Vocal TremorNCT07577310
False Vocal Fold vs EMG Guided Botox for Vocal Tremor
A study testing False Vocal Fold (FVF) botulinum toxin injections and Electromyography (EMG)-Guided Injection in people with Vocal Tremor, run by University of Alabama at Birmingham at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vocal Tremor
- What is being tested?
- False Vocal Fold (FVF) botulinum toxin injections and Electromyography (EMG)-Guided Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2026to Jul 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mollie Perryman, MD contact
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
WayAnne Watson, MD, 205-801-7801, wayannewatson@gmail.com
Mollie Perryman, MD, 205-801-7801, mcperryman@uabmc.edu
About this study
Official title: False Vocal Fold vs EMG-Guided Botulinum Toxin Injections for Voice Tremor (FVFIVT): Prospective Non-Randomized Comparative Clinical Trial
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
- Being tested
- False Vocal Fold (FVF) botulinum toxin injections, Electromyography (EMG)-Guided Injection
- Keywords
- vocal tremor, botulinum toxin, laryngeal tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
False Vocal Fold (FVF) botulinum toxin injectionsProcedure or surgery
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 InjectionProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Electromyography (EMG)-Guided Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study startAug 2026 (estimated)
- Primary completionJul 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vocal TremorStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Blake Simpson, University of Alabama at Birmingham
- Investigators
- Blake Simpson, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577310
- Sponsor's protocol ID
- IRB-300015963
- Other IDs
- UAB
- Status last verified
- Apr 2026
- First submitted
- 4 May 2026
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26467807
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- False Vocal Fold vs EMG-Guided Botulinum Toxin Injections for Voice Tremor (FVFIVT): Prospective Non-Randomized Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT07577310
- Acronym / sponsor ID
- IRB-300015963
- Conditions
- Vocal Tremor
- Keywords
- vocal tremor, botulinum toxin, laryngeal tremor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Jul 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants Receiving False Vocal Fold (FVF) Injection | Active comparator | Procedure: False Vocal Fold (FVF) botulinum toxin injectionsParticipants 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. |
| Participants Receiving Electromyography (EMG)-Guided Injection | Active comparator | Procedure: Electromyography (EMG)-Guided InjectionParticipants receive Electromyography (EMG)-guided botulinum toxin A injections into the TA/LCA muscles or equivalent targets per standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| False Vocal Fold (FVF) botulinum toxin injectionsFalse 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 or surgery | Participants Receiving False Vocal Fold (FVF) Injection |
| Electromyography (EMG)-Guided InjectionEMG-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. | Procedure or surgery | Participants Receiving Electromyography (EMG)-Guided Injection |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Background: PubMed 26467807Simpson 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mollie Perryman, MD contact
Blake Simpson, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing False Vocal Fold (FVF) botulinum toxin injections and Electromyography (EMG)-Guided Injection in people with Vocal Tremor, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact WayAnne Watson, MD (205-801-7801, wayannewatson@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Voice Handicap Index-10 (VHI-10) (time frame: Baseline, 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07577310, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026; AzTrials last refreshed its copy on 1 Nov 2026.