Glymphatic SystemNCT06858176
Research on the Brain Glymphatic System of Parkinson's Disease Patients Based on DTI Technology
An observational study of Glymphatic System and Parkinson's Disease (PD), run by The First People's Hospital of Yunnan.
Trial summary
Synopsis：The brain glymphatic system is a newly discovered anatomical system for removing waste products and maintaining homeostasis in the brain, and its damage is closely related to a variety of neurological diseases. Read more about this study
- Who is it for?
- Ages 30 to 82 years
- Conditions the study is for
- Glymphatic System, Parkinson's Disease (PD), DTI
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to Apr 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 30 to 82 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The clinical data of 100 patients with primary Parkinson's disease will be admitted to the First People's Hospital of Yunnan Province from March 2025 to April 2026 were prospectively collected, and they will be divided into two groups: 50 patients with early Parkinson's disease and 50 patients with late Parkinson's disease according to the Hoehn-Yahr Scale , and 50 healthy volunteers (HC) matched with them will be collected.
Inclusion Criteria:(1) All the selected candidates were diagnosed in accordance with the "Diagnostic Criteria for Parkinson's Disease in China" (2016 edition) formulated by the International Society of Parkinson's Disease and Movement Disorders and the Parkinson's Disease and Movement Disorders Group and Special Committee of China; (2) Able to cooperate with and tolerate cranial magnetic resonance examination; (3) All are effective against dopamine drugs.
- Exclusion Criteria:(1) secondary parkinsonism (such as after encephalitis, long-term use of neuroleptics such as phenothiazines and butyryls and other drugs such as reserpine, history of toxic exposure, history of vascular diseases such as cerebral infarction or hemorrhage in the basal ganglia, history of traumatic brain injury, abnormal thyroid function, etc.); (2) Parkinson's superposition syndrome (such as progressive supranuclear palsy, olivine pontine cerebellar atrophy, corticobasal ganglia degeneration, Lewy body dementia, Shv. Dräger syndrome, etc.); (3) hereditary degenerative parkinsonism; (4) Patients with diabetes mellitus and end-stage renal disease; (5) Those with contraindications to magnetic resonance examination.
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About this study
Synopsis：The brain glymphatic system is a newly discovered anatomical system for removing waste products and maintaining homeostasis in the brain, and its damage is closely related to a variety of neurological diseases. The diffusion tensor image-analysis along the perivascular space (DTI-ALPS) technique has the advantage of being non-invasive and has been shown to be useful for assessing brain glymphatic system function. The purpose of this study is to use DTI-ALPS technology to evaluate the functional changes of the brain glymphatic system in patients with primary Parkinson's disease at different stages of the disease .
Impact:DTI-ALPS technology is a potential imaging indicator for early diagnosis and monitoring of Parkinson's disease progression, and has definite value for clinical application.
Purpose :the functional changes of brain glymphatic system in patients with Parkinson's disease at different stages of the disease will be investigated based on DTI-ALPS technology Methods:The clinical data of 100 patients with primary Parkinson's disease will be admitted to the First People's Hospital of Yunnan Province from March 2025 to April 2026 wil be prospectively collected, and they will be divided into two groups: 50 patients with early Parkinson's disease and 50 patients with late Parkinson's disease according to the Hoehn-Yahr Scale , and 50 healthy volunteers (HC) matched with them will be collected. All subjects will be scanned with a 3.0 T MRI system（MAGNETOM Prisma,Siemens Healthcare,Erlangen,Germany）.The scanning sequences included conventional MRI noncontrast and DTI sequences, which acquired images of b=0 s/mm² and b=1000 s/mm²4. FSL and ITK-SANP software will be used to delineate circular ROIs with voxel diameters of 5 mm in the projection fiber and contact fiber regions at the bilateral ventricular body level of the anisotropy score map, and the diffusivity of each fiber on the x, y, and z axes will be measured, and the DTI-ALPS index value will be calculated, and the one-way ANOVA wii be performed by IBM SPSS statistic 25.0 software, and the differences in the mean ALPS values of the left brain, right brain, and both sides of the subjects in the three groups will be compared. The correlation between the index and clinical data such as age, course of disease, Mini-Mental State Examination Score (MMSE), Montreal Cognitive Assessment Scale, Quality of Life Questionnaire for Patients with Parkinson's Disease (PDQ-39), Parkinson's Disease Non-motor Symptom Evaluation Scale (NMSS), Hamilton Depression Rating Scale score(HAMD), and Unified Parkinson's Rating Scale score (URPDS)will be analyzed.
- Conditions
- Glymphatic System, Parkinson's Disease (PD), DTI
- Being tested
- No intervention was implemented in this observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention was implemented in this observational studyOther
No intervention was implemented in this observational study
| Study group | Role | What they receive |
|---|---|---|
| patients with early Parkinson's disease and late Parkinson's disease and healthy volunteer | Not described Receives: Other: No intervention was implemented in this observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
DTI-ALPS
Measured: After stopping the medication for 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionMar 2026 (estimated)
- Study completionApr 2026 (estimated)
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 Glymphatic SystemStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Yunnan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Sa, The First People's Hospital of Yunnan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858176
- Sponsor's protocol ID
- KHLL2025-KY049
- Status last verified
- Feb 2025
- First submitted
- 27 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sa L, Li S, Chen L, Wang J, Wang Y, Cheng C, Xin C, Zhang S, Ding F, Wang B. Association Between Glymphatic Dysfunction and Anxiety in Parkinson's Disease: Insights from DTI-ALPS and Choroid Plexus Volume. Neuropsychiatr Dis Treat. 2026 Jan 27;22:568398. doi: 10.2147/NDT.S568398. eCollection 2026.
PubMed 41867702
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Brain Glymphatic System of Parkinson's Disease Patients Based on DTI Technology
- ClinicalTrials.gov ID
- NCT06858176
- Acronym / sponsor ID
- KHLL2025-KY049
- Conditions
- Glymphatic System, Parkinson's Disease (PD), DTI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- The First People's Hospital of YunnanUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Apr 2026 (estimated)
- First posted
- 5 Mar 2025 (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.
Synopsis：The brain glymphatic system is a newly discovered anatomical system for removing waste products and maintaining homeostasis in the brain, and its damage is closely related to a variety of neurological diseases. The diffusion tensor image-analysis along the perivascular space (DTI-ALPS) technique has the advantage of being non-invasive and has been shown to be useful for assessing brain glymphatic system function. The purpose of this study is to use DTI-ALPS technology to evaluate the functional changes of the brain glymphatic system in patients with primary Parkinson's disease at different stages of the disease .
Impact:DTI-ALPS technology is a potential imaging indicator for early diagnosis and monitoring of Parkinson's disease progression, and has definite value for clinical application.
Purpose :the functional changes of brain glymphatic system in patients with Parkinson's disease at different stages of the disease will be investigated based on DTI-ALPS technology Methods:The clinical data of 100 patients with primary Parkinson's disease will be admitted to the First People's Hospital of Yunnan Province from March 2025 to April 2026 wil be prospectively collected, and they will be divided into two groups: 50 patients with early Parkinson's disease and 50 patients with late Parkinson's disease according to the Hoehn-Yahr Scale , and 50 healthy volunteers (HC) matched with them will be collected. All subjects will be scanned with a 3.0 T MRI system（MAGNETOM Prisma,Siemens Healthcare,Erlangen,Germany）.The scanning sequences included conventional MRI noncontrast and DTI sequences, which acquired images of b=0 s/mm² and b=1000 s/mm²4. FSL and ITK-SANP software will be used to delineate circular ROIs with voxel diameters of 5 mm in the projection fiber and contact fiber regions at the bilateral ventricular body level of the anisotropy score map, and the diffusivity of each fiber on the x, y, and z axes will be measured, and the DTI-ALPS index value will be calculated, and the one-way ANOVA wii be performed by IBM SPSS statistic 25.0 software, and the differences in the mean ALPS values of the left brain, right brain, and both sides of the subjects in the three groups will be compared. The correlation between the index and clinical data such as age, course of disease, Mini-Mental State Examination Score (MMSE), Montreal Cognitive Assessment Scale, Quality of Life Questionnaire for Patients with Parkinson's Disease (PDQ-39), Parkinson's Disease Non-motor Symptom Evaluation Scale (NMSS), Hamilton Depression Rating Scale score(HAMD), and Unified Parkinson's Rating Scale score (URPDS)will be analyzed.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with early Parkinson's disease and late Parkinson's disease and healthy volunteer | – | Other: No intervention was implemented in this observational study |
Who may qualify
- Ages
- 30 to 82 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The clinical data of 100 patients with primary Parkinson's disease will be admitted to the First People's Hospital of Yunnan Province from March 2025 to April 2026 were prospectively collected, and they will be divided into two groups: 50 patients with early Parkinson's disease and 50 patients with late Parkinson's disease according to the Hoehn-Yahr Scale , and 50 healthy volunteers (HC) matched with them will be collected.
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 |
|---|---|---|
| No intervention was implemented in this observational studyNo intervention was implemented in this observational study | Other | patients with early Parkinson's disease and late Parkinson's disease and healthy volunteer |
Primary outcome
DTI-ALPS
Time frame: After stopping the medication for 12 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Derived from this study: PubMed 41867702Sa L, Li S, Chen L, Wang J, Wang Y, Cheng C, Xin C, Zhang S, Ding F, Wang B. Association Between Glymphatic Dysfunction and Anxiety in Parkinson's Disease: Insights from DTI-ALPS and Choroid Plexus Volume. Neuropsychiatr Dis Treat. 2026 Jan 27;22:568398. doi: 10.2147/NDT.S568398. eCollection 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Glymphatic System and Parkinson's Disease (PD), run by The First People's Hospital of Yunnan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
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?
DTI-ALPS (time frame: After stopping the medication for 12 hours). 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 NCT06858176, 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 5 Mar 2025.