False Vocal Fold vs EMG Guided Botox for Vocal Tremor
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: False Vocal Fold (FVF) botulinum toxin injections, Electromyography (EMG)-Guided Injection.
- Who it may be relevant to
- Registry conditions: Vocal Tremor. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
False Vocal Fold vs EMG-Guided Botulinum Toxin Injections for Voice Tremor (FVFIVT): Prospective Non-Randomized Comparative Clinical Trial
Overview
This is a prospective, non-randomized, two-arm comparative clinical trial evaluating outcomes of false vocal fold (FVF) botulinum toxin injections versus standard EMG-guided botulinum toxin injections in patients with essential voice tremor. Participants will receive either FVF injections or EMG-guided injections based on shared clinical decision-making between the treating laryngologist and patient. The study will assess changes in voice-related quality of life, tremor severity, and patient satisfaction over a 12-week follow-up period and compare these outcomes between the two treatment approaches.
Interventions
- Procedure False Vocal Fold (FVF) botulinum toxin injections
False vocal fold (FVF) injection, or supraglottic injection, is a specialized treatment primarily using Botox to treat severe Adductor Spasmodic Dysphonia (ADSD). It involves injecting botulinum toxin into the false cords to reduce involuntary squeezing (hyperadduction), offering a potential alternative or supplement to traditional true vocal fold injections to minimize breathiness while improving voice quality. - Procedure Electromyography (EMG)-Guided Injection
EMG-guided injection is a precise medical technique using electromyography (EMG) to locate specific muscles for botulinum toxin (Botox/Dysport) injections. It uses auditory and visual signals to confirm needle placement in active muscles, enhancing accuracy for treating spasticity, dystonia, and laryngological conditions.
Primary outcome measures
- Change in Voice Handicap Index-10 (VHI-10) [Time frame: Baseline, 4 weeks]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Alabama at Birmingham — Birmingham
Publications
- Simpson CB, Lee CT, Hatcher JL, Michalek J. Botulinum toxin treatment of false vocal folds in adductor spasmodic dysphonia: Functional outcomes. Laryngoscope. 2016 Jan;126(1):118-21. doi: 10.1002/lary.25515. Epub 2015 Oct 15. PMID 26467807
Identifiers
NCT: NCT07577310 · IRB-300015963 · UAB