Cerebral Palsy, Drooling
Conditions
Keywords
cerebral palsy, drooling, botulinum toxin
Brief summary
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
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.
Interventions
Sponsors
National Science and Technology Council, Taiwan
National Taiwan University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
6 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the effectiveness of botulinum toxin in treatment of drooling | — |
Secondary
| Measure | Time frame |
|---|---|
| the most appropriated dosage of treatment | — |
| duration of effect | — |
| side effects | — |
Countries
Taiwan
Contacts
Primary ContactJern Yi Shieh, MD
Backup ContactPey Yu Yang, MD
Outcome results
None listed