Clinical trial NCT06494956: To Evaluate the Safety of DBS in Patients With Primary Parkinson's Disease
Official title: A Prospective, Single-center, Open Clinical Study to Evaluate the Safety of Implantable Rechargeable Computerized Deep Nerve Stimulation Systems in Patients With Primary Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Parkinson Disease Dementia
Lead sponsor: Jiangsu CED Medtech Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-07-10
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To evaluate the safety of implantable rechargeable computer deep nerve stimulation system produced by Jiangsu Changyida Medical Technology Co., Ltd. for patients with primary Parkinson's disease

Detailed description: To evaluate the safety of implantable rechargeable computer deep nerve stimulation system produced by Jiangsu Changyida Medical Technology Co., Ltd. for patients with primary Parkinson's disease

Eligibility criteria: Inclusion Criteria:1. Aged 18-70 years old, patients with primary Parkinson's disease;2. The duration 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 motion score ≥30 in "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, and repeated adjustments 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 treatment and sign informed consent;10. The patient had good compliance and was able to meet the requirements of postoperative follow-up.

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. The "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. Have other concomitant diseases, have or need to implant a pacemaker, defibrillator, cochlear implant, other neurostimulator, or need to undergo frequent magnetic examinations;5. Patients who are abnormally sensitive to temperature or allergic to heat;6. There are concomitant diseases that seriously affect health, such as tumors, serious abnormalities of liver and kidney function (indicators exceeding three times the normal value).7. Patients with anxiety and depression.

Primary outcomes:
measure: Start time assessment: Calculate the start time (no change) per day based on the Parkinson's disease diary
timeFrame: 7 months
measure: Subjects fill in a diary card after device implantation
timeFrame: 6 months
measure: Drug dosage evaluation
timeFrame: 7 months
measure: Charging performance evaluation
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
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