Recruiting

FVF vs. EMG-guided

Sponsor:

University of Alabama at Birmingham

Code:

NCT07577310

Conditions

Vocal Tremor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

False Vocal Fold (FVF) botulinum toxin injections

Electromyography (EMG)-Guided Injection

Study Details

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.

Conditions

Vocal Tremor

Study ID

NCT07577310

Start date

Jan 22, 2026

Status verified date

Nov, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

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 measure

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

Central Contacts and Locations

Central contacts

Bruno Vendramini, MD

205-801-7801bvendramini@uabmc.edu

Locations

UAB Hospital

Recruiting

Birmingham, Alabama, United States, 35213-3614

Contacts

Charles Simpson

2108678540simpsonvoice@gmail.com

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Nov 5, 2026

Last verified

Nov, 2026

Keywords

  • vocal tremor
  • botulinum toxin
  • laryngeal tremor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-06. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-11-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.