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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

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 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

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

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,307 Previous Clinical Trials
2,962,367 Total Patients Enrolled
William Karle, MDPrincipal InvestigatorMayo Clinic
David Lott, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
10 Total Patients Enrolled

Media Library

Vibrating wand Clinical Trial Eligibility Overview. Trial Name: NCT04648891 — Phase 2 & 3
Spasmodic Dysphonia Research Study Groups: Control, Vibrating Wand, Lidocaine
Spasmodic Dysphonia Clinical Trial 2023: Vibrating wand Highlights & Side Effects. Trial Name: NCT04648891 — Phase 2 & 3
Vibrating wand 2023 Treatment Timeline for Medical Study. Trial Name: NCT04648891 — Phase 2 & 3
~8 spots leftby Oct 2025