Vocal Tremor
Conditions
Keywords
vocal tremor, botulinum toxin, laryngeal tremor
Brief summary
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
PROCEDUREFalse 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.
PROCEDUREElectromyography (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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Voice Handicap Index-10 (VHI-10) | Baseline, 4 weeks | To compare the change in Voice Handicap Index-10 (VHI-10) scores from baseline to 4 weeks between patients receiving FVF botulinum toxin injections and those receiving standard EMG-guided botulinum toxin injections. |
Countries
United States
Contacts
CONTACTWayAnne Watson, MD
CONTACTMollie Perryman, MD
PRINCIPAL_INVESTIGATORBlake Simpson, MD
University of Alabama at Birmingham
Outcome results
None listed