False Vocal Fold vs EMG Guided Botox for Vocal Tremor

Conditions

• Vocal Tremor

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• False Vocal Fold (FVF) botulinum toxin injections — PROCEDURE
  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.
• Electromyography (EMG)-Guided Injection — PROCEDURE
  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.

Study Details

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.

Key Dates

Start date

Aug 31, 2026

Status verified

Apr 2026

Primary completion

Jul 31, 2030

Completion

Jul 31, 2030

Study Design

Enrollment

30 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Active Comparator: Participants Receiving False Vocal Fold (FVF) Injection
  Participants receive endoscopic-guided Onabotulinum toxin A injections to false vocal folds. Dosing and laterality (unilateral vs bilateral) will follow routine clinical practice guided by shared decision making with patient, laryngologist and speech pathologist.
• Active Comparator: Participants Receiving Electromyography (EMG)-Guided Injection
  Participants receive Electromyography (EMG)-guided botulinum toxin A injections into the TA/LCA muscles or equivalent targets per standard of care.

Primary Outcome Measure

Change in Voice Handicap Index-10 (VHI-10) [ Time Frame: Baseline, 4 weeks ]

Central Contacts

• WayAnne Watson, MD
  205-801-7801
  [email protected]
• Mollie Perryman, MD

Locations (1)

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