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NCT Number: NCT07577310

False Vocal Fold vs EMG Guided Botox for Vocal Tremor

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.

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Key information

Conditions

Vocal Tremor

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location contact

Blake Simpson, MD

PRINCIPAL_INVESTIGATOR

Bruno Vendramini, MD

SUB_INVESTIGATOR

Edie Hapner, PhD, CC-SLP

SUB_INVESTIGATOR

Mollie Perryman, MD

CONTACT

[email protected]

205-801-7801

Molly Perryman, MD

SUB_INVESTIGATOR

WayAnne Watson, MD

CONTACT

[email protected]

205-801-7801

WayAnne Watson, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Voice Handicap Index-10 (VHI-10)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Mollie Perryman, MD

CONTACT

WayAnne Watson, MD

CONTACT

[email protected]

205-801-7801

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
May 11, 2026
Registry last updated
May 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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