Effect of Vocal Exercise After Botulinum Toxin Injection for Spasmodic Dysphonia
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Spasmodic Dysphonia Dystonia |
Behavioral: Vocal Exercise |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effect of Vocal Exercise After Botulinum Toxin Injection for Spasmodic Dysphonia |
- Self-rating of vocal function [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months ] [ Designated as safety issue: No ]
- Number of voice breaks during connected speech [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months ] [ Designated as safety issue: No ]
- Duration of voice onset time in speech [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | December 2007 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Vocal Exercise
Subject will speak continually for one hour following injection of botulinum toxin.
|
Behavioral: Vocal Exercise
This project will examine whether or not exercise performed immediately following botulinum toxin injection affects the clinical benefit received from the injection. This is a cross-over study and subjects will be randomly assigned to a group where they will speak continually for one hour or remain silent for one hour following injection. Data on the effectiveness of the exercise will be collected just before each injection and at 2 weeks, 6 weeks, and 3 months following injection.
Other Names:
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Placebo Comparator: Silence
Subject will remain silent for one hour following injection of botulinum toxin.
|
Behavioral: Vocal Exercise
This project will examine whether or not exercise performed immediately following botulinum toxin injection affects the clinical benefit received from the injection. This is a cross-over study and subjects will be randomly assigned to a group where they will speak continually for one hour or remain silent for one hour following injection. Data on the effectiveness of the exercise will be collected just before each injection and at 2 weeks, 6 weeks, and 3 months following injection.
Other Names:
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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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- diagnosis of adductor spasmodic dysphonia
- receiving ongoing botulinum toxin injections for a minimum of 1 year
- improvement in voice to at least 70% following each of the last three injections
Exclusion Criteria:
- other neurological disorder
- other dystonia
- upper respiratory infection in the last two weeks
- analgesia at time of injection
- illiterate
- under 18 years of age
Contacts and Locations| Contact: Celia F Stewart, Ph.D. | 2122397411 | cs8@nyu.edu |
| United States, New York | |
| Private Practice of Dr. Andrew Blitzer | Recruiting |
| New York, New York, United States, 10036 | |
| Contact: Celia F Stewart, Ph.D. 212-998-5262 cs8@nyu.edu | |
| Principal Investigator: Celia F Stewart, Ph.D. | |
| Principal Investigator: | Celia F Stewart, Ph.D. | New York University |
More Information
No publications provided
| Responsible Party: | Celia Stewart/Chair and Associate Professor, New York University |
| ClinicalTrials.gov Identifier: | NCT00895063 History of Changes |
| Other Study ID Numbers: | BOTOXEX |
| Study First Received: | May 6, 2009 |
| Last Updated: | July 26, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New York University School of Medicine:
|
Spasmodic Dysphonia Botulinum Toxin Vocal Exercise |
Additional relevant MeSH terms:
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Dystonia Dystonic Disorders Dysphonia Dyskinesias Neurologic Manifestations Nervous System Diseases Signs and Symptoms Movement Disorders Central Nervous System Diseases |
Voice Disorders Laryngeal Diseases Respiratory Tract Diseases Otorhinolaryngologic Diseases Botulinum Toxins Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013