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

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing two methods to reduce pain during throat injections for patients with spasmodic dysphonia. The methods include a numbing medicine and a vibrating device. The numbing medicine works by stopping pain signals, while the vibrating device confuses the pain signals to make them less noticeable. Botulinum toxin injection is a common treatment for spasmodic dysphonia, providing temporary relief from symptoms.

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 the combination of a vibrating wand and lidocaine generally safe for humans?

Lidocaine is generally safe for adults when used correctly, but there are risks of overdose, especially in children, and rare allergic reactions. Topical use can sometimes lead to serious side effects like seizures, so caution is advised with its use. ^{1 2 3 4 5}

How does the Vibrating Wand + Lidocaine treatment differ from other treatments for spasmodic dysphonia?

The Vibrating Wand + Lidocaine treatment is unique because it combines a physical therapy approach (vibrating wand) with a topical anesthetic (lidocaine) to potentially relax the laryngeal muscles, unlike the standard botulinum toxin injections that directly target muscle spasms. This combination may offer a non-invasive alternative to injections, focusing on muscle relaxation and pain relief. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Vibrating Wand + Lidocaine for Spasmodic Dysphonia?

Lidocaine has been used in procedures involving the recurrent laryngeal nerve to assess its effects on voice function in spasmodic dysphonia, suggesting its potential role in treatment. Additionally, other treatments like botulinum toxin have shown improvement in voice quality for similar conditions, indicating that targeting muscle activity can be effective. ^{9 10 11 12 13}

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

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Chiropractic care for a patient with spasmodic dysphonia associated with cervical spine trauma. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Lidocaine block of the recurrent laryngeal nerve in adductor spasmodic dysphonia: a multidimensional assessment. [2013]

3. United States pubmed.ncbi.nlm.nih.gov

Recurrent layngeal nerve section for spasmodic dysphonia. [2017]

4. England pubmed.ncbi.nlm.nih.gov

Botulinum toxin therapy of laryngeal muscle hyperactivity syndromes: comparing different botulinum toxin preparations. [2015]

5. United States pubmed.ncbi.nlm.nih.gov

Liquid-type Botulinum Toxin Type A in Adductor Spasmodic Dysphonia: A Prospective Pilot Study. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Lidocaine overdose: another preventable case? [2019]

7. Spain pubmed.ncbi.nlm.nih.gov

[Toxicity of topical administration of lidocaine]. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

Serum lidocaine concentrations following application to the oropharynx: effects of cimetidine. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Case reports: type I hypersensitivity to lidocaine. [2013]

11. United States pubmed.ncbi.nlm.nih.gov

Laryngeal Botulinum Toxin Injection: Can It Be a Cause of Obstructive Sleep Apnea as an Adverse Effect? [2022]

12. United States pubmed.ncbi.nlm.nih.gov

Double-blind controlled study of botulinum toxin in adductor spasmodic dysphonia. [2010]

13. United States pubmed.ncbi.nlm.nih.gov

Management of supraglottic squeeze in adductor spasmodic dysphonia: a new technique. [2013]