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

NCT ID: NCT05992701

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-28
• Study Completion Date: 2023-12-23

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.

Conditions

Parkinson's Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Directional deep brain stimulation

Group Type: EXPERIMENTAL

Directional deep brain stimualtion

Intervention Type: DEVICE

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.).

Interventions

Directional 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.).

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Tiantan Hospital

OTHER

Sponsor Role: collaborator

Changhai Hospital, the Second Military Medical University

UNKNOWN

Sponsor Role: collaborator

Shenzhen Second People's Hospital

OTHER

Sponsor Role: collaborator

Zhongnan Hospital

OTHER

Sponsor Role: collaborator

West China Hospital

OTHER

Sponsor Role: collaborator

Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University

UNKNOWN

Sponsor Role: collaborator

First Affiliated Hospital of Kunming Medical University

OTHER

Sponsor Role: collaborator

Nanjing Medical University

OTHER

Sponsor Role: collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role: collaborator

Beijing Pins Medical Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing Tiantan Hospital, Capital Medical University

Beijing, , China

Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University

Beijing, , China

West China Hospital of Sichuan University

Chengdu, , China

First Affiliated Hospital of Kunming Medical University

Kunming, , China

Nanjing Brain Hospital Affiliated to Nanjing Medical University

Nanjing, , China

Changhai Hospital, the Second Military Medical University

Shanghai, , China

Shenzhen Second People's Hospital (the First Affiliated Hospital of Shenzhen University)

Shenzhen, , China

Tianjin Medical University General Hospital

Tianjin, , China

Zhongnan Hospital of Wuhan University

Wuhan, , China

Countries

China

Other Identifiers

PINS-DBS-2101

Identifier Type: -

Identifier Source: org_study_id