STN-DBS and the Risk of Sialorrhea

NCT06090929 | Completed

• 1 other identifier: DBS & drooling in PD
• Study Type: interventional
• Target: 234
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Deep Brain Stimulation; Sialorrhea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• DSFS score 36 months postoperatively

  36 months after STN-DBS

• BOTOX injection ratio 36 months postoperatively

  36 months after STN-DBS or a longer follow-up

Study Arms (2)

Patients with STN-DBS

EXPERIMENTAL

Patients accepted DBS implanted at the baseline

Device: STN-DBS

Patients without STN-DBS

NO INTERVENTION

Patients only accepted medication treatment before the end point

Interventions

STN-DBS DEVICE

STN-DBS was implanted according normal process

Patients with STN-DBS

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Chao Zhang

Jinan, Shandong, 250100, China

Location

Related Publications (1)

• Sun J, Cheng L, Li Z, Jia J, Wu Q, Hou Y, Wang Q, Zhang G, Wang H, Li X, Li W, Zhang C. Deep brain stimulation of the subthalamic nucleus increases the risk of sialorrhea in patients with advanced Parkinson's disease. Parkinsonism Relat Disord. 2024 Jun;123:106075. doi: 10.1016/j.parkreldis.2024.106075. Epub 2024 Mar 9.

  PMID: 38492517 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Sialorrhea

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Investigator was blinded to the status of DBS or non-DBS during the scoring of DRS, DSFS and drooling rate examination.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: October 7, 2023
• First Posted: October 19, 2023
• Study Start: January 1, 2019
• Primary Completion: January 1, 2022
• Study Completion: June 1, 2023
• Last Updated: October 19, 2023

Record last verified: 2023-10

Locations

CN (1)