False Vocal Fold vs EMG-Guided Botulinum Toxin Injections for Voice Tremor (FVFIVT): Prospective Non-Randomized Comparative Clinical Trial

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.

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

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.

Location