STN-DBS is a Risk Factor of Sialorrhea in Patients With Advanced Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 1
- 主要终点
- DRS score 36 months postoperatively
研究概览
简要总结
OBJECTIVE: The aims of this study were to assess the incidence rate and risk factors for sialorrhea in the long-term follow-up in a cohort of 170 patients with advanced Parkinson's disease [84 with deep brain stimulation (DBS) and 86 on medical treatment].
Design, setting, and participants: This study was a multi-center prospective non-randomized concurrent clinical trial. A total of198 persons with Parkinson disease were referred for DBS between June 2019 and July 2021 and analyzed between June 2023 and July 2023.The primary outcome follow-up visit was conducted 36 months after DBS.
详细描述
IMPORTANCE: Sialorrhea is a frequent and disabling symptom in patients with PD. No prospective study has been specifically designed to test the effects of DBS on sialorrhea development.
OBJECTIVE
The aims of this study were to assess the incidence rate and risk factors for sialorrhea in the long-term follow-up in a cohort of 170 patients with advanced Parkinson's disease [84 with deep brain stimulation (DBS) and 86 on medical treatment].
Design, setting, and participants: This study was a multi-center prospective non-randomized concurrent clinical trial. A total of198 persons with Parkinson disease were referred for DBS between June 2019 and July 2021 and analyzed between June 2023 and July 2023.The primary outcome follow-up visit was conducted 36 months after DBS.
INTERVENTIONS: Bilateral subthalamic nucleus DBS was performed in one study arm and not performed in the other. Both arms of the study completed the drooling rating scale (DRS), the drooling severity and frequency scale (DSFS) and examination of salivary secretion rate.
MAIN OUTCOMES AND MEASURES: The primary outcome was the DRS scores of the patients with PD, with or without STN-DBS 36 months postoperatively. The secondary outcomes included the DSFS scores, saliva secreting rate, ratio of botox injection in different group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
盲法说明
Investigator was blinded to the status of DBS or non-DBS during the scoring of DRS, DSFS and drooling rate examination.
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Alzheimer's Disease
- •Age between 20 and 80 years
- •without drooling
- •swallowing function <5 on the Drooling Rate Scale (DRS).
- •Medications affecting drooling had to have stopped medications at least 4 weeks before study entry.
排除标准
- •Not he typical PD
- •Subjects on warfarin,
- •with significant medical illnesses or neuromuscular transmission disorders
- •past use of BoNT
- •-cognitive impairment (<23/30 on Mini Mental Status Exam) were excluded.
结局指标
主要结局
DRS score 36 months postoperatively
时间窗: 36 months after STN-DBS
Drooling Rate Scale (DRS) which range from 0 to 15 was used to evaluate the status of drooling. 0 stands for non-drooling and 15 stands for the severe status of drooling
次要结局
- DSFS score 36 months postoperatively(36 months after STN-DBS)
- BOTOX injection ratio 36 months postoperatively(36 months after STN-DBS or a longer follow-up)