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Vibrating Wand + Lidocaine for Spasmodic Dysphonia
N/A
Recruiting
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 baseline, 3 months, 6 months
Awards & highlights
Study Summary
This trial is testing different ways to make patients more comfortable during in-office laryngology procedures.
Eligible Conditions
- Spasmodic Dysphonia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 3 months, 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in pain experienced
Trial Design
3Treatment groups
Experimental Treatment
Group I: Vibrating WandExperimental Treatment1 Intervention
Patients will receive laryngeal injection of Botox via a transcricothyroid approach while a vibrating instrument is held adjacent to cricothyroid space
Group II: LidocaineExperimental Treatment1 Intervention
Patients will receive laryngeal injection of Botox via a transcricothyroid approach following subcutaneous injection of 0.5cc 2% lidocaine in 1:100,000 epinephrine (done approximately 2 minutes before Botox injection)
Group III: ControlExperimental Treatment1 Intervention
Patients will receive laryngeal injection of Botox via a transcricothyroid approach without additional anesthesia
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lidocaine
FDA approved
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,207 Previous Clinical Trials
3,767,090 Total Patients Enrolled
William Karle, MDPrincipal InvestigatorMayo Clinic
David Lott, MDPrincipal InvestigatorMayo Clinic
1 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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