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STN-DBS and the Risk of Sialorrhea

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
STN-DBS
Sponsored by
Qilu Hospital of Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parkinson Disease focused on measuring Deep Brain Stimulation, Sialorrhea

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chao Zhang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Patients with STN-DBS

Patients without STN-DBS

Arm Description

Patients accepted DBS implanted at the baseline

Patients only accepted medication treatment before the end point

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
BOTOX injection ratio 36 months postoperatively

Full Information

First Posted
October 7, 2023
Last Updated
October 15, 2023
Sponsor
Qilu Hospital of Shandong University
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1. Study Identification

Unique Protocol Identification Number
NCT06090929
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2022 (Actual)
Study Completion Date
June 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Qilu Hospital of Shandong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Deep Brain Stimulation, Sialorrhea

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Masking
Investigator
Masking Description
Investigator was blinded to the status of DBS or non-DBS during the scoring of DRS, DSFS and drooling rate examination.
Allocation
Non-Randomized
Enrollment
234 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with STN-DBS
Arm Type
Experimental
Arm Description
Patients accepted DBS implanted at the baseline
Arm Title
Patients without STN-DBS
Arm Type
No Intervention
Arm Description
Patients only accepted medication treatment before the end point
Intervention Type
Device
Intervention Name(s)
STN-DBS
Intervention Description
STN-DBS was implanted according normal process
Primary Outcome Measure Information:
Title
DRS score 36 months postoperatively
Description
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 Outcome Measure Information:
Title
DSFS score 36 months postoperatively
Description
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
Title
BOTOX injection ratio 36 months postoperatively
Time Frame
36 months after STN-DBS or a longer follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Chao Zhang
City
Jinan
State/Province
Sichuan
ZIP/Postal Code
250100
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
individual participant data (IPD) could be available to other researchers on request without business benefits.

Learn more about this trial

STN-DBS and the Risk of Sialorrhea

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