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Completed

NCT Number: NCT06090929

STN-DBS and the Risk of Sialorrhea

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.

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Key information

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chao Zhang

Jinan, Shandong, 250100, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

STN-DBS

Device

STN-DBS was implanted according normal process

Primary outcomes

  1. DRS score 36 months postoperatively

    Time frame: 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 outcomes

  1. DSFS score 36 months postoperatively

    Time frame: 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

  2. BOTOX injection ratio 36 months postoperatively

    Time frame: 36 months after STN-DBS or a longer follow-up

Sponsors and collaborators

Lead sponsor

Qilu Hospital of Shandong University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2023
First posted
Oct 19, 2023
Registry last updated
Oct 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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