Primary Parkinson's disease
Conditions
Interventions
Experimental group:Implant implantable rechargeable computer deep nerve stimulation system device
Sponsors
Sanbo Brain Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Aged 18-70 years, patients with primary Parkinson's disease; 2) The course of Parkinson's disease is 5 years or more; 3) The stage of Hoehn-Yahr in the "off" (without medication) state is 2 or more stages; 4) UPDRS exercise score =30 in the "Off" state; 5) Good response to dopamine drugs, acute levodopa experiment UPDRS exercise score improvement rate of more than 30% (experimental drug Medoba 250mg); 6) The daily drug shutdown period is at least 6 hours, or there are sports complications such as serious transactions, repeated adjustment of drugs still cannot be effectively improved; 7) MMSE score =24 points on the simple intelligent mental State Examination Scale; 8) Have the ability of independent external charging operation; 9) Patients or their family members can fully understand the therapy and sign informed consent; 10) The patient had good compliance and was able to meet the requirements of postoperative follow-up.
Exclusion criteria
Exclusion criteria: 1) Have received surgical treatment for Parkinson's disease other than deep brain stimulation, such as stereotactic destruction, cell transplantation, gamma knife, etc.; 2) "Off" state has serious language disorders, dysphagia, balance disorders and other midline symptoms; 3) There are contraindications for neurosurgery, such as cerebral infarction, hydrocephalus, cerebral atrophy, ventricle enlargement, cerebrovascular sequelae, heart disease, severe thrombocytopenia and other cardiovascular and cerebrovascular diseases; 4) There are other concomitant diseases, have or need to implant a pacemaker, defibrillator, cochlear implant, other nerve stimulator, or need to undergo frequent magnetic examinations; 5) Patients who are abnormally sensitive to temperature or allergic to heat; 6) There are tumors, liver and kidney function serious abnormalities (indicators more than three times the normal value) and other serious health associated diseases. 7) Patients with anxiety and depression.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Start time assessment: Calculate the start time (no change) per day according to the Parkinson's disease diary.;UPDRS scores were assessed for subjects taking/not taking medication on/off before/after stimulator implantation:;Drug dosage assessment: the types of anti-Parkinson's drugs used by subjects were standardized before surgery, and the types and dosages of drugs were changed after surgery under the guidance of experienced clinicians.;Charging performance evaluation: Through the stimulator charging frequency, charging time, etc., to evaluate the effectiveness of the pulse generator charging.; | — |
Countries
China
Contacts
Public ContactGuoming Luan
Sanbo Brain Hospital, Capital Medical University
Outcome results
None listed