NCT05992701CompletedNot Applicable
Effectiveness and Safety of Directional Deep Brain Stimulation for Parkinson's Disease
Beijing Pins Medical Co., Ltd15 sites in 1 country26 target enrollmentStarted: July 28, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 26
- Locations
- 15
- Primary Endpoint
- Therapeutic Window
Study Overview
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.
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 collected: therapeutic window, Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores, Parkinson's Disease Questionnaire (PDQ-39) summary scores, total electrical energy delivered, the dosage of anti-parkinsonian medications, on time(h/d) without troublesome dyskinesia, and adverse events.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 Criteria
- •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.
Outcomes
Primary Outcomes
Therapeutic Window
Time Frame: 1 month post the device implanted
Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects.
Secondary Outcomes
- Motor Function(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)
- Adverse events(3 months post device-activation)
- Motor Function(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)
- Adverse events(3 months post device-activation)
- Change in PDQ-39 score(3 months post device-activation)
- On time(h/d) without troublesome dyskinesia(3 months post device-activation)
Investigators
Study Sites (15)
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