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

Not Applicable

Recruiting

• Conditions: Parkinson's Disease
• Interventions: Device: Directional deep brain stimualtion

• Registration Number: NCT05992701
• Lead Sponsor: Beijing Pins Medical Co., Ltd

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.

Study Timeline

• Study Start: 2021-07-28
• Study First Submitted: 2023-08-01
• Study First Submitted QC: 2023-08-14
• Study First Posted: 2023-08-15
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-14
• Last Update Posted: 2023-09-18
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 28

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Directional deep brain stimulation	Directional deep brain stimualtion	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Quality of Life	3 months post device-activation	Change in Parkinson's Disease Questionnaire (PDQ-39) summary score.
The dosage of anti-parkinsonian medications	3 months post device-activation
Adverse events	3 months post device-activation
Total Electrical Energy Delivered(TEED)	3 months post device-activation	TEED=(Voltage\^2×frequency×pulse width)/impedance×1 s

Trial Locations

Locations (9)

West China Hospital of Sichuan University; 🇨🇳 Chengdu, China

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, China

Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University; 🇨🇳 Beijing, China

Changhai Hospital, the Second Military Medical University; 🇨🇳 Shanghai, China

First Affiliated Hospital of Kunming Medical University; 🇨🇳 Kunming, China

Tianjin Medical University General Hospital; 🇨🇳 Tianjin, China

Shenzhen Second People's Hospital (the First Affiliated Hospital of Shenzhen University); 🇨🇳 Shenzhen, China

Zhongnan Hospital of Wuhan University; 🇨🇳 Wuhan, China

Nanjing Brain Hospital Affiliated to Nanjing Medical University; 🇨🇳 Nanjing, China