all drugs for Essential Tremor →

Sponsor

Weill Medical College of Cornell University

Who can join

Adults 18 to 100, any sex, with Essential Tremor. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Vocal Tremor Scoring System (VTSS) Primary · Baseline and 30 days after intervention

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.

Base of tongue at Baseline

Group	Value	95% CI
Botulinum Toxin	0.57	± 0.79
RenuGel	0.57	± 0.53

Base of tongue 30 days after intervention

Group	Value	95% CI
Botulinum Toxin	1	± 1.29
RenuGel	0.43	± 1.13

Larynx at Baseline

Group	Value	95% CI
Botulinum Toxin	1.43	± 0.98
RenuGel	0.86	± 1.46

Larynx 30 days after intervention

Group	Value	95% CI
Botulinum Toxin	1.86	± 1.07
RenuGel	1.29	± 1.25

Palate at Baseline

Group	Value	95% CI
Botulinum Toxin	2.14	± 0.9
RenuGel	1.71	± 0.76

Palate 30 days after intervention

Group	Value	95% CI
Botulinum Toxin	1.71	± 0.95
RenuGel	1.86	± 0.9

Pharyngeal walls at baseline

Group	Value	95% CI
Botulinum Toxin	1.86	± 1.35
RenuGel	1.86	± 0.9

Pharyngeal walls 30 days after intervention

Group	Value	95% CI
Botulinum Toxin	1.86	± 0.9
RenuGel	1.14	± 1.07

Acoustic Analysis- Frequencies Secondary · Baseline and 30 days after intervention

For 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 w

CPP F0 Baseline

Group	Value	95% CI
Botulinum Toxin	203.13	± 35.70
RenuGel	195.06	± 36.15

CPP F0 30 Days after Intervention

Group	Value	95% CI
Botulinum Toxin	194.11	± 34.47
RenuGel	189.96	± 31.27

Fatr Baseline

Group	Value	95% CI
Botulinum Toxin	3.81	± 2.21
RenuGel	3.69	± 1.50

Fatr 30 days after intervention

Group	Value	95% CI
Botulinum Toxin	3.87	± 1.05
RenuGel	4.09	± 0.88

Fftr Baseline

Group	Value	95% CI
Botulinum Toxin	4.53	± 1.28
RenuGel	4.22	± 1.86

Fftr 30 days after intervention

Group	Value	95% CI
Botulinum Toxin	4.11	± 1.31
RenuGel	4.20	± 1.34

Aerodynamic Data- Airflow Secondary · Baseline and 30 days after intervention

Aerodynamic 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.

Mean airflow during voicing Baseline

Group	Value	95% CI
Botulinum Toxin	0.32	± 0.47
RenuGel	0.34	± 0.41

Mean airflow during voicing 30 days after interven

Group	Value	95% CI
Botulinum Toxin	0.38	± 0.60
RenuGel	0.26	± 0.25

Mean expiratory airflow Baseline

Group	Value	95% CI
Botulinum Toxin	0.31	± 0.38
RenuGel	0.35	± 0.40

Mean expiratory airflow 30 days after intervention

Group	Value	95% CI
Botulinum Toxin	0.42	± 0.63
RenuGel	0.23	± 0.21

Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Secondary · Baseline and 30 days after intervention

The 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 fro

Breathiness at Baseline

Group	Value	95% CI
Botulinum Toxin	40	± 31.49
RenuGel	47.14	± 28.56

Breathiness 30 days after intervention

Group	Value	95% CI
Botulinum Toxin	42.14	± 24.3
RenuGel	31.43	± 27.95

Loudness at Baseline

Group	Value	95% CI
Botulinum Toxin	23.57	± 33.26
RenuGel	30.71	± 31.81

Loudness 30 days after intervention

Group	Value	95% CI
Botulinum Toxin	29.29	± 31.01
RenuGel	20	± 24.32

Pitch at Baseline

Group	Value	95% CI
Botulinum Toxin	45.71	± 26.99
RenuGel	55.71	± 24.57

Pitch 30 days after intervention

Group	Value	95% CI
Botulinum Toxin	41.43	± 12.49
RenuGel	49.71	± 23.75

Roughness at Baseline

Group	Value	95% CI
Botulinum Toxin	32.14	± 19.76
RenuGel	37.14	± 21.38

Roughness 30 days after intervention

Group	Value	95% CI
Botulinum Toxin	32.43	± 21.52
RenuGel	30.71	± 15.39

Voice Handicap Index-10 (VHI-10) Secondary · Baseline and 30 days after intervention

The 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.

VHI-10 at Baseline

Group	Value	95% CI
Botulinum Toxin	26.29	± 10.69
RenuGel	25.86	± 10.61

VHI-10 at 30 days after Intervention

Group	Value	95% CI
Botulinum Toxin	23.57	± 7.41
RenuGel	29.86	± 8.49

Percent of Normal Function (PNF) Secondary · Baseline and 30 days after intervention

The 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.

PNF at Baseline

Group	Value	95% CI
Botulinum Toxin	0.40	± 0.32
RenuGel	0.34	± 0.34

PNF at 30 days after Intervention

Group	Value	95% CI
Botulinum Toxin	0.45	± 0.23
RenuGel	0.44	± 0.32

Aerodynamic Data- Peak Air Pressure Secondary · Baseline and 30 days after intervention

Aerodynamic 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.

Mean peak air pressure Baseline

Group	Value	95% CI
Botulinum Toxin	6.98	± 2.11
RenuGel	9.66	± 3.97

Mean peak air pressure 30 days after intervention

Group	Value	95% CI
Botulinum Toxin	7.91	± 4.13
RenuGel	10.08	± 4.04

Aerodynamic Data- Loudness Secondary · Baseline and 30 days after intervention

Aerodynamic 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.

Mean loudness Baseline

Group	Value	95% CI
Botulinum Toxin	82.67	± 8.26
RenuGel	85.16	± 5.02

Mean loudness 30 Days after Intervention

Group	Value	95% CI
Botulinum Toxin	81.40	± 6.29
RenuGel	84.82	± 5.04

Aerodynamic Data- Maximum Phonation Time Secondary · Baseline and 30 days after intervention

Aerodynamic 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.

Maximum Phonation Time Baseline

Group	Value	95% CI
Botulinum Toxin	12.27	± 10.34
RenuGel	10	± 10.57

Maximum Phonation Time 30 days after intervention

Group	Value	95% CI
Botulinum Toxin	9.21	± 5.08
RenuGel	9.34	± 7.52

Sponsor's own description

Botulinum toxin is the common treatment of choice for patients with Essential Voice Tremor (EVT), but results are not universally beneficial to all patients. Inconsistent results are noted in the literature and are consistent with the PI's clinical experience. Injection augmentation, a well-established treatment for glottic insufficiency, which is a prominent factor in the clinical presentation of Essential Voice Tremor (EVT), has not been studied. By treating patients at separate times with botulinum toxin and injection augmentation in an unblinded prospective crossover treatment study, we can assess functional outcomes of these two treatments with the population of patients with Essential Voice Tremor (EVT).

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.