Parkinson's DiseaseNCT05992701
Effectiveness and Safety of Directional Deep Brain Stimulation for Parkinson's Disease
A study testing Directional deep brain stimualtion in people with Parkinson's Disease, run by Beijing Pins Medical Co., Ltd at 9 sites in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Directional deep brain stimualtion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 9 sitesChina
- Study dates
- 28 Jul 2021to 23 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age at the time of enrollment: 18 ~ 75;
- Idiopathic Parkinson's disease;
- Patient whose symptoms are not adequately controlled by best medical therapy;
- Hoehn and Yahr stage≥2.5;
- Patient whose symptoms are improved by at least 30% with levodopa challenge test;
- Must be an appropriate candidate for the surgical procedures required for bilateral DBS;
- Is willing and able to comply with all visits and study related procedures;
- Patient understands the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed.
Who cannot join
- Had received lesioning surgical treatment;
- A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception;
- Any current drug or alcohol abuse;
- Cognitive impairment (MMSE≦17 for primary school education or MMSE≦24 for middle school education and above);
- Any significant psychiatric problems, including unrelated clinically significant depression;
- Any history of craniocerebral injury, tumor, or severe cerebrovascular disease;
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- Severe brain atrophy (confirmed by CT or MRI);
- A condition requiring or likely to require the use of diathermy;
- Abnormal blood routine or biochemical test, coagulation dysfunction, serious abnormal liver or kidney function;
- Uncontrolled high blood pressure, serious heart disease or serious medical or respiratory diseases;
- Long-term of immunosuppressive or hormone therapy;
- Other diseases requiring the stimulators;
- A condition requiring or likely to require the use of MRI;
- Participated in any other clinical trials within the preceding 3 months;
- Unwilling or unable to cooperate with the implantation of DBS system;
- Unwilling or unable to cooperate with postoperative follow-up;
- Not considered to be applicable by the investigator.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
China9 sites
Beijing Tiantan Hospital, Capital Medical University
Beijing
Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University
Beijing
West China Hospital of Sichuan University
Chengdu
First Affiliated Hospital of Kunming Medical University
Kunming
Nanjing Brain Hospital Affiliated to Nanjing Medical University
Nanjing
Changhai Hospital, the Second Military Medical University
Shanghai
Shenzhen Second People's Hospital (the First Affiliated Hospital of Shenzhen University)
Shenzhen
Tianjin Medical University General Hospital
Tianjin
Zhongnan Hospital of Wuhan University
Wuhan
About this study
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.
Read the 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
- Being tested
- Directional deep brain stimualtion
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Directional deep brain stimualtionDevice
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.).
| Study group | Role | What they receive |
|---|---|---|
| Directional deep brain stimulation | Experimental | Not described Receives: Device: Directional deep brain stimualtion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic Window
Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects.
Measured: 1 month post the device implanted
Secondary outcomes (6)
Motor Function
Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III score.
Measured: 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.
Measured: 3 months post device-activation
Total Electrical Energy Delivered(TEED)
TEED=(Voltage^2×frequency×pulse width)/impedance×1 s
Measured: 3 months post device-activation
The dosage of anti-parkinsonian medications
Measured: 3 months post device-activation
On time(h/d) without troublesome dyskinesia
Measured: 3 months post device-activation
Adverse events
Measured: 3 months post device-activation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start28 Jul 2021
- Primary completion13 Nov 2023
- Study completion23 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital, Changhai Hospital, Shenzhen Second People's Hospital, Zhongnan Hospital, West China Hospital, Beijing Tsinghua Changgeng Hospital, First Affiliated Hospital of Kunming Medical University, Nanjing Medical University, Tianjin Medical University General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05992701
- Sponsor's protocol ID
- PINS-DBS-2101
- Status last verified
- Dec 2025
- First submitted
- 1 Aug 2023
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of Directional Deep Brain Stimulation for Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05992701
- Acronym / sponsor ID
- PINS-DBS-2101
- Conditions
- Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital, Changhai Hospital, Shenzhen Second People's Hospital, Zhongnan Hospital, West China Hospital, Beijing Tsinghua Changgeng Hospital, First Affiliated Hospital of Kunming Medical University, Nanjing Medical University, Tianjin Medical University General Hospital
- Study start
- 28 Jul 2021 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 23 Dec 2023 (actual)
- First posted
- 15 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Directional deep brain stimulation | Experimental | Device: Directional deep brain stimualtion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age at the time of enrollment: 18 ~ 75;
- Idiopathic Parkinson's disease;
- Patient whose symptoms are not adequately controlled by best medical therapy;
- Hoehn and Yahr stage≥2.5;
- Patient whose symptoms are improved by at least 30% with levodopa challenge test;
Key exclusion criteria (17 listed)
- Had received lesioning surgical treatment;
- A female who is breastfeeding or of child-bearing potential with a positive urine pregnancy test or not using adequate contraception;
- Any current drug or alcohol abuse;
- Cognitive impairment (MMSE≦17 for primary school education or MMSE≦24 for middle school education and above);
- Any significant psychiatric problems, including unrelated clinically significant depression;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Directional deep brain stimualtionDirectional deep brain stimualtion in the treatment of Parkinson's disease using L305/L306 leads and G107R/G107 implanted pulse generators (Beijing Pins Medical Co.). | Device | Directional deep brain stimulation |
Primary outcome
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.
6 secondary outcomes
Motor Function
Time frame: 3 months post device-activation
Change in PDQ-39 score
Time frame: 3 months post device-activation
Total Electrical Energy Delivered(TEED)
Time frame: 3 months post device-activation
The dosage of anti-parkinsonian medications
Time frame: 3 months post device-activation
On time(h/d) without troublesome dyskinesia
Time frame: 3 months post device-activation
Adverse events
Time frame: 3 months post device-activation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Directional deep brain stimualtion in people with Parkinson's Disease, run by Beijing Pins Medical Co., Ltd at 9 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Therapeutic Window (time frame: 1 month post the device implanted). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.