Propranolol and Botulinum Toxin for Essential Vocal Tremor
Completed · Phase 4
Conditions studied: Essential Vocal Tremor, Essential Voice Tremor, Essential Tremor, Voice Tremor, Vocal Tremor
In brief
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.
Key facts
- Study ID
- NCT02111369
- Run by
- Emory University
- People needed
- 18
- Starts
- 2014-05-01
- Expected to finish
- 2014-11-01
- Last updated by the study team
- 2016-04-27
Who can join
Age: 45 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Emory Voice Center — Atlanta, Georgia, United States
Full record on ClinicalTrials.gov
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