Parkinson Disease
Conditions
Keywords
Deep Brain Stimulation, Sialorrhea
Brief summary
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.
Detailed description
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.
Interventions
DEVICESTN-DBS
STN-DBS was implanted according normal process
Sponsors
Qilu Hospital of Shandong University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Masking description
Investigator was blinded to the status of DBS or non-DBS during the scoring of DRS, DSFS and drooling rate examination.
Intervention model description
A total of 234 participants were enrolled between June 2019 and July 2021; 198 patients with PD receive STN-DBS (n=99) or medication (n=99)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DRS score 36 months postoperatively | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| DSFS score 36 months postoperatively | 36 months after STN-DBS | drooling severity scale (DSFS) which range from 0 to 5 was used to evaluate the status of drooling. 0 stands for non-drooling and 5 stands for the severe status of drooling |
| BOTOX injection ratio 36 months postoperatively | 36 months after STN-DBS or a longer follow-up | — |
Countries
China
Outcome results
None listed