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

NCT02711995 | Completed Results

• 1 other identifier: 1505016165
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Essential Tremor

Keywords

botulinum toxin; injection augmentation; essential voice tremor

Outcome Measures

Primary Outcomes (1)

• Vocal Tremor Scoring System (VTSS)

  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.

  Baseline and 30 days after intervention

Secondary Outcomes (8)

• Acoustic Analysis- Frequencies

  Baseline and 30 days after intervention

• Aerodynamic Data- Airflow

  Baseline and 30 days after intervention

• Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V)

  Baseline and 30 days after intervention

• Voice Handicap Index-10 (VHI-10)

  Baseline and 30 days after intervention

• Percent of Normal Function (PNF)

  Baseline and 30 days after intervention

Study Arms (2)

RenuGel

EXPERIMENTAL

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.

Drug: RenuGel

Botulinum toxin

ACTIVE COMPARATOR

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.

Drug: Botulinum Toxin

Interventions

RenuGel DRUG

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.

Also known as: generic: Carboxymethylcellulose

RenuGel

Botulinum Toxin DRUG

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.

Also known as: Botox

Botulinum toxin

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients ages 18-100 who have been diagnosed with essential tremor of the voice (EVT) Diagnosis Code 478.75 Laryngeal Spasm.

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Essential Tremor

Interventions

Botulinum Toxins; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Movement Disorders; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Results Point of Contact

• Title: Katerina Andreadis
• Organization: Weill Cornell Medicine

kaa2055@med.cornell.edu

646-962-9883

Study Officials

• Lucian Sulica, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: March 17, 2016
• Study Start: December 15, 2015
• Primary Completion: September 29, 2016
• Study Completion: September 29, 2016
• Last Updated: February 5, 2018
• Results First Posted: January 10, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)