Effectiveness and Safety of Directional Deep Brain Stimulation for Parkinson's Disease
1 other identifier
interventional
26
1 country
9
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 related system components.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2021
Typical duration for not_applicable
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 28, 2021
CompletedFirst Submitted
Initial submission to the registry
August 1, 2023
CompletedFirst Posted
Study publicly available on registry
August 15, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 13, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 23, 2023
CompletedDecember 10, 2025
December 1, 2025
2.3 years
August 1, 2023
December 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Therapeutic Window
Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects.
1 month post the device implanted
Secondary Outcomes (6)
Motor Function
3 months post device-activation
Change in PDQ-39 score
3 months post device-activation
Total Electrical Energy Delivered(TEED)
3 months post device-activation
The dosage of anti-parkinsonian medications
3 months post device-activation
On time(h/d) without troublesome dyskinesia
3 months post device-activation
- +1 more secondary outcomes
Study Arms (1)
Directional deep brain stimulation
EXPERIMENTALInterventions
Directional deep brain stimualtion in the treatment of Parkinson's disease using L305/L306 leads and G107R/G107 implanted pulse generators (Beijing Pins Medical Co.).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Pins Medical Co., Ltdlead
- Beijing Tiantan Hospitalcollaborator
- Changhai Hospital, the Second Military Medical Universitycollaborator
- Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua Universitycollaborator
- First Affiliated Hospital of Kunming Medical Universitycollaborator
- Nanjing Medical Universitycollaborator
- Tianjin Medical University General Hospitalcollaborator
- Shenzhen Second People's Hospitalcollaborator
- Zhongnan Hospitalcollaborator
- West China Hospitalcollaborator
Study Sites (9)
Beijing Tiantan Hospital, Capital Medical University
Beijing, China
Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University
Beijing, China
West China Hospital of Sichuan University
Chengdu, China
First Affiliated Hospital of Kunming Medical University
Kunming, China
Nanjing Brain Hospital Affiliated to Nanjing Medical University
Nanjing, China
Changhai Hospital, the Second Military Medical University
Shanghai, China
Shenzhen Second People's Hospital (the First Affiliated Hospital of Shenzhen University)
Shenzhen, China
Tianjin Medical University General Hospital
Tianjin, China
Zhongnan Hospital of Wuhan University
Wuhan, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2023
First Posted
August 15, 2023
Study Start
July 28, 2021
Primary Completion
November 13, 2023
Study Completion
December 23, 2023
Last Updated
December 10, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will not share