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Propranolol and Botulinum Toxin for Essential Vocal Tremor

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02111369
First Posted: April 11, 2014
Last Update Posted: April 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Michael M Johns MD, Emory University
  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: None (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 Michael M Johns MD, Emory University:

Primary Outcome Measures:
  • Change in Quality of Life in Essential Tremor (QUEST) Questionnaire Score [ Time Frame: Baseline, 2 weeks, 6 weeks ]
    The QUEST questionnaire is a 30 item self-reported essential tremor-specific quality of life scale that asks participants to rate responses (never/no, rarely, sometimes, frequently, always/yes, or not applicable). Total scores range between 0 to 100 where 0 is the best score and 100 is the worst score. A higher score indicates a lower quality of life.

  • Change in Voice-Related Quality Of Life (VRQOL) Questionnaire Score [ Time Frame: Baseline, 2 weeks, 6 weeks ]
    The VRQOL is a ten question self-reported measure that asks patients to rate responses from 1-5 (1=none, not a problem, 2=a small amount, 3=a moderate (medium) amount, 4=a lot, 5=problem is as "bad as it can be"). Total scores range from 0 to 100. A higher score indicates more problems interfering with day to day activities.

  • Change in Consensus Auditory-Perceptual Evaluation of Voice (CAPE-V) Score [ Time Frame: Baseline, 2 weeks, 6 weeks ]
    The CAPE-V is a clinically validated perceptual voice assessment tool that is used to describe the severity of auditory-perceptual attributes of a voice problem, in a way that can be communicated among clinicians. Participant's speech is recorded and evaluated by trained "listeners". Listeners indicate overall tremor severity by making a tick mark on a 1 to 100 mm visual analog scale. Total scores range from 0 to 100 where 0 is the best score and 100 is the worst score.

  • Change in Global Voice Rating [ Time Frame: Baseline, 2 weeks, 6 weeks ]

    Patient-Reported Measure

    • 0-7 ranking


  • Change in Acoustic Spectrograms [ Time Frame: baseline, 2 weeks, 6 weeks ]

    Objective Voice Assessment

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



Enrollment: 18
Study Start Date: May 2014
Study Completion Date: November 2014
Primary Completion Date: October 2014 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: April 8, 2014
First Posted: April 11, 2014
Results First Submitted: February 24, 2016
Results First Posted: April 27, 2016
Last Update Posted: April 27, 2016
Last Verified: March 2016

Keywords provided by Michael M Johns MD, Emory University:
Essential Tremor
Essential Vocal Tremor
Essential Voice Tremor

Additional relevant MeSH terms:
Tremor
Essential Tremor
Dyskinesias
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Movement Disorders
Central Nervous System Diseases
Botulinum Toxins
Propranolol
Acetylcholine Release Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Vasodilator Agents