Ethanol submandibular duct ligation for drooling in children with neurodisabilities - Ethanol 2-duct ligation

Radboudumc0 个研究点目标入组 5 人开始时间: 2021年7月30日最近更新: 2022年3月14日

适应症

试验速览

暂无简介。

•1.Moderate to severe drooling indicated by Drooling Frequency Score = 3 or Drooling Severity Score = 2.
•2.Aged 10 years and older.
•3.Cerebral palsy or any other non-progressive neurodevelopmental disability.
•4.Contra-indications for a SMDR, or rejection towards a SMDR by patient or caregiv-ers*
•5.Ability and willingness to follow the study protocol and attend the 8 and 32-weeks vis-its.
•6.Written and informed consent from caregivers, and when appropriate, oral consent from the child.
•* contra-indication for SMDR:
•- posterior drooling
•- pharyngeal dysphagia as judged by the speech and language therapist.
•- progressive neurodisability as judged by the child neurologist.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 5
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Medical history of salivary gland abnormalities like ductal stenosis, strictures
•2.Previous submandibular salivary gland surgery, or other contraindications for surgery or general anesthesia.
•3.Recent (<6 months) glandular Botulinum Neurotoxin A (BoNT-A) injection
•4.Simultaneous alternative treatment for drooling.

发起方