An interventional study of STN-DBS in Parkinson Disease, sponsored by Qilu Hospital of Shandong University. Completed at 1 site in China. Open to participants aged 20 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-19.
Sponsored by Qilu Hospital of Shandong University · Not applicable, Interventional, and Prevention
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.
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.
4,573 studies on the registry are indexed under Parkinson Disease; 1,086 are open to participants now.
This study's enrollment of 234 is above the median of 40 across 3,353 interventional studies indexed under Parkinson Disease.
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Exclusion Criteria:
Patients accepted DBS implanted at the baseline
Device: STN-DBS
Patients only accepted medication treatment before the end point
STN-DBS was implanted according normal process
DRS score 36 months postoperatively
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
Time frame: 36 months after STN-DBS
DSFS score 36 months postoperatively
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
Time frame: 36 months after STN-DBS
BOTOX injection ratio 36 months postoperatively
Time frame: 36 months after STN-DBS or a longer follow-up
Plan to share: Undecided — individual participant data (IPD) could be available to other researchers on request without business benefits.
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Qilu Hospital of Shandong University →