Parkinson's disease
Conditions
Interventions
Case series :STN DBS
Sponsors
Yuquan Hospital of Tsinghua University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years old male or female; 2. signed informed consent form; 3. primary Parkinsons disease based on the diagnostic criteria of the UK Parkinsons Disease Society Brain Bank for primary Parkinsons disease or the Chinese criteria for Parkinsons disease with a disease course of = 5 years; 4. the efficacy of levodopa has significantly decreased, and motor function fluctuates or motor dysfunction is presented, which reduces the quality of life; 5. adequate dosages of the optimal medications (i.e., levodopa) have been received; 6. Parkinsons disease severity is at Hoehn-Yahr Stage 2.5-4 when medications are not being taken; 7. good compliance, i.e., patients and their families are willing to be enrolled in the clinical trial for bilateral neurostimulation implantation, receive follow-up regularly, can accurately complete the subjects diary during wakefulness, and the family, custodian, or caretaker can help the subject; 8. improvement after L-dopa stimulation test is no less than 30%; 9. off period is more than 4 hours per day.
Exclusion criteria
Exclusion criteria: 1. patients with Parkinsonism and Parkinsonism-plus syndrome; 2. patients who have severe cognitive impairment (MMSE score: illiteracy <17, elementary school <20, junior high school or above <24) due to dementia, the compliance of the subject is poor, the subject cannot accurately record in a diary, and/or cannot sign the informed consent form; 3. patients who have a history of severe psychiatric disease; 4. patients who have a history of refractory epilepsy (i.e., epileptic seizures); 5. patients who have serious heart, liver, or kidney diseases, severe hypertension, and orthostatic hypotension; 6. patients who have severe diabetes or diabetes accompanied with brain and cardiovascular diseases; 7. patients diagnosed with cancer; 8. patients who have contraindications to surgery (such as cochlear implants, pacemakers, cardiac defibrillators, stereotactic nucleus ablation, or unilateral or bilateral implantation of similar products), patients who have been enrolled in a study within 6 months and have received other surgeries that could affect the trial, or patients with other contraindications to neurosurgery; 9. patients who have had brain injuries; 10. patients who are taking anticoagulants or have a tendency of bleeding; 11. women who are pregnant or planning to become pregnant; 12. patients with severe alcohol dependence and drug abuse; 13. patients who received electric shock treatment within 30 days before the neurostimulation surgery; 14. subjects who are participating in other clinical trials, or who participated in other clinical trials within a month; 15. patients who are deemed inappropriate for the clinical trial by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in parkinson's disease symptoms as determined by UPDRS scores during the study as compared with baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in PDQ-39;Change in medication usage during the study as compared with baseline; | — |
Countries
China
Contacts
Public ContactMa Yu
Yuquan Hospital of Tsinghua University
Outcome results
None listed