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

December 3, 2025 updated by: Beijing Pins Medical Co., Ltd
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Therapeutic Window
Time Frame: 1 month post the device implanted
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
On time(h/d) without troublesome dyskinesia
Time Frame: 3 months post device-activation
3 months post device-activation
Adverse events
Time Frame: 3 months post device-activation
3 months post device-activation
Motor Function
Time Frame: 3 months post device-activation
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)
Time Frame: 3 months post device-activation
TEED=(Voltage^2×frequency×pulse width)/impedance×1 s
3 months post device-activation
The dosage of anti-parkinsonian medications
Time Frame: 3 months post device-activation
3 months post device-activation
Change in PDQ-39 score
Time Frame: 3 months post device-activation
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Pins Medical Co., Ltd

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 28, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 13, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 23, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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