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NCT Number: NCT06858176

Research on the Brain Glymphatic System of Parkinson's Disease Patients Based on DTI Technology

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.

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Key information

Age range

30 year–82 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

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

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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Treatment and study plan

No intervention was implemented in this observational study

Other

No intervention was implemented in this observational study

Primary outcomes

  1. DTI-ALPS

    Time frame: After stopping the medication for 12 hours

Sponsors and collaborators

Lead sponsor

The First People's Hospital of Yunnan

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 5, 2025
Registry last updated
Mar 5, 2025

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

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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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