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Botulinum Toxin for the Treatment of Involuntary Movement Disorders

This study is currently recruiting participants.
Study NCT00001208.   Last updated on July 18, 2008.   Information provided by National Institutes of Health Clinical Center (CC)

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Descriptive Information Fields
Brief Title  Botulinum Toxin for the Treatment of Involuntary Movement Disorders
Official Title  A Training Protocol for the Use of Botulinum Toxin in the Treatment of Neurological Disorders
Brief Summary

Botulism is a severe form of food poisoning caused by bacteria. This bacteria produces several toxins one of which is botulinum toxin A. This toxin causes the symptoms of food poisoning. Small amounts of botulinum toxin A have been used to treat speech disorders such as stuttering and problems with the muscles of the eyes.

The study examines the effectiveness of botulinum toxin as treatment for a variety of movement disorders. The goals of the study are to refine the technique of treatment to provide the best results, to improve the understanding of how botulinum toxin works on movement disorders, and find other conditions that may be treatable with botulinum toxin.

In addition, researchers also plan to study the possible use of botulinum toxin F alone and in combination with botulinum toxin A in patients who do not respond to botulinum A toxin treatment. ...

Detailed Description

The efficacy of botulinum toxin (btx) has now been demonstrated for a variety of diseases associated with involuntary muscle spasms or movement. The application of botulinum toxin therapy to movement disorders requires treatment tailored to the individual patient and specific techniques of injection. This protocol 1) provides for training of physicians in the use of botulinum toxin and 2) allows us to provide botulinum toxin injections for patients participating in other studies on the physiology of sensorimotor systems and physiological effects of botulinum toxin.

Study Phase
Study Type  Observational
Study Design 
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Chorea
Drug Induced Dyskinesia
Movement Disorder
Muscular Disease
Tic Disorder
Intervention 
MEDLINE PMIDs 9484377,   8290095,   1728750
Links NIH Clinical Center Detailed Web Page This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  1000
Start Date  November 1985
Completion Date
Eligibility Criteria 
  • INCLUSION CRITERIA:

Patients will be eligible for participation if they have a disorder that, in the judgment of the treating physician, might be amenable to treatment with BTX.

Applicable disorders include but are not limited to dystonia, hemifacial spasm, blepharospasm, tremor, spasmodic dysphonia, tics, vocal fold tremor, oral lingual dyskinesia, tardive dyskinesia, spasticity, and spasmodic dysphonia.

EXCLUSION CRITERIA:

Patients will be excluded form participation if

  1. They are pregnant or breastfeeding, for the duration of the condition.
  2. They require treatment with an aminoglycoside antibiotic, until treatment is complete.
  3. For laryngeal injections, they have a paradoxical vocal fold movement with intermittent stridor due to either gastroesophageal reflux or emotional disorders.
Gender Both
Ages
Accepts Healthy Volunteers No
Contacts ††
Contact: Patient Recruitment and Public Liaison Office     (800) 411-1222     prpl@mail.cc.nih.gov    
Contact: TTY     1-866-411-1010        
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00001208
Organization ID 850195
Secondary IDs †† 85-N-0195
Study Sponsor  National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators ††
Investigators 
Information Provided By National Institutes of Health Clinical Center (CC)
Verification Date November 2007
First Received Date  November 3, 1999
Last Updated Date July 18, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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