Status:
COMPLETED
Effectiveness and Safety of Directional Deep Brain Stimulation for Parkinson's Disease
Lead Sponsor:
Beijing Pins Medical Co., Ltd
Collaborating Sponsors:
Beijing Tiantan Hospital
Changhai Hospital, the Second Military Medical University
Conditions:
Parkinson's Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The purpose of this study is to demonstrate the safety and effectiveness of the PINS Deep Brain Stimulation (DBS) system, including the G107R/G107 IPG, L305/L306 directional leads, E204 extensions and...
Detailed Description
This is a prospective, open label, non-randomized study. The study will evaluate the clinical outcome and possible adverse effects of the directional DBS treatment. The following data will be collecte...
Eligibility Criteria
Inclusion
- Age at the time of enrollment: 18 \~ 75;
- Idiopathic Parkinson's disease;
- Patient whose symptoms are not adequately controlled by best medical therapy;
- Hoehn and Yahr stage≥2.5;
- Patient whose symptoms are improved by at least 30% with levodopa challenge test;
- Must be an appropriate candidate for the surgical procedures required for bilateral DBS;
- Is willing and able to comply with all visits and study related procedures;
- Patient understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
Exclusion
- Had received lesioning surgical treatment;
- A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception;
- Any current drug or alcohol abuse;
- Cognitive impairment (MMSE≦17 for primary school education or MMSE≦24 for middle school education and above);
- Any significant psychiatric problems, including unrelated clinically significant depression;
- Any history of craniocerebral injury, tumor, or severe cerebrovascular disease;
- Severe brain atrophy (confirmed by CT or MRI);
- A condition requiring or likely to require the use of diathermy;
- Abnormal blood routine or biochemical test, coagulation dysfunction, serious abnormal liver or kidney function;
- Uncontrolled high blood pressure, serious heart disease or serious medical or respiratory diseases;
- Long-term of immunosuppressive or hormone therapy;
- Other diseases requiring the stimulators;
- A condition requiring or likely to require the use of MRI;
- Participated in any other clinical trials within the preceding 3 months;
- Unwilling or unable to cooperate with the implantation of DBS system;
- Unwilling or unable to cooperate with postoperative follow-up;
- Not considered to be applicable by the investigator.
Key Trial Info
Start Date :
July 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 23 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT05992701
Start Date
July 28 2021
End Date
December 23 2023
Last Update
December 10 2025
Active Locations (9)
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1
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
2
Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University
Beijing, China
3
West China Hospital of Sichuan University
Chengdu, China
4
First Affiliated Hospital of Kunming Medical University
Kunming, China