STN-DBS and the Risk of Sialorrhea

Shandong University

Status: Completed

Conditions: Parkinson Disease

Treatments: Device: STN-DBS

Study type: Interventional

Funder types: Other

Identifiers

NCT06090929

DBS & drooling in PD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 234 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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234 participants in 2 patient groups

Patients with STN-DBS

Experimental group

Description:

Patients accepted DBS implanted at the baseline

Treatment:

Device: STN-DBS

Patients without STN-DBS

No Intervention group

Description:

Patients only accepted medication treatment before the end point