STN-DBS and the Risk of Sialorrhea

STN-DBS is a Risk Factor of Sialorrhea in Patients With Advanced Parkinson's Disease

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: STN-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.

• Study Type: Interventional
• Enrollment (Actual): 234
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Sichuan
    • Jinan, Sichuan, China, 250100
      • Chao Zhang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients with STN-DBS; Patients accepted DBS implanted at the baseline	Device: STN-DBS; STN-DBS was implanted according normal process
No Intervention: Patients without STN-DBS; Patients only accepted medication treatment before the end point

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	36 months after STN-DBS

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	36 months after STN-DBS
BOTOX injection ratio 36 months postoperatively		36 months after STN-DBS or a longer follow-up

Collaborators and Investigators

• Sponsor: Qilu Hospital of Shandong University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): January 1, 2022
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: October 7, 2023
• First Submitted That Met QC Criteria: October 15, 2023
• First Posted (Actual): October 19, 2023

Study Record Updates

• Last Update Posted (Actual): October 19, 2023
• Last Update Submitted That Met QC Criteria: October 15, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Deep Brain Stimulation; Sialorrhea
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stomatognathic Diseases; Mouth Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Salivary Gland Diseases; Parkinson Disease; Sialorrhea
• Other Study ID Numbers: DBS & drooling in PD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: individual participant data (IPD) could be available to other researchers on request without business benefits.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No