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

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

• 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.