Effectiveness and Safety of Directional Deep Brain Stimulation for Parkinson's Disease

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness and Safety of Directional Deep Brain Stimulation for Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Device: Directional deep brain stimualtion


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Directional deep brain stimulation<br> | Device: Directional deep brain stimualtion<br>* 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.).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Function | Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III score. | 3 months post device-activation | 
| Quality of Life | Change in Parkinson's Disease Questionnaire (PDQ-39) summary score. | 3 months post device-activation | 
| Total Electrical Energy Delivered(TEED) | TEED=(Voltage^2×frequency×pulse width)/impedance×1 s | 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 |