Advanced primary Parkinson's disease (PD)
Conditions
Interventions
Experimental group:Start up 20 days after surgery (±14 days)
Control group:Control group startup at 90 days after operation
Sponsors
Xuanwu Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with course of disease >= 4 years, in line with the clinical diagnosis of essential PD and surgical indications confirmed; patients with PD mainly tremor, after standard drug treatment of tremor improvement is not ideal and severe tremor, affecting the quality of life of patients, after evaluation relaxed to 3 years [according to the Chinese Parkinson's Disease Deep Brain Stimulation Therapy Expert Consensus (2nd Edition); 2. Aged 18-75 years; 3. Hoehn-Yahr stage 2.5-4; 4. Levodopa pulse test MDS UPDRS (Movement Disorder Society Unified Parkinson's Disease Rating Scale) III score improvement rate >= 30% (PD patients mainly tremor, after standard drug treatment of tremor improvement is not ideal and severe tremor, affecting the quality of life of patients, improvement rate can be < 30%); 5. Patients with basically normal cognitive function (MMSE determination is not cognitive impairment); 6. Subjects or their families can fully understand the therapy, have reasonable postoperative expectations, good compliance, can cooperate to complete postoperative follow-up requirements, Able to correctly fill in the subject PD diary; 7. Voluntarily participate in this trial and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Previous DBS implantation, or PD surgical treatment other than DBS, such as stereotactic lesioning, cell transplantation, gamma knife, etc. 2. Patients with contraindications to neurosurgery, as well as severe cardiovascular and cerebrovascular diseases. 3. Active implants in the body, such as cardiac pacemaker, defibrillator, drug infusion pump, cochlear implant, other neurostimulators (whether turned on or not); or passive implants affecting the stimulator system. 4. Hamilton Depression Rating Scale score (HAMD) > 24. 5. History of suicide or positive responders to items 2–5 of suicidal ideation in the Columbia Suicide Severity Rating Scale (C-SSRS). 6. Expected survival < 1 year. 7. Severe abnormal liver and kidney function and other systemic diseases that seriously affect health. 8. Patients who have participated in other clinical trials within three months. 9. Women who are pregnant or have the intention to become pregnant in the past year, lactating women. 10. Subjects with poor compliance as judged by the investigator, or who are not suitable for participating in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change value of MDS UPDRS III motor function score during the shutdown period from the baseline shutdown period verified that the test group; | — |
Secondary
| Measure | Time frame |
|---|---|
| The difference in the change of MDS UPDRS III motor function score between the control group and the baseline MDS UPDRS III motor function score;The change of MDS UPDRS III motor function score and the change of MDS UPDRS III motor function score at baseline;Change in MDS UPDRS II motor of daily living score;Change of MDS UPDRS IV complication score;Change of levodopa equivalent dose;39-item Parkinson's Quality of Life Questionnaire (PDQ39) score;Evaluation of Schwab and England Disability Scale;Investigator's evaluation on the service performance of device;Evaluation on the service performance of device by subjects; | — |
Countries
China
Contacts
Public ContactZhang Yuqing
Xuanwu Hospital, Capital Medical University
Outcome results
None listed