Vibrating Wand + Lidocaine for Spasmodic Dysphonia

Overseen By Richard Heyes, MBChB

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Mayo Clinic

Must be taking: Botox

Disqualifiers: Lidocaine allergy

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to make in-office treatments for spasmodic dysphonia (a voice disorder causing voice breaks and tightness) more comfortable. Researchers are testing two methods: a vibrating wand and lidocaine (a numbing medicine) to see if they help during Botox injections. One group will receive the injection with a vibrating wand, another with lidocaine, and a control group will receive the standard Botox injection. People with spasmodic dysphonia who already receive Botox treatment might be a good fit for this trial. As a Phase 2, Phase 3 trial, this research measures the treatment's effectiveness in an initial, smaller group and represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in treatment.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

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

In a previous study, patients who used a vibrating wand noticed consistent changes in their voice without major side effects. This suggests that the vibrating wand is well-tolerated for voice treatments.

Research on lidocaine, a common numbing medicine, has shown that it helps reduce symptoms like vocal strain and tightness in the voice box. These effects were reported without serious side effects, indicating that lidocaine is generally safe for voice procedures.

Both treatments appear to be safe options based on available data, showing few negative effects and good patient tolerance. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for spasmodic dysphonia because they offer innovative ways to enhance the standard Botox injection. The vibrating wand is unique because it may help reduce discomfort and anxiety by providing a soothing vibration during the procedure. On the other hand, lidocaine is being explored for its potential to numb the area before the Botox injection, possibly making the process more comfortable for patients. These methods could make Botox injections more pleasant and accessible, addressing common concerns about pain and discomfort.

What evidence suggests that the vibrating wand and lidocaine could be effective for spasmodic dysphonia?

Studies have shown that vibrating wands can noticeably improve voice quality for people with voice disorders. In one study, about 64% of participants noticed an improvement in their voice after using the device. In this trial, some participants will receive the standard laryngeal injection of Botox while using the vibrating wand. Research on lidocaine has shown it can significantly reduce symptoms like vocal strain and throat tightness. During lidocaine treatment, patients reported feeling less strain in their voices. Another group in this trial will receive a subcutaneous injection of lidocaine before the Botox injection. This trial studies both treatments to help make throat procedures more comfortable by reducing pain and improving voice quality. ^{1 2 4 5 6}

Who Is on the Research Team?

David Lott, MD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

Inclusion Criteria

You are currently getting Botox as a treatment through an approach involving the throat.

You have spasmodic dysphonia, with or without tremors in your voice.

Exclusion Criteria

You are allergic to lidocaine.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive three consecutive laryngeal injections of botulinum toxin with different anesthesia methods in a randomized order

6 months

Multiple visits for each injection session

Follow-up

Participants are monitored for pain levels and subject preference after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Lidocaine
• Vibrating wand

How Is the Trial Designed?

Group I: Vibrating Wand Experimental Treatment 1 Intervention

Patients will receive standard of care laryngeal injection of Botox via a transcricothyroid approach while using the vibrating wand.

Group II: Lidocaine Experimental Treatment 1 Intervention

Patients will receive standard of care laryngeal injection of Botox via a transcricothyroid approach following subcutaneous injection of lidocaine (approximately 2 minutes before Botox injection).

Group III: Control Active Control 1 Intervention

Patients will receive standard of care laryngeal injection of Botox via a transcricothyroid approach without additional anesthesia

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Published Research Related to This Trial

Topical administration of lidocaine can lead to serious toxicity, as demonstrated in a case where a patient experienced neurological issues (convulsions) and cardiological problems (ventricular fibrillation) during a thyroplasty procedure.

Despite the severe reactions, the patient's condition improved satisfactorily, highlighting the importance of monitoring for potential side effects even with local anesthetics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Toxicity of topical administration of lidocaine]. Gómez Martín-Zarco, JM., Lumbreras Fernández de Córdoba, J., Ortiz García, P.[2019]

In a study involving 12 subjects, Xylocaine (lidocaine aerosol 10%) and lidocaine 4% were found to be effective for providing topical anesthesia to the tympanic membrane, with significant pain reduction observed 25 minutes after application.

Lidocaine hydrochloride 5% was ineffective, likely due to its ionized form, which suggests that the un-ionized state of lidocaine is crucial for its anesthetic efficacy, and no side effects were reported during the trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Topical anaesthesia of the normal tympanic membrane: a controlled clinical trial of different suspensions of lidocaine. Møller, A., Grøntved, A.[2018]

A study involving eight healthy volunteers revealed significant variability in serum lidocaine concentrations after using a topical aerosol spray, with a 14-fold difference in peak levels from identical doses, indicating unpredictable absorption rates.

The use of cimetidine, a medication that affects drug metabolism, was found to increase the overall exposure to lidocaine, suggesting that caution should be exercised when using standard doses of topical lidocaine due to the risk of serious adverse effects like seizures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Serum lidocaine concentrations following application to the oropharynx: effects of cimetidine. Parish, RC., Gotz, VP., Lopez, LM., et al.[2019]

Lidocaine hydrochloride is the most commonly used anesthetic in dermatology, and adverse reactions are very rare, primarily consisting of vasovagal responses and local effects like bruising and swelling.

This report highlights an extremely rare case of a true type I hypersensitivity allergy to lidocaine, which is believed to account for only 1% of all adverse reactions to this anesthetic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case reports: type I hypersensitivity to lidocaine. Haugen, RN., Brown, CW.[2013]

Viscous lidocaine can pose a high risk of overdose in pediatric patients due to their altered pharmacokinetics, making doses safe for adults potentially toxic for children.

Benzocaine is recommended as a safer alternative for treating painful mouth lesions in children, as it has a lower incidence of side effects, but if lidocaine must be used, clear and specific dosing instructions should be provided to parents.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lidocaine overdose: another preventable case? Gonzalez del Rey, J., Wason, S., Druckenbrod, RW.[2019]

Citations

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/16585864/

Lidocaine block of the recurrent laryngeal nerve in ...

Results: During the block, patients reported significant reductions on overall severity (P = .045), vocal effort (P < .001), and laryngeal tightness (P = .002).

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researchgate.net/publication/7193997_Lidocaine_Block_of_the_Recurrent_Laryngeal_Nerve_in_Adductor_Spasmodic_Dysphonia_A_Multidimensional_Assessment

Lidocaine Block of the Recurrent Laryngeal Nerve in ...

During the block, patients reported significant reductions on overall severity (P = .045), vocal effort (P < .001), and laryngeal tightness (P = ...

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Transnasal Endoscopic Injection of Botulinum Toxin in ...

-Significant decrease in the number of voice breaks and sentence length. -No significant change in aperiodicity and fundamental frequency. -All patients ...

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emedicine.medscape.com/article/864079-treatment

Spasmodic Dysphonia Treatment & Management

Outcome and Prognosis​​ These adverse effects disappear within the first week, but voice improvement persists for approximately 12 weeks. ...

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journals.physiology.org

journals.physiology.org/doi/10.1152/japplphysiol.00087.2004

Correspondence between laryngeal vocal fold movement ...

The first step in examining this hypothesis is to determine whether vocal fold movement is closely related to intrinsic laryngeal muscle activation. If this is ...

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clinconnect.io

clinconnect.io/trials/NCT07154628

Effect of Topical Lidocaine Spraying on the Vocal Cords

This clinical trial is looking at whether spraying a numbing medicine called lidocaine on the vocal cords before placing a breathing tube during ...