Clinical trial NCT06090929: STN-DBS and the Risk of Sialorrhea
Official title: STN-DBS is a Risk Factor of Sialorrhea in Patients With Advanced Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Deep Brain Stimulation
Sialorrhea
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2023-10-19
Enrollment: 234
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
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)
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: DRS score 36 months postoperatively
timeFrame: 36 months after STN-DBS
Secondary outcomes:
measure: DSFS score 36 months postoperatively
timeFrame: 36 months after STN-DBS
measure: BOTOX injection ratio 36 months postoperatively
timeFrame: 36 months after STN-DBS or a longer follow-up
Other outcomes:
Locations:
city: Jinan
country: China
facility: Chao Zhang
state: Sichuan
Study officials:
References: