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临床试验/NCT00895063
NCT00895063终止不适用

Effect of Vocal Exercise After Botulinum Toxin Injection for Spasmodic Dysphonia

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 8 人开始时间: 2007年12月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
8
试验地点
1
主要终点
Self-rating of vocal function

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • other neurological disorder
  • other dystonia
  • upper respiratory infection in the last two weeks
  • analgesia at time of injection
  • under 18 years of age

结局指标

主要结局

Self-rating of vocal function

时间窗: Baseline, 2 weeks, 6 weeks, 3 months

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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