Status:
UNKNOWN
Study on the Efficacy and Safety of Rechargeable Implantable DBS System in the Treatment of Parkinson's Disease
Lead Sponsor:
Lepu Medical Technology (Beijing) Co., Ltd.
Conditions:
Parkinson Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this clinical trial is to verify the efficacy and safety of rechargeable implantable deep brain stimulation (DBS) system for the treatment of advanced primary Parkinson's disease.
Detailed Description
This study is a prospective, multicenter, randomized controlled superiority clinical study. According to the unified inclusion and exclusion criteria, 60 eligible subjects are enrolled in this clinica...
Eligibility Criteria
Inclusion
- 18-75 years old, male or female;.
- Primary PD (according to the UK Parkinson's Disease Society Brain Bank clinical diagnostic criteria for primary PD or Chinese diagnostic criteria for primary PD), with a duration of PD ≥ 4 years, and the improvement rate after an acute levodopa challenge test ≥ 30%; or primary PD, mainly characterized by tremor, the improvement of tremor by standardized drug treatment is not satisfactory and tremor is severe, which affects the patients' quality of life, after evaluation, duration can be relaxed to 3 years, the improvement rate of acute levodopa challenge test can be\<30%.
- The use of levodopa once had good effects, but currently cannot satisfactorily control symptoms (significant decrease in efficacy or occurrence of fluctuations in motor function or motor dysfunction), which affects quality of life.
- Good compliance, patients and their families have the willingness to participate in the clinical trial of "bilateral implantation surgery of nervous stimulation system", voluntarily participate in this trial and sign informed consent form, patients can follow up regularly, and can accurately complete of assessment items, or the family members, guardians, or caregivers may assist the patients.
Exclusion
- Severe cognitive impairment (MMSE score: illiterate\<17, elementary school\<20, junior high school or above\<24), poor compliance due to dementia, and/or inability to sign informed consent form
- Patients with a history of severe mental illness and a Hamilton Depression Scale (HAMD) score\>24
- Seizure history in the last 1 year
- Patients with severe heart, liver and kidney diseases, severe hypertension and severe orthostatic hypotension that affect their health status.
- Patients with severe diabetes or serious cardiovascular and cerebrovascular diseases that affect their health status
- Confirmed malignant tumor
- Patients with surgical contraindications (e.g., the presence of active implants (whether turned on or not), or the presence of non-active implants that may affect the deep brain stimulation system, stereotactic nucleus lesioning, etc.), or other surgical procedures within six months that the researchers believe have an impact on this trial, or other neurosurgery contraindications
- Patients who have suffered a previous cranial neurological injury
- Women who are pregnant or preparing for pregnancy
- Patients with severe alcohol dependence and drug abuse
- Patients who received electric shock therapy within 30 days before surgery
- Patients who are abnormally sensitive to temperature or who are allergic to heat
- Subjects who are currently participating in other clinical trials or have participated in other clinical studies that have not reached the primary endpoint within three months.
- Patients who are not suitable to participate in this clinical study in the opinion of the investigator.
Key Trial Info
Start Date :
July 20 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 20 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05997667
Start Date
July 20 2023
End Date
July 20 2025
Last Update
August 18 2023
Active Locations (7)
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1
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China, 100053
2
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350004
3
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510260
4
Renmin Hospital of Wuhan University
Wuhan, Hubei, China, 430060