Effect of Vocal Exercise After Botulinum Toxin Injection for Spasmodic Dysphonia

NCT00895063 | Terminated DMC

• 1 other identifier: BOTOXEX
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Spasmodic Dysphonia; Dystonia

Keywords

Spasmodic Dysphonia; Botulinum Toxin; Vocal Exercise

Outcome Measures

Primary Outcomes (1)

• Self-rating of vocal function

  Baseline, 2 weeks, 6 weeks, 3 months

Study Arms (2)

Vocal Exercise

EXPERIMENTAL

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

Behavioral: Vocal Exercise

Silence

PLACEBO COMPARATOR

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

Behavioral: Vocal Exercise

Interventions

Vocal Exercise BEHAVIORAL

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.

Also known as: Botulinum toxin, BOTOX, BTX, BoNT

Silence; Vocal Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• NYU Langone Health: lead
• Allergan: collaborator

Study Sites (1)

Private Practice of Dr. Andrew Blitzer

New York, New York, 10036, United States

Location

MeSH Terms

Conditions

Dysphonia; Dystonia

Interventions

Botulinum Toxins; Botulinum Toxins, Type A

Condition Hierarchy (Ancestors)

Voice Disorders; Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Dyskinesias

Intervention Hierarchy (Ancestors)

Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Celia F Stewart, Ph.D.

  New York University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2009
• First Posted: May 7, 2009
• Study Start: December 1, 2007
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: March 3, 2016

Record last verified: 2016-03

Locations

US (1)