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

Lawson Health Research Institute

Status: Unknown

Conditions: Adductor Spasmodic Dysphonia

Treatments: Behavioral: Vocal rest versus vocalization

Study type: Interventional

Funder types: Other

Identifiers

NCT03129087

LawsonHRI2

Details and patient eligibility

About

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

Enrollment: 20 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

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.)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Vocal activity

Experimental group

Description:

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

Treatment:

Behavioral: Vocal rest versus vocalization

Vocal rest

Experimental group

Description:

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

Treatment:

Behavioral: Vocal rest versus vocalization