N/A
Completed N=8
Essential Voice Tremor: A Study of Botulinum Toxin Treatment and Injection Augmentation
Source: ClinicalTrials.gov NCT02711995 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcomePrimary: Vocal Tremor Scoring System (VTSS) — 0.57; 0.57; 1; 0.43 units on a scale
Summary
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vocal Tremor Scoring System (VTSS) |
0.57; 0.57; 1; 0.43; 1.43; 0.86 | — |
| SECONDARY Acoustic Analysis- Frequencies |
203.13; 195.06; 194.11; 189.96; 3.81; 3.69 | — |
| SECONDARY Aerodynamic Data- Airflow |
0.32; 0.34; 0.38; 0.26; 0.31; 0.35 | — |
| SECONDARY Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) |
40; 47.14; 42.14; 31.43; 23.57; 30.71 | — |
| SECONDARY Voice Handicap Index-10 (VHI-10) |
26.29; 25.86; 23.57; 29.86 | — |
| SECONDARY Percent of Normal Function (PNF) |
0.40; 0.34; 0.45; 0.44 | — |
| SECONDARY Aerodynamic Data- Peak Air Pressure |
6.98; 9.66; 7.91; 10.08 | — |
| SECONDARY Aerodynamic Data- Loudness |
82.67; 85.16; 81.40; 84.82 | — |
| SECONDARY Aerodynamic Data- Maximum Phonation Time |
12.27; 10; 9.21; 9.34 | — |
Eligibility Criteria
Inclusion Criteria
- Male and female patients ages 18-100 who have been diagnosed with essential tremor of the voice (EVT) Diagnosis Code 478.75 Laryngeal Spasm.
Exclusion Criteria
- WCMC subjects under age 18
- Pregnant patients
- Patients with laryngeal pathology besides tremor, including but not limited to polyps and other benign lesions, precancerous or cancerous changes, vocal fold paralysis, or other laryngeal disorders of mobility
Data sourced from ClinicalTrials.gov (NCT02711995). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.