Clinical trial NCT00895063: Effect of Vocal Exercise After Botulinum Toxin Injection for Spasmodic Dysphonia
Official title: Effect of Vocal Exercise After Botulinum Toxin Injection for Spasmodic Dysphonia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spasmodic Dysphonia
Dystonia
Keywords: Spasmodic Dysphonia
Botulinum Toxin
Vocal Exercise
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Allergan
First posted: 2009-05-07
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Studies have suggested that voluntary muscle exercise in the hand and face after botulinum toxin injection may enhance the clinical effects of the toxin. Exercise may speed up the absorption of the toxin by the nerves and enhance the clinical response. This study will explore the effect of exercise on botulinum toxin injections for spasmodic dysphonia (SD).

Detailed description: SD is a rare voice disorder that usually starts when individuals are in early adulthood and occurs in two common forms: adductor and abductor (Aronson, 1968, Brin et al., 1992, Schweinfurth et al., 2002). Adductor is the more common form (Aronson, 1985, Blitzer et al. 1998). With adductor SD, patients have been described as "trying to talk whilst being choked" (Critchley, 1939). The spasmodic hyperadduction of the vocal folds is associated with strained-strangled, rough voice quality and sudden intermittent voice arrests (Aminoff, Dedo, \& Izdebski, 1978, Blitzer \& Brin, 1992, Hillel, 2001, Izdebski 1992, Ludlow, Nauton, \& Bassich, 1984, Woodson, Zwirner, Murry, \& Swenson, 1991). On the other hand, the intermittent or continuous abduction of the vocal folds linked with abductor SD results in breathy or whispered voice quality with sudden intermittent voice arrests (Aronson, 1985, Hillel, 2001, and Zwitman, 1979).

Local injection of botulinum toxin is an effective treatment for spasmodic dysphonia and The National Academies of Otolaryngology and Neurology has endorsed the toxin as the treatment of choice for adductor spasmodic dysphonia. Consequently, this treatment is widely used. The clinical benefit of the botulinum toxin is related to muscle weakness in the vocal folds and the benefit lasts from 6 weeks to 6 months.

Studies have suggested that voluntary muscle exercise in the hand and face after botulinum toxin injection may enhance the clinical effects of the toxin (Chen, Scott, \& Smith, 2002; Chen et al., 1999; Kim et. al 2003;. Exercise may speed up the absorption of the toxin by the nerves and enhance the clinical response. You are invited to take part in a research study to learn more about the effect of exercise on botulinum toxin injections for spasmodic dysphonic. This project will examine whether or not exercise performed immediately following botulinum toxin injection affects the clinical benefit received from the injection.

Eligibility criteria: Inclusion Criteria:

1. diagnosis of adductor spasmodic dysphonia
2. receiving ongoing botulinum toxin injections for a minimum of 1 year
3. improvement in voice to at least 70% following each of the last three injections

Exclusion Criteria:

1. other neurological disorder
2. other dystonia
3. upper respiratory infection in the last two weeks
4. analgesia at time of injection
5. illiterate
6. under 18 years of age

Primary outcomes:
measure: Self-rating of vocal function
timeFrame: Baseline, 2 weeks, 6 weeks, 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Private Practice of Dr. Andrew Blitzer
state: New York
Study officials:
affiliation: New York University
name: Celia F Stewart, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: