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Botulinum Toxin for the Treatment of Involuntary Movement Disorders

This study is currently recruiting patients.

Sponsored by: National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: Warren G Magnuson Clinical Center (CC)

Purpose

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.

Condition Treatment or Intervention
Chorea
Drug Induced Dyskinesia
Movement Disorder
Muscular Disease
Tic Disorder
 Drug: Botulinum Toxin

MedlinePlus related topics:  Mental Health;   Movement Disorders;   Muscle Disorders

Study Type: Interventional
Study Design: Training

Official Title: A Training Protocol for the use of Botulinum Toxin in the Treatment of Neurological Disorders

Further Study Details: 

Expected Total Enrollment:  800

Study start: November 21, 1985

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 physiology of dystonia, and other muscle spasms and physiological effects of botulinum toxin.

Eligibility

Genders Eligible for Study:  Both

Criteria

INCLUSION CRITERIA:
Patients will be eligible for participation if they have a movement disorder that, in the judgment of the treating physician, might be amenable to treatment with botulinum toxin.
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, spasmodic dysphonia with or without prior recurrent laryngeal nerve resection or thyroplasty.
EXCLUSION CRITERIA:
Patients will be excluded form participation if
1. They are pregnant or breastfeeding.
2. They have a known motor neuron or neuromuscular junction disease (amyothropic lateral sclerosis, myasthenia gavis, Eaton-Lamert Syndrome).
3. They require treatment with an aminoglycoside antibiotic.
4. They have a paradoxical vocal fold movement with intermittent stridor due to either gastroesophageal reflux or emotional disorders.

Location and Contact Information


Maryland
      National Institute of Neurological Disorders and Stroke (NINDS), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting
Patient Recruitment and Public Liaison Office  1-800-411-1222    prpl@mail.cc.nih.gov 
TTY  1-866-411-1010 

More Information

Detailed Web Page

Publications

Hott JS, Dalakas MC, Sung C, Hallett M, Youle RJ. Skeletal muscle-specific immunotoxin for the treatment of focal muscle spasm. Neurology. 1998 Feb;50(2):485-91.

Karp BI, Cole RA, Cohen LG, Grill S, Lou JS, Hallett M. Long-term botulinum toxin treatment of focal hand dystonia. Neurology. 1994 Jan;44(1):70-6.

Ludlow CL, Hallett M, Rhew K, Cole R, Shimizu T, Sakaguchi G, Bagley JA, Schulz GM, Yin SG, Koda J. Therapeutic use of type F botulinum toxin. N Engl J Med. 1992 Jan 30;326(5):349-50. No abstract available.

Study ID Numbers:  850195; 85-N-0195
Record last reviewed:  November 20, 2003
Last Updated:  November 20, 2003
Record first received:  November 3, 1999
ClinicalTrials.gov Identifier:  NCT00001208
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08
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