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Effect of Vocal Exercise After Botulinum Toxin Injection for Spasmodic Dysphonia

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2011 by New York University School of Medicine
Sponsor:
Collaborator:
Allergan
Information provided by:
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00895063
First received: May 6, 2009
Last updated: July 26, 2011
Last verified: July 2011
  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

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Self-rating of vocal function [ Time Frame: Baseline, 2 weeks, 6 weeks, 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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:
  • Botulinum toxin
  • BOTOX
  • BTX
  • BoNT
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:
  • Botulinum toxin
  • BOTOX
  • BTX
  • BoNT

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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00895063

Contacts
Contact: Celia F Stewart, Ph.D. 2122397411 cs8@nyu.edu

Locations
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.         
Sponsors and Collaborators
New York University School of Medicine
Allergan
Investigators
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:
Voice Disorders
Dysphonia
Laryngeal Diseases
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Signs and Symptoms
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014