Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
234 participants
INTERVENTIONAL
2019-01-01
2023-06-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
DBS Frequency on Swallowing Function in Parkinson's Disease
NCT01935011
Physical Therapy and Deep Brain Stimulation in Parkinson Disease
NCT03181282
Frequency Effect of STN-DBS Through the Dual System on FOG in PD
NCT04285099
Non-invasive Measurement of Brain Oxygen Levels in People With Subthalamic Deep Brain Stimulators
NCT02278406
Impact of Frequency-specific Subthalamic Nucleus Subregion Stimulation on Inhibitory Control in Parkinson's Disease
NCT07022522
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
CROSSOVER
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients with STN-DBS
Patients accepted DBS implanted at the baseline
STN-DBS
STN-DBS was implanted according normal process
Patients without STN-DBS
Patients only accepted medication treatment before the end point
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
STN-DBS
STN-DBS was implanted according normal process
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
20 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Qilu Hospital of Shandong University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Chao Zhang
Jinan, Shandong, China
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sun J, Cheng L, Li Z, Jia J, Wu Q, Hou Y, Wang Q, Zhang G, Wang H, Li X, Li W, Zhang C. Deep brain stimulation of the subthalamic nucleus increases the risk of sialorrhea in patients with advanced Parkinson's disease. Parkinsonism Relat Disord. 2024 Jun;123:106075. doi: 10.1016/j.parkreldis.2024.106075. Epub 2024 Mar 9.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DBS & drooling in PD
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.