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Clinical Trials/NCT03129087
NCT03129087
Unknown
Not Applicable

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

Lawson Health Research Institute1 site in 1 country20 target enrollmentMay 23, 2017
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ConditionsAdductor Spasmodic Dysphonia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Adductor Spasmodic Dysphonia
Sponsor
Lawson Health Research Institute
Enrollment
20
Locations
1
Primary Endpoint
Severity of spasmodic dysphonia symptoms
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 23, 2017
End Date
May 1, 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.)

Outcomes

Primary Outcomes

Severity of spasmodic dysphonia symptoms

Time Frame: Six weeks post-treatment

Acoustic measures and perceptual ratings of vocal spasm severity

Patient-reported outcome measures of symptoms and communication

Time Frame: six weeks post-treatment

Six patient-reported questionnaires related to symptoms, communication effectiveness, quality of life, and self-efficacy

Study Sites (1)

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