Botox for Vocal Tremor

WW
MP
Overseen ByMollie Perryman, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University of Alabama at Birmingham
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores two methods of using Botox to assist individuals with essential voice tremor, a condition causing uncontrollable voice shaking. Participants will receive Botox injections either into the false vocal folds or through electromyography (EMG) guidance, which uses tiny electrical signals to target specific muscles. The trial aims to determine which method improves quality of life, reduces tremor severity, and increases patient satisfaction. Individuals diagnosed with essential voice tremor who can communicate in English may be suitable candidates. As an unphased trial, this study provides an opportunity to contribute to innovative research that could lead to better treatment options for essential voice tremor.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that botulinum toxin injections are generally well-tolerated for treating voice tremors. Research indicates that injections into the false vocal folds provide similar voice quality and satisfaction as other injection sites. Studies also report that doctors perform over 1,700 of these injections each month, suggesting they are widely accepted and considered safe in the medical community.

Research supports the safe use of EMG-guided injections for managing voice tremors. Studies highlight the importance of accurately targeting the injections to minimize side effects. Overall, both injection methods have a good safety record for treating voice issues with botulinum toxin. While side effects can occur, they are usually mild and manageable.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for vocal tremor because they offer new ways to deliver botulinum toxin A, a common treatment for muscle-related conditions. The False Vocal Fold (FVF) injection involves an endoscopic-guided method, allowing precise delivery directly to the false vocal folds, which could enhance effectiveness and personalization by tailoring dosing and laterality to each patient's needs. On the other hand, the Electromyography (EMG)-guided injection targets the TA/LCA muscles, using electrical activity to guide the injection, potentially improving accuracy and outcomes compared to traditional methods. These innovative delivery techniques might provide better symptom control and more customized treatment plans for individuals with vocal tremor.

What evidence suggests that this trial's treatments could be effective for essential voice tremor?

This trial will compare two methods of botulinum toxin injections for managing essential voice tremor. Participants receiving False Vocal Fold (FVF) injections will undergo endoscopic-guided Onabotulinum toxin A injections to the false vocal folds. Studies have indicated that FVF injections improve voice quality and control tremors as effectively as traditional methods, with patients reporting better voice sound and fewer issues like breathiness and choking. Participants receiving Electromyography (EMG)-guided injections will have botulinum toxin A injected into the TA/LCA muscles or equivalent targets. Evidence supports the effectiveness of EMG-guided injections in improving voice quality and reducing tremor severity. Both methods have decreased the effort needed to speak and improved overall satisfaction with the voice. Overall, botulinum toxin treatments have consistently shown promise in managing voice tremor symptoms.12678

Who Is on the Research Team?

BS

Blake Simpson, MD

Principal Investigator

University of Alabama at Birmingham

Are You a Good Fit for This Trial?

This trial is for people with essential voice tremor who want to improve their voice quality. Participants will be chosen based on a discussion between them and their doctor, but specific inclusion or exclusion criteria are not listed.

Inclusion Criteria

Age ≥18 years
I have been diagnosed with essential voice tremor by specialists.
I am considered suitable for FVF or EMG-guided botulinum toxin injections.
See 1 more

Exclusion Criteria

Coexisting severe neurologic disease that precludes reliable participation in follow-up
I have had throat surgery or a condition that affects tremor evaluation.
Known hypersensitivity to botulinum toxin or injectable components
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either false vocal fold (FVF) or EMG-guided botulinum toxin injections based on shared clinical decision-making

4 weeks

Follow-up

Participants are monitored for changes in voice-related quality of life, tremor severity, and patient satisfaction

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • EMG-Guided Injection
  • False Vocal Fold (FVF) botulinum toxin injections

Trial Overview

The study compares two ways of giving botulinum toxin (Botox) injections for vocal tremor: one targets the false vocal folds, and the other uses EMG guidance. Patients get one of these treatments and are followed for 12 weeks to see which works better.

How Is the Trial Designed?

2

Treatment groups

Active Control

Group I: Participants Receiving False Vocal Fold (FVF) InjectionActive Control1 Intervention
Group II: Participants Receiving Electromyography (EMG)-Guided InjectionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials
1,677
Recruited
2,458,000+

Citations

Voice Tremor and Botulinum Neurotoxin Therapy - PMC - NIH

An updated review of the literature detailing the current understanding of voice tremor (with or without essential tremor), its accurate diagnosis and targeted ...

False Vocal Fold vs EMG Guided Botox for Vocal Tremor

The study will assess changes in voice-related quality of life, tremor severity, and patient satisfaction over a 12-week follow-up period and ...

Laryngeal dystonia and vocal tremor response to botulinum ...

The main objective of this study was to compare laryngeal dystonia (LD) and vocal tremor's (VT) response to botulinum toxin injection.

4.

scholarsarchive.byu.edu

scholarsarchive.byu.edu/facpub/7281/

"Botulinum Toxin for Essential Tremor of the Voice With ...

A reduction in vocal effort appeared to be coincident with reduction in laryngeal airway resistance after BO-TOX injection. Conclusions: Using objective ...

Outcomes of Onabotulinum Toxin A Treatment for Adductor ...

All 548 patients benefited from onabotulinum toxin A; the mean number of days with a good voice was higher for patients with adductor spasmodic dysphonia (81 ...

Short-Interval Botulinum Toxin Chemodenervation in ...

This cohort study aims to determine the proportion and characteristics of patients who receive botulinum toxin chemodenervation treatment in ...

Botulinum Toxin for the Treatment of Tremors

In this review, we discuss the available randomized controlled trials and open-label evidence for the use of BoNT in various tremor etiologies, as well as its ...

Response to Comments: Botulinum Toxin Injections

Individualizing treatment is crucial for optimizing outcomes, provided it stays within established safety limits. Adhering to these guidelines ensures that ...