Botulinum neurotoxin type A treatment for sialorrhea in central nervous system diseases

Tartu University Hospital0 个研究点目标入组 90 人开始时间: 2015年4月16日最近更新: 2018年12月4日

适应症

试验速览

暂无简介。

•BNT-A injections into salivary glands is used to treat patients suffering average and hard hypersalivation.
•The aetiology of sialorrhea is caused by chronic neurodegenerative diseases.
•The severity of sialorrhea is calculated using Item 2.2 from Part I (Non-Motor Aspects of Experiences of Daily Living) of the Unified Parkinson’s Disease Rating Scale (Goetz et al., 2008)
•The cases when logopedical treatment with chewing muscle and m. orbicularis oris myogymnastics do not decrease the saliva flow.
•The first control group participants are selected during routine dentist visits at Tartu University Hospital
•Requirement is that they have to be healthy human volunteers with the same age group.
•The second control group are selected during routine neurologist visits.
•Parkinson´s disease patients without sialorrhea. The severity of sialorrhea is calculated using Item 2.2 from Part I (Non-Motor Aspects of Experiences of Daily Living) of the Unified Parkinson’s Disease Rating Scale (Goetz et al., 2008)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 10
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 40

•During the study, no medication that could influence the severity of drooling is allowed.
•Patients with other sialorrhea treatment will be excluded from the study.

发起方