NCT07577310

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
48mo left

Started Aug 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
3 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

May 11, 2026

Status Verified

April 1, 2026

Enrollment Period

3.9 years

First QC Date

May 4, 2026

Last Update Submit

May 4, 2026

Conditions

Vocal Tremor

Keywords

vocal tremorbotulinum toxinlaryngeal tremor

Outcome Measures

Primary Outcomes (1)

  • Change in Voice Handicap Index-10 (VHI-10)

    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.

    Baseline, 4 weeks

Study Arms (2)

Participants Receiving False Vocal Fold (FVF) Injection

ACTIVE COMPARATOR

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.

Procedure: False Vocal Fold (FVF) botulinum toxin injections

Participants Receiving Electromyography (EMG)-Guided Injection

ACTIVE COMPARATOR

Participants receive Electromyography (EMG)-guided botulinum toxin A injections into the TA/LCA muscles or equivalent targets per standard of care.

Procedure: Electromyography (EMG)-Guided Injection

Interventions

False Vocal Fold (FVF) botulinum toxin injectionsPROCEDURE

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.

Participants Receiving False Vocal Fold (FVF) Injection
Electromyography (EMG)-Guided InjectionPROCEDURE

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.

Participants Receiving Electromyography (EMG)-Guided Injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Related Publications (1)

  • Simpson CB, Lee CT, Hatcher JL, Michalek J. Botulinum toxin treatment of false vocal folds in adductor spasmodic dysphonia: Functional outcomes. Laryngoscope. 2016 Jan;126(1):118-21. doi: 10.1002/lary.25515. Epub 2015 Oct 15.

    PMID: 26467807BACKGROUND

Study Officials

  • Blake Simpson, MD

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Central Study Contacts

WayAnne Watson, MD

CONTACT

205-801-7801wayannewatson@gmail.com

Mollie Perryman, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 4, 2026

First Posted

May 11, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2030

Last Updated

May 11, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)