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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with STN-DBS | Experimental | Patients accepted DBS implanted at the baseline |
|
| Patients without STN-DBS | No Intervention | Patients only accepted medication treatment before the end point |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STN-DBS | Device | STN-DBS was implanted according normal process |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| BOTOX injection ratio 36 months postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chao Zhang | Jinan | Shandong | 250100 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38492517 | Derived | 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. |
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individual participant data (IPD) could be available to other researchers on request without business benefits.
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D012798 | Sialorrhea |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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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)
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Investigator was blinded to the status of DBS or non-DBS during the scoring of DRS, DSFS and drooling rate examination.
| 36 months after STN-DBS or a longer follow-up |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |