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

Parkinson's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05992701
• Other study ID #: PINS-DBS-2101
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: Beijing Pins Medical Co., Ltd
• Contact: Jianguang Sun
• Phone: 010-60736388
• Email: sunjianguang[@]pinsmedical.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 28
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Device:
• 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.).

Locations

Country	Name	City	State
China	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

Sponsors (10)

Lead Sponsor	Collaborator
Beijing Pins Medical Co., Ltd	Beijing Tiantan Hospital, Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University, Changhai Hospital, the Second Military Medical University, First Affiliated Hospital of Kunming Medical University, Nanjing Medical University, Shenzhen Second People's Hospital, Tianjin Medical University General Hospital, West China Hospital, Wuhan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Therapeutic Window	Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects.	1 month post the device implanted
Secondary	Motor Function	Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III score.	3 months post device-activation
Secondary	Quality of Life	Change in Parkinson's Disease Questionnaire (PDQ-39) summary score.	3 months post device-activation
Secondary	Total Electrical Energy Delivered(TEED)	TEED=(Voltage^2×frequency×pulse width)/impedance×1 s	3 months post device-activation
Secondary	The dosage of anti-parkinsonian medications		3 months post device-activation
Secondary	On time(h/d) without troublesome dyskinesia		3 months post device-activation
Secondary	Adverse events		3 months post device-activation