Parkinson's disease
Conditions
Interventions
Control group:Stimulator implantation without start-up and electrical stimulation treatment
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with primary PD meet the Diagnostic Criteria for Parkinson's Disease in China published in 2016, or meet the diagnostic criteria for primary PD issued by the International Society for Parkinson's Disease and Movement Disorders (MDS) in 2015, aged 18-75 years; 2. PD patients with disease course >=5 years. If the disease course is less than 5 years, but meets the criteria for clinical diagnosis of primary PD, the surgical indication is clear, and the disease course can be relaxed to 4 years. For PD patients mainly with tremor, the improvement of tremor was not ideal and the tremor was serious after standard drug treatment, which affected the quality of life of the patients. After evaluation, it was relaxed to 3 years; 3. Hoehn-Yahr stages of the close period ranged from 2.5 to 4 stages; 4. Exercise score of Unified Parkinson's Disease Rating Scale (UPDRS) >=30 and improvement rate of acute levodopa stress test >=30%; 5. Patients with basically normal cognitive function; 6. Patients or their family members can fully understand the therapy, have reasonable postoperative expectations, have good compliance, can cooperate to complete the postoperative follow-up requirements, and can correctly fill in the PD diary of subjects; 7. Participate in this experiment voluntarily and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. Have received DBS implantation or surgical treatment for PD other than DBS, such as stereotactic mutilation, cell transplantation, gamma knife, etc. 2. There are contraindications of neurosurgery and serious cardiovascular and cerebrovascular diseases. 3. Active implants such as cardiac pacemakers, defibrillators, cochlear implants, drug infusion pumps, other nerve stimulators, etc. (whether opened or not); Or have passive implants that affect the DBS system. 4. According to DSM-IV standards, score of Baker Depression Scale (BDI-II) >=17. 5. Suicidal ideation occurs in people with a history of suicide or in items 2-5 of the ‘’suicidal ideation’’ subscale of the Columbia Suicide Severity Rating Scale (C-SSRS). 6. According to the DSM-IV diagnostic criteria, there are drug or alcohol abusers. 7. Patients with advanced malignant tumor and life expectancy < 1 year. 8. Complicated with serious abnormal liver and kidney function and other systemic diseases that seriously affect health. 9. Patients who have participated in other clinical trials within 30 days. 10. Lactating and pregnant patients and those who have recently planned to give birth. 11. Patients s considered unsuitable for this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change value of UPDRS motor score during off-period from baseline ;Experimental group: Change value of UPDRS movement score during off-period from baseline;Control group: UPDRS exercise scores in off-phase condition compared with 12 weeks after randomization; | — |
Secondary
| Measure | Time frame |
|---|---|
| UPDRS motor score;UPDRS activities of daily living score;Levodopa equivalent dose;The on-period of subject awakening;Parkinson's Disease Questionnaire - 39;Schwab and England Activities of Daily Living Score;Overall evaluation of clinical efficacy(Global Impression of Change Scale);Evaluation of the usage performance of the medical devices; | — |
Countries
China
Contacts
Public ContactYu Yanbing
China-Japan Friendship Hospital
Outcome results
None listed