False vocal fold Botox vs EMG-guided Botox for vocal tremor
Official title: False Vocal Fold vs EMG-Guided Botulinum Toxin Injections for Voice Tremor (FVFIVT): Prospective Non-Randomized Comparative Clinical Trial
Run by University of Alabama at Birmingham · NCT07577310 · Data updated 2026-11-12
This study tests whether injecting botulinum toxin into the false vocal fold is as good as the standard EMG-guided injection for people with essential vocal tremor.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 30 (estimated) |
| Sponsor | University of Alabama at Birmingham Academic / other |
| Locations | 2 sites (Birmingham, Alabama and 1 other locations) |
| Status | Recruiting |
| Started | January 22, 2026 |
| Main results expected | July 2028 |
| Study ends | July 2028 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT07577310 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with essential voice tremor who are suitable candidates for either false vocal fold or EMG-guided botulinum toxin injections and can complete English-language questionnaires.
✕Probably not a fit
Patients with coexisting conditions or baseline factors that limit response or follow-up may not experience benefit from either approach.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This prospective, non-randomized study compares two approaches to botulinum toxin injections for essential vocal tremor: injections into the false vocal fold versus injections guided by electromyography. Participants are assigned to one of the two methods through shared decision-making between the laryngologist and patient, and will be followed for 12 weeks to assess voice-related quality of life, tremor severity, and satisfaction. Outcomes from the two approaches will be described and compared to determine if the alternative technique offers similar or improved benefits. The trial will enroll adults with essential voice tremor who are deemed suitable candidates for either injection approach. Safety monitoring will include adverse events and tolerability of the procedures.
Why it matters
Potential benefit: If successful, patients may experience improved voice quality and tremor control with a potentially more tolerable or convenient injection approach.
How similar studies have gone: Prior studies in botulinum toxin injections for vocal tremor have shown benefit; the comparative use of false vocal fold injections is less established and this study explores a newer approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Diagnosis of essential voice tremor by a laryngologist and speech pathologist * Deemed an appropriate candidate for either FVF or EMG-guided botulinum toxin injections * Able to provide informed consent and complete questionnaires in English Exclusion Criteria: * Coexisting severe neurologic disease that precludes reliable participation in follow-up * History of laryngeal surgery or structural lesion that markedly confounds tremor assessment * Known hypersensitivity to botulinum toxin or injectable components * Pregnancy * Dysphagia at baseline * Inability to comply with follow-up schedule
Where it's running
-
UAB Hospital
Birmingham, Alabama, United States Recruiting -
University of Alabama at Birmingham
Birmingham, Alabama, United States Not yet recruiting
Study contacts
- Principal investigator: Blake Simpson, MD — University of Alabama at Birmingham
- Study coordinator: Bruno Vendramini, MD
- Email: bvendramini@uabmc.edu
- Phone: 205-801-7801
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.