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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06090929
Other study ID # DBS & drooling in PD
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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