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Vibrating Wand + Lidocaine for Spasmodic Dysphonia

Phase 2 & 3

Waitlist Available

Led By William Karle, MD

Research Sponsored by Mayo Clinic

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

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.

Eligible Conditions

Spasmodic Dysphonia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain Experienced

Secondary study objectives

Subject Preference

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Vibrating WandExperimental Treatment1 Intervention

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

Group II: LidocaineExperimental Treatment1 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: ControlActive Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Vibrating wand

2021

Completed Phase 3

~40

Lidocaine

FDA approved