Propranolol and Botulinum Toxin for Essential Vocal Tremor

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Michael M Johns MD, Emory University
ClinicalTrials.gov Identifier:
NCT02111369
First received: April 8, 2014
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

Essential tremor is the most common adult-onset movement disorder, and essential voice tremor is the vocal manifestation of essential tremor. While nearly all essential tremor patients experience hand tremor, many also manifest head tremor and voice tremor. Essential voice tremor can lead to increased vocal effort, decreased intelligibility, and misconstrued emotional state. Only one medication, propranolol, is FDA-approved to treat essential tremor. Propranolol is not felt to be nearly as effective for axial tremors (head, trunk, neck) as it is for extremity tremors. However, this has not been studied with any objective assessment in a prospective way for EVT. For patients with essential voice tremor, the limited published data suggests that botulinum toxin has been shown to lead to functional voice improvement. Botulinum toxin, though also not well-studied with objective voice outcomes, is a commonly used clinical therapy for treatment of essential voice tremor. While it is used more often for essential voice tremor than propranolol therapy, botulinum toxin also has not been prospectively studied with validated, objective voice outcome measures. The investigators would like to determine if propranolol has any significant effect on vocal tremor. The investigators would also like to determine, in an objective way, the effect of botulinum toxin on vocal tremor. If effective, propranolol would provide an affordable and non-invasive alternative or addition to botulinum toxin injections for patients with essential voice tremor.


Condition Intervention Phase
Essential Vocal Tremor
Essential Voice Tremor
Essential Tremor
Voice Tremor
Vocal Tremor
Drug: Propranolol
Procedure: Botulinum Toxin
Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Propranolol and Botulinum Toxin for Essential Vocal Tremor

Resource links provided by NLM:


Further study details as provided by Emory University:

Primary Outcome Measures:
  • Change in Voice-Related Quality Of Life (VRQOL) questionnaire [ Time Frame: baseline, 2 weeks, 6 weeks ] [ Designated as safety issue: No ]

    Patient-Reported Measure

    • 10 questions for patient to score 1-5; 10-50 raw score


  • Change in Quality of Life in Essential Tremor (QUEST) questionnaire [ Time Frame: baseline, 2 weeks, 6 weeks ] [ Designated as safety issue: No ]

    Patient-Reported Measure

    • 30-item, Essential Tremor-specific quality of life scale


  • Change in Global voice rating [ Time Frame: baseline, 2 weeks, 6 weeks ] [ Designated as safety issue: No ]

    Patient-Reported Measure

    • 0-7 ranking


  • Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) tool [ Time Frame: baseline, 2 weeks, 6 weeks ] [ Designated as safety issue: No ]

    Objective Voice Assessment

    • Sustained vowel, sentences, running speech; 0-100 scale


  • Change in Acoustic Spectrograms [ Time Frame: baseline, 2 weeks, 6 weeks ] [ Designated as safety issue: No ]

    Objective Voice Assessment

    • Using the Computerized Speech Laboratory speech and voice analysis system (KayPENTAX, Montvale, NJ)



Estimated Enrollment: 30
Study Start Date: May 2014
Estimated Study Completion Date: May 2015
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Propranolol/Botulinum
After baseline analysis, patient will be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times per day (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the patient had demonstrated no side effects. Dose may be increased to 240 mg each day depending on patient improvement and side effect profile. After second evaluation, patient will receive botulinum toxin injections. The risks and benefits of botulinum toxin therapy will be explained to the patient, and bilateral injections will take place.
Drug: Propranolol
After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the patient had demonstrated no side effects. Dose may be increased to 240 mg each day depending on patient improvement and side effect profile.
Other Name: Inderal
Procedure: Botulinum Toxin
At the second evaluation, patient will receive botulinum toxin injections. The risks and benefits of botulinum toxin therapy will be explained to the patient, and bilateral injections will take place.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of essential voice tremor
  • Patients who have received or are planning to receive botulinum toxin injections for essential voice tremor
  • Patients who give informed consent to be contacted for research

Exclusion Criteria:

  • Patients who are already on a beta blocker
  • Patients who suffer from hypotension, bradycardia, or otherwise have a medical contraindication to beta blocker therapy (eg. moderate to severe bronchial asthma)

If the patient has received botulinum toxin injections for EVT previously, a three-month washout period is necessary before participation.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02111369

Locations
United States, Georgia
Emory Voice Center
Atlanta, Georgia, United States, 30308
Sponsors and Collaborators
Emory University
Investigators
Principal Investigator: Michael Johns, MD Emory Voice Center
  More Information

Publications:
Responsible Party: Michael M Johns MD, Director, Emory Voice Center, Emory University
ClinicalTrials.gov Identifier: NCT02111369     History of Changes
Other Study ID Numbers: IRB00072929
Study First Received: April 8, 2014
Last Updated: May 5, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Essential Tremor
Essential Vocal Tremor
Essential Voice Tremor

Additional relevant MeSH terms:
Essential Tremor
Tremor
Movement Disorders
Central Nervous System Diseases
Nervous System Diseases
Dyskinesias
Neurologic Manifestations
Signs and Symptoms
Botulinum Toxins
Propranolol
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Cardiovascular Agents
Antihypertensive Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on September 16, 2014