Protocol Number: 85-N-0195

Title:

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

Number:

85-N-0195

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.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Active Accrual Of New Subjects

Gender: Male & Female

Referral Letter Required: Yes

Population Exclusion(s): None

Eligibility 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.

Special Instructions:

The referring physician should send a letter and pertinent information to our research contact. Patients who may be suitable to participate in the protocol will have further evaluation in our Human Motor Control Clinic.

Keywords:

Spasmodic Torticollis

Writer's Cramp

Spasmodic Dysphonia

Stuttering

Oromandibular Dystonia

Palatal Myoclonus

Dystonia

Essential Tremor

Recruitment Keywords:

Movement Disorders

Conditions:

Chorea

Drug Induced Dyskinesia

Movement Disorder

Muscular Disease

Tic Disorder

Investigational Drug(s):

None

Investigational Device(s):

None

Contacts:

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citations:

Skeletal muscle-specific immunotoxin for the treatment of focal muscle spasm

Long-term botulinum toxin treatment of focal hand dystonia

Therapeutic use of type F botulinum toxin

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Networks and Applications, CC.

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Warren Grant Magnuson Clinical Center (CC)
National Institutes of Health (NIH)
Bethesda, Maryland 20892. Last update: 10/15/2004