STN-DBS and the Risk of Sialorrhea

Qilu Hospital of Shandong University234 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Parkinson Disease

Interventions

STN-DBSDEVICE

STN-DBS was implanted according normal process

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Chao Zhang

Jinan, Shandong, China

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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