Clinical trial NCT05992701: Effectiveness and Safety of Directional Deep Brain Stimulation for Parkinson's Disease
Official title: Effectiveness and Safety of Directional Deep Brain Stimulation for Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson's Disease
Lead sponsor: Beijing Pins Medical Co., Ltd
Sponsor class: INDUSTRY
Collaborators: name: Beijing Tiantan Hospital
name: Changhai Hospital, the Second Military Medical University
name: Shenzhen Second People's Hospital
name: Wuhan University
name: West China Hospital
name: Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University
name: First Affiliated Hospital of Kunming Medical University
name: Nanjing Medical University
name: Tianjin Medical University General Hospital
First posted: 2023-08-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Therapeutic Window
timeFrame: 1 month post the device implanted
Secondary outcomes:
measure: Motor Function
timeFrame: 3 months post device-activation
measure: Quality of Life
timeFrame: 3 months post device-activation
measure: Total Electrical Energy Delivered(TEED)
timeFrame: 3 months post device-activation
measure: The dosage of anti-parkinsonian medications
timeFrame: 3 months post device-activation
measure: On time(h/d) without troublesome dyskinesia
timeFrame: 3 months post device-activation
measure: Adverse events
timeFrame: 3 months post device-activation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
city: Beijing
country: China
facility: Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University
city: Chengdu
country: China
facility: West China Hospital of Sichuan University
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
city: Nanjing
country: China
facility: Nanjing Brain Hospital Affiliated to Nanjing Medical University
city: Shanghai
country: China
facility: Changhai Hospital, the Second Military Medical University
city: Shenzhen
country: China
facility: Shenzhen Second People's Hospital (the First Affiliated Hospital of Shenzhen University)
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Wuhan
country: China
facility: Zhongnan Hospital of Wuhan University
Study officials:
References: