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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Device: Directional deep brain stimualtion

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 Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China
    • Beijing Tiantan Hospital, Capital Medical University
  • Beijing, China
    • Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University
  • Chengdu, China
    • West China Hospital of Sichuan University
  • Kunming, China
    • First Affiliated Hospital of Kunming Medical University
  • Nanjing, China
    • Nanjing Brain Hospital Affiliated to Nanjing Medical University
  • Shanghai, China
    • ChangHai Hospital, The Second Military Medical University
  • Shenzhen, China
    • Shenzhen Second People's Hospital (the First Affiliated Hospital of Shenzhen University)
  • Tianjin, China
    • Tianjin Medical University General Hospital
  • Wuhan, China
    • Zhongnan Hospital Of Wuhan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Directional deep brain stimulation	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.).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
On time(h/d) without troublesome dyskinesia		3 months post device-activation
Adverse events		3 months post device-activation
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
Total Electrical Energy Delivered(TEED)	TEED=(Voltage^2×frequency×pulse width)/impedance×1 s	3 months post device-activation
The dosage of anti-parkinsonian medications		3 months post device-activation
Change in PDQ-39 score	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.	3 months post device-activation

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 28, 2021
• Primary Completion (Actual): November 13, 2023
• Study Completion (Actual): December 23, 2023

Study Registration Dates

• First Submitted: August 1, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 15, 2023

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: PINS-DBS-2101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No