Clinical evaluation and treatment of voice tremor with botulinum toxin and propranolol.

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-389mzn
• Date of registration: 31/01/2012
• Primary sponsor: Universidade Federal de São Paulo - Brazil
• Public title: Clinical evaluation and treatment of voice tremor with botulinum toxin and propranolol.
• Scientific title: Clinical evaluation and treatment of voice tremor with botulinum toxin and propranolol.
• Date of first enrolment: 01/04/2011
• Target sample size: 20
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-389mzn/
• Study design: Clinical trial, prospective, single blinded trial, parallel, non-randomized controlled phase 4.

Countries of recruitment

Brazil

Contacts

• Name: Bruno Moraes
• Affiliation: Universidade Federal de São Paulo

• Name: Bruno Moraes
• Affiliation: Universidade Federal de São Paulo

Key inclusion & exclusion criteria

Inclusion criteria: presence of vocal tremor to perceptual analysis and larynx; older than 18 years, both sexes
Exclusion criteria: presence of laryngeal spasm during laryngoscopy or auditory perceptual, presence of lesions on laryngoscopy, patients with previous treatment, contraindication to propranolol or botulinum toxin

Age minimum: 18Y
Age maximum: 0
Gender: -

Health Condition(s) or Problem(s) studied

Patients with vocal tremor
C10.597.350.850

Intervention(s)

Intervention Group 1: Patients with vocal tremor subjected to the use of Propranolol tablets orally in increasing doses and increments of 20-80 mg per day administered twice daily with a duration of 1 month. The increase in dose is 20 mg weekly.

Intervention Group 2: Botulinum toxin into the vocal fold: treatment with botulinum toxin type A in thyroarytenoid muscle in a single dose of 2-4 units, whose effect lasts about 3-6 months. The injection is performed with a needle on neck and guided percutaneous laryngeal electromyography.

The evaluation of treatment response of both groups will be conducted from the comparison among them the parameters of the perceptual analysis and acoustic collected before and after (30 days) intervention by otolaryngologist and speech pathologist blinded to the study.

You will list possible side effects of treatment with interruption of therapy if necessary.

Primary Outcome(s)

Perceptual-hearing evaluation of voice will be conducted through the scale RASAT whose main parameter is the measurement of vocal instability in a score of 0-3.


The parameters of acoustic analysis will be evaluated:

Fundamental frequency;
Standard deviation of Fundamental Frequency;
Variability of Fundamental Frequency;
Jitter and shimmer;
Diagram phonatory deviation;

Secondary Outcome(s)

Assessment will be conducted through patient satisfaction visual analog scale 0-100 mm, with the parameters:

Overall satisfaction
Improved voice
Decreased tremor
Swallowing problems. Which week?
Breathiness. Which week?
Cough. Which week?

Secondary ID(s)

1853/10

Source(s) of Monetary Support

Capes - Brazil

Secondary Sponsor(s)

Capes - Brazil