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

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

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.

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.

Inclusion Criteria:

1. Age at the time of enrollment: 18 ~ 75;
2. Idiopathic Parkinson's disease;
3. Patient whose symptoms are not adequately controlled by best medical therapy;
4. Hoehn and Yahr stage≥2.5;
5. Patient whose symptoms are improved by at least 30% with levodopa challenge test;
6. Must be an appropriate candidate for the surgical procedures required for bilateral DBS;
7. Is willing and able to comply with all visits and study related procedures;
8. 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:

1. Had received lesioning surgical treatment;
2. A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception;
3. Any current drug or alcohol abuse;
4. Cognitive impairment (MMSE≦17 for primary school education or MMSE≦24 for middle school education and above);
5. Any significant psychiatric problems, including unrelated clinically significant depression;
6. Any history of craniocerebral injury, tumor, or severe cerebrovascular disease;
7. Severe brain atrophy (confirmed by CT or MRI);
8. A condition requiring or likely to require the use of diathermy;
9. Abnormal blood routine or biochemical test, coagulation dysfunction, serious abnormal liver or kidney function;
10. Uncontrolled high blood pressure, serious heart disease or serious medical or respiratory diseases;
11. Long-term of immunosuppressive or hormone therapy;
12. Other diseases requiring the stimulators;
13. A condition requiring or likely to require the use of MRI;
14. Participated in any other clinical trials within the preceding 3 months;
15. Unwilling or unable to cooperate with the implantation of DBS system;
16. Unwilling or unable to cooperate with postoperative follow-up;
17. Not considered to be applicable by the investigator.