Parkinson DiseaseNCT06090929
STN-DBS and the Risk of Sialorrhea
A study testing STN-DBS in people with Parkinson Disease, run by Qilu Hospital of Shandong University at 1 site in China.
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]. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- STN-DBS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 234 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2019to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: STN-DBS is a Risk Factor of Sialorrhea in Patients With Advanced Parkinson's Disease
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.
Read the detailed 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.
- Conditions
- Parkinson Disease
- Being tested
- STN-DBS
- Keywords
- Deep Brain Stimulation, Sialorrhea
- Medical subject headings
- Parkinson Disease, Sialorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STN-DBSDevice
STN-DBS was implanted according normal process
| Study group | Role | What they receive |
|---|---|---|
| Patients with STN-DBS | Experimental | Patients accepted DBS implanted at the baseline Receives: Device: STN-DBS |
| Patients without STN-DBS | No intervention | Patients only accepted medication treatment before the end point |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 36 months after STN-DBS
Secondary outcomes (2)
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
Measured: 36 months after STN-DBS
BOTOX injection ratio 36 months postoperatively
Measured: 36 months after STN-DBS or a longer follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2023
- Study start1 Jan 2019
- Primary completion1 Jan 2022
- Study completion1 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- 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)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 234 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06090929
- Sponsor's protocol ID
- DBS & drooling in PD
- Status last verified
- Oct 2023
- First submitted
- 7 Oct 2023
- Last updated
- 19 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: individual participant data (IPD) could be available to other researchers on request without business benefits.
Publications
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.
PubMed 38492517
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STN-DBS is a Risk Factor of Sialorrhea in Patients With Advanced Parkinson's Disease
- ClinicalTrials.gov ID
- NCT06090929
- Acronym / sponsor ID
- DBS & drooling in PD
- Conditions
- Parkinson Disease
- Keywords
- Deep Brain Stimulation, Sialorrhea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 234 participants (actual)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 19 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- 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)
| Arm | Type | Receives |
|---|---|---|
| Patients with STN-DBS | Experimental | Device: STN-DBSPatients accepted DBS implanted at the baseline |
| Patients without STN-DBS | No intervention | –Patients only accepted medication treatment before the end point |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| STN-DBSSTN-DBS was implanted according normal process | Device | Patients with STN-DBS |
Primary outcome
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
2 secondary outcomes
DSFS score 36 months postoperatively
Time frame: 36 months after STN-DBS
BOTOX injection ratio 36 months postoperatively
Time frame: 36 months after STN-DBS or a longer follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2023.
- Derived from this study: PubMed 38492517Sun 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.
- Individual participant dataSharing planned: Undecided. individual participant data (IPD) could be available to other researchers on request without business benefits.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STN-DBS in people with Parkinson Disease, run by Qilu Hospital of Shandong University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DRS score 36 months postoperatively (time frame: 36 months after STN-DBS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06090929, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2023.