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:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT07069257
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of cerebral palsy (unilateral/bilateral spastic, ataxic, dyskinetic, or mixed type)
* Presence of drooling control problems
* Age between 4 and 17 years
* Gross Motor Function Classification System (GMFCS) levels 2, 3, 4, or 5
* Stable drooling severity for at least one month prior to enrollment
* Drooling Severity and Frequency Scale (DSFS) score of 3 or higher
Exclusion Criteria:
* Diagnosis of dysphagia
* Use of medications affecting drooling within the past 72 hours
* Upper respiratory tract infection and/or salivary gland infection during the study period
* History of botulinum toxin injection to the salivary glands
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
17 Years
Study:
NCT07069257
Study Brief:
Protocol Section:
NCT07069257