STN-DBS and the Risk of Sialorrhea

Sponsor

Qilu Hospital of Shandong University (Other)

Overall Status

Completed

CT.gov ID

NCT06090929

Collaborator

(none)

234

Enrollment

Location

Arms

Actual Duration (Months)

4.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease	Device: STN-DBS	N/A

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.

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 Design

Study Type:

Interventional

Actual Enrollment :

234 participants

Allocation:

Non-Randomized

Intervention Model:

Crossover Assignment

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)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:

Single (Investigator)

Masking Description:

Investigator was blinded to the status of DBS or non-DBS during the scoring of DRS, DSFS and drooling rate examination.

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Jan 1, 2022

Actual Study Completion Date :

Jun 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

DRS score 36 months postoperatively [36 months after STN-DBS]
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 [36 months after STN-DBS]
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 [36 months after STN-DBS or a longer follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chao Zhang	Jinan	Sichuan	China	250100

Sponsors and Collaborators

Qilu Hospital of Shandong University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Qilu Hospital of Shandong University

ClinicalTrials.gov Identifier:

NCT06090929

Other Study ID Numbers:

DBS & drooling in PD

First Posted:

Oct 19, 2023

Last Update Posted:

Oct 19, 2023

Last Verified:

Oct 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Qilu Hospital of Shandong University

Deep Brain Stimulation

Sialorrhea

Additional relevant MeSH terms:

Sialorrhea

Parkinson Disease

Study Results

No Results Posted as of Oct 19, 2023