Parkinson's disease
Conditions
Sponsors
Zhengzhou Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Prior to the surgery, patients and their families must have a thorough understanding of the surgical risks and postoperative management, provide informed consent for this trial, and voluntarily sign a written informed consent form. They should maintain effective communication with the investigators and comply with all clinical trial requirements (scheduled visits, laboratory tests, and other trial procedures), as well as be willing to participate in the 24-week follow-up of the trial. 2. No gender restrictions, age less than 75 years 3. Participants must have a disease duration of more than 5 years and meet the 2015 MDS diagnostic criteria for Parkinson’s disease or the 2016 Chinese diagnostic criteria for Parkinson’s disease, confirmed as having primary Parkinson’s disease, with Hoehn and Yahr (H-Y) stage between 2.5 and 4. 4. Subjects must have been on a stable dose of anti-Parkinson medication for at least 30 days prior to entering the study. 5. Other Parkinsonian syndromes (such as multiple system atrophy, progressive supranuclear palsy, cortical-basal syndrome, Lewy body dementia, drug-induced Parkinsonism, vascular Parkinsonism, etc.) are to be excluded.
Exclusion criteria
Exclusion criteria: 1. Participants with MMSE = 24, indicating dementia or severe psychiatric disorders. 2. Subjects with severe alcohol or drug dependence or a history of drug/alcohol abuse. 3. Pregnant or breastfeeding women. 4. Individuals who have undergone surgical procedures for Parkinson's disease, such as Deep Brain Stimulation, Lesioning or ablative surgeries. 5. Individuals with a clear history of neurological diseases (such as intracranial hemorrhage, multiple strokes or a stroke within the past 24 weeks, brain tumors, or hydrocephalus). 6. Patients with unstable cardiac conditions, severe renal disease requiring dialysis, or others who cannot tolerate surgery or anesthesia. 7. Presence of other surgical contraindications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in total UPDRS score at 12 weeks postoperatively relative to baseline ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in UPDRS (I) scores relative to baseline;Changes in UPDRS (?) scores relative to baseline;Changes in UPDRS (?) scores relative to baseline;Changes in PDQ-39 scores relative to baseline;Changes in NMSS scores relative to baseline;Changes in PDSS scores relative to baseline;Changes in the Clinical Global Impressions scale (CGI) ;Changes in HAMA Scale and HMAD Scale-17 scores relative to baseline;Changes in brain lymphatic system imaging indices relative to baseline;Changes in hematological inflammatory markers ; | — |
Countries
China
Contacts
Public ContactGaiqing Yang
Zhengzhou Central Hospital
Outcome results
None listed