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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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
3,298 Previous Clinical Trials
3,958,413 Total Patients Enrolled
William Karle, MDPrincipal InvestigatorMayo Clinic
David Lott, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
10 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to lidocaine.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.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Vibrating Wand
- Group 3: Lidocaine
Awards:
This trial has 2 awards, including:- 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.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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