Parkinson's Disease
Conditions
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.
Interventions
DEVICEDirectional deep brain stimualtion
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.).
Sponsors
Beijing Tiantan Hospital
Changhai Hospital, the Second Military Medical University
Shenzhen Second People's Hospital
Zhongnan Hospital
West China Hospital
Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University
First Affiliated Hospital of Kunming Medical University
Nanjing Medical University
Tianjin Medical University General Hospital
Beijing Pins Medical Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Therapeutic Window | 1 month post the device implanted | Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in PDQ-39 score | 3 months post device-activation | Using the Parkinson's Disease Questionnaire to acquire a score ranging from 0 to 156 as a summary of all subscores from 39 items. The higher score indicates lower quality of life. |
| Total Electrical Energy Delivered(TEED) | 3 months post device-activation | TEED=(Voltage\^2×frequency×pulse width)/impedance×1 s |
| Motor Function | 3 months post device-activation | Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III score. |
| On time(h/d) without troublesome dyskinesia | 3 months post device-activation | — |
| Adverse events | 3 months post device-activation | — |
| The dosage of anti-parkinsonian medications | 3 months post device-activation | — |
Countries
China
Outcome results
None listed