STN-DBS and the Risk of Sialorrhea

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06090929
• Other study ID #: DBS & drooling in PD
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: June 1, 2023

Study information

• Verified date: October 2023
• Source: Qilu Hospital of Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 234
• Est. completion date: June 1, 2023
• Est. primary completion date: January 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Sialorrhea

Intervention

Device:
• STN-DBS
STN-DBS was implanted according normal process

Locations

Country	Name	City	State
China	Chao Zhang	Jinan	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Qilu Hospital of Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	BOTOX injection ratio 36 months postoperatively		36 months after STN-DBS or a longer follow-up