Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT03616067
Eligibility Criteria:
Inclusion Criteria:
* Aged 4 to 18 years old,
* Cerebral palsy with pathological drooling,
* Significant impact of drooling on the children (DIS score ≥40),
* Affiliated or beneficiary of a social security scheme,
* At least one of the parents understanding and speaking French,
* Written consent form signed by both parents
Exclusion Criteria:
* Previous history of surgery for drooling,
* Injection of botulinum toxin (all locations) in the 3 months prior to the inclusion,
* Treatment by scopolamine patch (Scopoderm®) or other anticholinergic (Artane®, etc.) in the month prior to inclusion,
* Contraindication to the anesthetic or sedation,
* Contraindication to one of the treatments studied (glaucoma, myastenia),
* Swallowing disorder (to saliva) or absence of spontaneous swallowing reflex not investigated by nasoscopy
* On-going or programmed orthodontic treatment over the study period.
* Untreated oro-mandibular dystonia (isolated lingual dystonia accepted)
* Untreated bruxism
* Untreated clinical gastro esophageal reflux
* Untreated dental inflammatory condition (dental caries, gingivitis…)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
18 Years
Study:
NCT03616067
Study Brief:
Protocol Section:
NCT03616067