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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

85-N-0195

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 4
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

None

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 Keyword(s)

Movement Disorders

Condition(s)

Chorea;
Drug Induced Dyskinesia;
Movement Disorder;
Muscular Disease;
Tic Disorder

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Other: Botulinum Toxin

Supporting Site

National Institute of Neurological Disorders and Stroke

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.<TAB>

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Eligibility

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. Women who are planning on becoming pregnant, 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.


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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

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Contacts:

Principal Investigator

Referral Contact

For more information:

Debra J. Ehrlich, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10 RM 7D37
10 CENTER DR
BETHESDA MD 20814
(301) 443-7888
debra.ehrlich@nih.gov

Elaine P. Considine, R.N.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 7D36
10 Center Drive
Bethesda, Maryland 20892
(301) 435-8518
considinee@ninds.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT00001208

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