Botulinum Toxin for the Treatment of Involuntary Movement Disorders
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Neurology, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 4 - Any |
| Updated: | 3/17/2019 |
| Start Date: | November 21, 1985 |
| End Date: | October 30, 2019 |
| Contact: | Elaine P Considine, R.N. |
| Email: | considinee@ninds.nih.gov |
| Phone: | (301) 435-8518 |
A Training Protocol for the Use of Botulinum Toxin in the Treatment of Neurological Disorders
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.
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.
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. Patients can be in the study at any one time either for the
teaching value or for participation in other protocols, or both.
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. Patients can be in the study at any one time either for the
teaching value or for participation in other protocols, or both.
- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Bethesda, Maryland 20892
Phone: 800-411-1222
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