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Effect of Vocal Exercise After Botulinum Toxin Injection for Spasmodic Dysphonia

Primary Purpose

Spasmodic Dysphonia, Dystonia

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vocal Exercise
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spasmodic Dysphonia focused on measuring Spasmodic Dysphonia, Botulinum Toxin, Vocal Exercise

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Private Practice of Dr. Andrew Blitzer

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Vocal Exercise

Silence

Arm Description

Subject will speak continually for one hour following injection of botulinum toxin.

Subject will remain silent for one hour following injection of botulinum toxin.

Outcomes

Primary Outcome Measures

Self-rating of vocal function

Secondary Outcome Measures

Full Information

First Posted
May 6, 2009
Last Updated
March 2, 2016
Sponsor
NYU Langone Health
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT00895063
Brief Title
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

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Terminated
Study Start Date
December 2007 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
Allergan

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spasmodic Dysphonia, Dystonia
Keywords
Spasmodic Dysphonia, Botulinum Toxin, Vocal Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Vocal Exercise
Arm Type
Experimental
Arm Description
Subject will speak continually for one hour following injection of botulinum toxin.
Arm Title
Silence
Arm Type
Placebo Comparator
Arm Description
Subject will remain silent for one hour following injection of botulinum toxin.
Intervention Type
Behavioral
Intervention Name(s)
Vocal Exercise
Other Intervention Name(s)
Botulinum toxin, BOTOX, BTX, BoNT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Self-rating of vocal function
Time Frame
Baseline, 2 weeks, 6 weeks, 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Celia F Stewart, Ph.D.
Organizational Affiliation
New York University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Private Practice of Dr. Andrew Blitzer
City
New York
State/Province
New York
ZIP/Postal Code
10036
Country
United States

12. IPD Sharing Statement

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Effect of Vocal Exercise After Botulinum Toxin Injection for Spasmodic Dysphonia

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