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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03129087
Enrollment
20
Registered
2017-04-26
Start date
2017-05-23
Completion date
2019-05-01
Last updated
2018-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adductor Spasmodic Dysphonia

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.

Interventions

BEHAVIORALVocal rest versus vocalization

A comparison of one hour of vocal rest versus continuous vocalization after botulinum toxin injection

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

The proposed study is a randomized, cross-over, clinical trial involving the comparison of two treatments (A and B) separated by a wash-out period (W). The patient participants will be randomized to one of the following two treatment orders: AWB or BWA.

Eligibility

Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
No

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.)

Design outcomes

Primary

MeasureTime frameDescription
Severity of spasmodic dysphonia symptomsSix weeks post-treatmentAcoustic measures and perceptual ratings of vocal spasm severity
Patient-reported outcome measures of symptoms and communicationsix weeks post-treatmentSix patient-reported questionnaires related to symptoms, communication effectiveness, quality of life, and self-efficacy

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026