Parkinson's disease
Conditions
Interventions
Test Group:the DBS system was kept on from1 to 3 months after the surgery
Control Group:the system was kept off for 3 months after the surgery
Sponsors
Fourth Military Medical 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 |
|---|---|
| the change in the motor function scores (UPDRS-Ill) in subjects of both the test group and control group upon withdrawal of medications at the end of 3 months after the surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| change in daily living scores (UPDRS-II) in subjects of both test group and control group under medications at the end of 3, 6 and 12 months after the surgery;change in mental, behavioral and emotional situation scores (UPDRS-I) in subjects of both test group and control group upon under medications at the end of 3,6 and 12 months after the surgery;changes in complication scores (UPDRS-IV) in the subjects of both test and control group under medications at the end of 3, 6, and 12 months after the surgery;changes in 'on' period and “off” recorded in the diaries of subjects in both test and control groups at the end of 3,6, and 12 months after the surgery;changes in motor function scores (UPDRS-III) during the 'on' and 'off' period of the stimulation in subjects of the test group upon withdrawal of medications('off') at the end of 3 months after the surgery;changes in motor function scores (UPDRS-III) during the 'on' and 'off' period of the stimulation in subjects of the test group under medications and upon withdrawal of medications('off') at the end of 12 months after the surgery;evaluation of the surgery;satisfaction of the subjects; | — |
Countries
China
Contacts
Public ContactGuodong Gao
Department of Neurosurgery, Tangdu Hospital, Fourth Military Medical University
Outcome results
None listed