2-duct ligation versus botulinum toxin for severe drooling in children with cerebral palsy
- Conditions
- droolingsialorrhea10010335
- Registration Number
- NL-OMON37173
- Lead Sponsor
- niversitair Medisch Centrum Sint Radboud
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
- Age 6 years or above
- Cerebral palsy or other non-progressive neurological disease
- Severe drooling (Drooling Frequency >=3; Drooling Severity >=2)
- Conservative treatment has not led to adequate reduction of droolng
- Informed consent
- Cognitive ability of parents is adequate to participate in the study, as judged by the researchers.
- Participants are motived to return for follow up after 2, 8 and 32 weeks.
- Concurrent participation in other medical study
- Previous surgery or anatomical abnormalities that prohibit either application of botulinum toxin or surgery
- Concurrent other treatment for drooling
- Use of benzodiazepines
- Allergy to botulinum toxin or other contraindication for botulinumtoxin or surgery.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method