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Clinical study of early diagnosis of Parkinson's disease based on substantia nigra-striatal axis multimodal imaging

Clinical study of early diagnosis of Parkinson's disease based on substantia nigra-striatal axis multimodal imaging

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2000038937
Enrollment
Unknown
Registered
2020-10-10
Start date
2020-11-01
Completion date
Unknown
Last updated
2021-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson's disease

Interventions

etc.),&#32
Gold Standard:Clinical diagnosis by experienced movement disorder specialists after 2 years of follow-up.
imaging&#32
(SUVR&#32
high-dimensional&#32

Sponsors

Huashan Hospital, Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 80 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria for patients with early PD: (1) Age between 45 and 80 years old; gender is not limited. (2) Patients meet PD diagnostic criteria (2015 version of PD diagnostic guidelines developed by the International Society for Movement Disorders MDS), early patients (H&Y grade 1). (3) Brain MRI supports the diagnosis of PD, and there is no evidence of other neurological diseases. (4) If you take drugs related to PD treatment, the drugs used to improve the clinical symptoms of PD must be maintained at a stable dose for more than 30 days before starting this study. (5) A written informed consent form must be signed by the subject or his legal guardian or caregiver. (6) If necessary, the subject can be accompanied by a nursing staff. (7) Before any assessment, the subject or his legal representative understands and signs a written informed consent. (8) Female subjects must have medical records to prove that they have passed surgical sterilization (such as hysterectomy, bilateral ovarian resection, or fallopian tube ligation) or have been menopausal for more than one year; if they are still able to conceive, they must be isolated during this research phase Contraception. (9) Male subjects must take isolation contraceptive measures during this research phase. Male subjects are not allowed to donate sperm during this study. (10) 18F-FDG and 11C-CFT PET, ultrasonography (TCS), multi-sequence MRI and clinical evaluation were performed in Huashan Hospital within 2 years. (11) Willing and able to cooperate with all projects of this research. Inclusion criteria for RBD patients: (1) Age between 45 and 80 years old; gender is not limited. (2) The patient must be confirmed by polysomnography (PSG) that he meets the diagnostic criteria for loss of muscle tension during REM sleep and meets at least one of the following: 1) A history of harmful or potentially harmful motor symptoms; 2) PSG synchronized video recording recorded the patient's complex movement behavior during REM sleep. Brain MRI supports the diagnosis of PD, and there is no evidence of other neurological diseases. (3) Brain MRI has no evidence of other neurological diseases. (4) If you take RBD treatment-related drugs, the drugs used to improve the clinical symptoms of RBD must be maintained at a stable dose for more than 30 days before starting this study. (5) A written informed consent form must be signed by the subject or his legal guardian or caregiver. (6) If necessary, the subject can be accompanied by a nursing staff. (7) Before any assessment, the subject or his legal representative understands and signs a written informed consent. (8) Female subjects must have medical records to prove that they have passed surgical sterilization (such as hysterectomy, bilateral ovarian resection, or fallopian tube ligation) or have been menopausal for more than one year; if they are still able to conceive, they must be isolated during this research phase Contraception. (9) Male subjects must take isolation contraceptive measures during this research phase. Male subjects are not allowed to donate sperm during this study. (10) 18F-FDG and 11C-CFT PET, ultrasound examination (TCS), multi-sequence MRI examination, and clinical evaluation were performed in Huashan Hospital within 2 years. (11) Willing and able to cooperate with all projects of this research. Inclusion criteria for non-disease controls: (1) Age between 45 and 80 years old; gender is not limited. (2)

Exclusion criteria

Exclusion criteria: Exclusion criteria: Subjects who meet any of the following criteria will be excluded from the study: All subjects: (1) Suffer from serious other neurological diseases, or gastrointestinal, cardiovascular, liver, kidney, blood system, tumor, endocrine, respiratory system, immune deficiency and other serious diseases. (2) Metal devices that are not compatible with MRI have been implanted, including cardiac pacemakers, intravascular metal devices, insulin pumps, cochlear implants, nerve stimulators, cerebral aneurysm clips, etc. (3) Cannot tolerate MRI noise or suffer from occlusion phobia. (4) In the past year, due to other clinical medical or scientific research needs, have received ionizing radiation outside the scope of this test, so that the annual radiation exposure dose exceeds 50 mSv. (5) History of drug abuse or alcohol abuse. (6) Women during pregnancy or breastfeeding. (7) The venous condition is poor and cannot tolerate repeated venipuncture. (8) Have received treatment with experimental drugs or devices (with unclear efficacy or safety) within 1 month. (9) May be allergic to the components of 18F-FDG and/or 11C-CFT injection. (10) There is any situation that the research leader believes that any link related to this experiment may cause harm or have potential harm.

Design outcomes

Primary

MeasureTime frame
SUVR;Cortical volume;Cortical thickness;Energy entropy;Gray Level Co-occurrence Matrix;Graph theory features;Node degree;Node centrality;Global efficiency;Local efficiency;

Countries

China

Contacts

Public ContactChuantao Zuo

PET Center, Huashan Hospital, Fudan University

zuochuantao2000@126.com+86 13817933755

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026