Parkinson’s Disease
Conditions
Interventions
Prospective GBA-GPi-DBS Group:None
Retrospective GBA-STN-DBS group:None
Retrospective GBA-nonDBS group:None
Retrospective GU-STN-DBS group:None
Retrospective GBA- GPi -DBS group:None
Sponsors
Ethics Review Committee of Huashan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Prospective GBA-GPi-DBS group inclusion criteria: Those who meet all of the following conditions can be included in the study: (1) Age between 40 and 80 years old, gender not limited. (2) There are clinical symptoms of Parkinson's movement disorder, and the diagnosis is independently evaluated and confirmed by two relevant specialist physicians from the Neurology Department of Huashan Hospital. In case of any diagnostic disagreement, the movement disorder Specialist Group of the neurology Department will discuss and decide. If necessary, further diagnosis confirmation or adjustment will be made. (3) Genetic testing has been completed, and the carrier of GBA1 heterozygous mutation has been verified by long-read PCR. (4) After assessment by a neurologist specializing in movement disorders, the patient is not inclined to choose the STN target but meets the indications for bilateral GPI-targeted DBS surgery. (5) If one is currently receiving drug treatment for improving symptoms of neurodegenerative movement disorders, a stable dose must be maintained for at least 30 days before the start of the study. (6) Before any assessment commences, the research participant himself/herself or his/her legal representative has understood and signed a written informed consent form. (7) Female participants must meet any of the following conditions: (a) Have a medical record proving that they have been sterilized (such as hysterectomy, bilateral oophorectomy or tubal ligation); (b) Natural menopause =1 year; (c) If fertile, pregnancy and lactation must be excluded, and a commitment must be made to take effective contraceptive measures during the study period and within three months after the study ends. (8) Male participants must take effective contraceptive measures during the study period and within three months after the study ends, and are not allowed to donate sperm. (9) Be willing and capable of completing all the processes and evaluations of this research. Note: If there are special difficulties during the research participation process (such as mobility issues, language communication barriers, etc.), the accompanying personnel (such as guardians or notarized witnesses) may assist in completing the relevant assessment. Whether to accompany or not is determined by actual needs. Not all subjects need to be accompanied. 2. Inclusion criteria for the retrospective GBA-STN-DBS group: (1) Age between 40 and 80 years old, gender not limited. (2) There are clinical symptoms of Parkinson's movement disorder, and the diagnosis is independently evaluated and confirmed by two relevant specialist physicians from the Neurology Department of Huashan Hospital. (3) Genetic testing has been completed, and the carrier of GBA1 heterozygous mutation has been verified by long-read PCR. (4) Bilateral STN-DBS surgery has been completed, and there are complete clinical assessment materials and [¹8F]-FDG PET/CT imaging data both at the preoperative baseline and one year after the surgery. (5) The research participant himself/herself or his/her legal representative has signed a written informed consent form for the sample bank. 3. Inclusion criteria for the retrospective GB-NONDBS group: (1) Age, gender, and educational attainment were matched with those of the subjects in the GB-STN-DBS group. (2) There are clinical symptoms of Parkinson's movement disorder, and the diagnosis is independently evaluated and confirmed by two relevant specialist physicians from the Neurology
Exclusion criteria
Exclusion criteria: The exclusion criteria for the prospective GP-GPI-DBS group: Those who meet any of the following conditions will be excluded: (1) Those who are evaluated as not meeting the conditions for GPi-DBS surgery. (2) Diagnosed with Parkinson's superimposed syndrome or other secondary Parkinson's diseases. (3) Combined with serious other neurological diseases, or severe gastrointestinal, cardiovascular, liver, kidney, blood system, tumor, endocrine, respiratory system, immune deficiency and other major systemic diseases. (4) Carrying other known pathogenic mutations or high-risk gene variations for Parkinson's disease. (5) Having received ionizing radiation outside the scope of this study within the past year, with an annual cumulative dose exceeding 50 mSv. (6) Has a history of drug abuse or alcoholism. (7) Pregnant or lactating women. (8) Poor venous conditions, unable to tolerate repeated venipuncture. (9) Having received experimental drug or device treatment whose efficacy and safety have not been verified within one month. (10) The researcher believes that participating in this study may pose risks or potential hazards to them. (11) Have contraindications for PET examination or are unwilling to undergo PET examination. Exclusion criteria for the retrospective GBA-STN-DBS group: (1) Parkinson's disease superimposed syndrome. (2) Other secondary Parkinson's diseases. (3) Those with concurrent diseases of the central or peripheral nervous system. (4) Those with other serious internal medicine system diseases that they cannot tolerate the assessment. (5) Carrying other known pathogenic mutations and variations at risk sites. (6) Where the preoperative baseline data and postoperative clinical assessment data or imaging data in the sample bank are incomplete. 3. Exclusion criteria for the retrospective GBA-nonDBS group (1) Parkinson's disease superimposed syndrome. (2) Other secondary Parkinson's diseases. (3) Those with concurrent diseases of the central or peripheral nervous system. (4) Those with other serious internal medicine system diseases that they cannot tolerate the assessment. (5) Carrying other known pathogenic mutations and variations at risk sites. (6) Those with incomplete baseline and 1-year later clinical assessment data or imaging data in the sample bank. 4. Exclusion criteria for the retrospective GU-STN-DBS group: (1) Parkinson's disease superimposed syndrome. (2) Other secondary Parkinson's diseases. (3) Those with concurrent diseases of the central or peripheral nervous system. (4) Those with other serious internal medicine system diseases that they cannot tolerate the assessment. (5) Carrying other known pathogenic mutations and variations at risk sites. (6) Where the preoperative baseline data and postoperative clinical assessment data or imaging data in the sample bank are incomplete. 5. Exclusion criteria for the retrospective GPA-GPI-DBS group (1) Parkinson's disease superimposed syndrome. (2) Other secondary Parkinson's diseases. (3) Those with concurrent diseases of the central or peripheral nervous system. (4) Those with other serious internal medicine system diseases that they cannot tolerate the assessment. (5) Carrying other known pathogenic mutations and variations at risk sites. (6) Where the preoperative baseline data and postoperative clinical assessment data or imaging data in the sample bank are incomplete.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Standardized uptake value ratio; | — |
Secondary
| Measure | Time frame |
|---|---|
| Score of the Mini-Mental State Examination;MDS- Unified Parkinson's Disease Rating Scale III score;Montreal Cognitive Assessment Scale score;Parkinson's Disease Non-motor Symptom Scale score;Parkinson's Disease Quality of Life Scale score; | — |
Countries
China
Contacts
Public ContactYimin Sun
Huashan Hospital Affiliated to Fudan University
Outcome results
None listed