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

Not Applicable

• Conditions: Adductor Spasmodic Dysphonia
• Interventions: Behavioral: Vocal rest versus vocalization

• Registration Number: NCT03129087
• Lead Sponsor: Lawson Health Research Institute

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-19
• Study First Submitted QC: 2017-04-21
• Study First Posted: 2017-04-26
• Study Start: 2017-05-23
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-08-16
• Primary Completion: 2019-05-01
• Study Completion: 2019-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Vocal activity	Vocal rest versus vocalization	The vocal activity arm will require the participant to remain in the clinic and read aloud continuously for a period of one hour after a botulinum toxin injection
Vocal rest	Vocal rest versus vocalization	The vocal rest arm will require the participant to remain in the clinic and remain on complete vocal rest for a period of one hour after a botulinum toxin injection

Primary Outcome Measures

Name	Time	Method
Severity of spasmodic dysphonia symptoms	Six weeks post-treatment	Acoustic measures and perceptual ratings of vocal spasm severity
Patient-reported outcome measures of symptoms and communication	six weeks post-treatment	Six patient-reported questionnaires related to symptoms, communication effectiveness, quality of life, and self-efficacy

Trial Locations

Locations (1)

LawsonHRI; 🇨🇦 London, Ontario, Canada