Treatment of Drooling With Type A Botulinum Toxin in Children With Cerebral Palsy

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of botulinum toxin injection to treat drooling in children with cerebral palsy, and to find the most appropriate dosage, duration of effect and side effects.

Detailed Description
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Sialorrhea, or drooling, has been reported to be a significant problem in 10%to 37% of patients with cerebral palsy. Excessive drooling may cause skin maceration, increased the burden of caregiver, affect articulation of the patients, and increase the risk of aspiration and dehydration. Many options, including various therapies, medications, surgeries and radiation, have been proposed to treat drooling. Yet none of these is universally successful and many have potential complications. Nerve endings of the parasympathetic post-ganglionic neurons secret aceylcholine. Botulinum toxin should be able to inhibit salivary gland secretion by blocking the release of acetylcholine. Very limited case series had proved fair result of botulinum toxin injection to treat drooling. However, most of the subjects were adult patients with neurological disorders. The purpose of this study is to evaluate the effectiveness of botulinum toxin injection to treat drooling in children with cerebral palsy, and to find the most appropriate dosage, duration of effect and side effects.

Official Title
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Treatment of Drooling With Type A Botulinum Toxin A in Children With Cerebral Palsy

Conditions
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Cerebral Palsy, Drooling

Intervention / Treatment
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* Drug: botulinum toxin A injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: diagnosis of cerebral palsy severe drooling aged 6-21 yrs subjects (or their guardian) who are able to understand the requirements of the study and sign the informed consent form Exclusion Criteria: age below 6 yrs or above 21 yrs known allergy or sensitivity to the study medication or its component diagnosis of myasthenia gravis, amyotrophic lateral sclerosis or any other disease that might interfere with neuromuscular function subjects who have prior surgery of the submandibular gland subjects who are receiving medication that affect drooling such as anticholinergic drug inability to give informed consent

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: botulinum toxin A injection|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the effectiveness of botulinum toxin in treatment of drooling |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the most appropriated dosage of treatment |  |  | 
| duration of effect |  |  | 
| side effects |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cerebral palsy, drooling, botulinum toxin