The Effect of Vocal Rest Versus Vocalization Following Xeomin® Injections in Spasmodic Dysphonia

Adductor Spasmodic Dysphonia Clinical Trial

Official title:

The Effect of Vocal Rest Versus Vocalization Following Xeomin® Injections in Spasmodic Dysphonia

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03129087
• Other study ID #: LawsonHRI2
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 23, 2017
• Est. completion date: May 1, 2019

Study information

• Verified date: August 2018
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will compare the effects of vocal rest versus continuous vocalization for one hour immediately following botulinum toxin injections for adductor spasmodic dysphonia.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: May 1, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosed with adductor spasmodic dysphonia (ADSD) by an experienced neurologist and otolaryngologist. ADSD patients who have been stabilized on their treatment dose for at least 2 treatment cycles.

Exclusion Criteria:

• Diagnosed with another neurological disorder that is combined with ADSD (i.e. Parkinson's disease and ADSD). Previous history of an additional vocal pathology (i.e. vocal polps, vocal nodules, unilateral vocal fold paralysis, etc.)

Related Conditions & MeSH terms

• Adductor Spasmodic Dysphonia
• Dysphonia
• Hoarseness

Intervention

Behavioral:
• Vocal rest versus vocalization
A comparison of one hour of vocal rest versus continuous vocalization after botulinum toxin injection

Locations

Country	Name	City	State
Canada	LawsonHRI	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of spasmodic dysphonia symptoms	Acoustic measures and perceptual ratings of vocal spasm severity	Six weeks post-treatment
Primary	Patient-reported outcome measures of symptoms and communication	Six patient-reported questionnaires related to symptoms, communication effectiveness, quality of life, and self-efficacy	six weeks post-treatment