Parkinson Disease(PD)SMART-DBSNCT07635823
Adaptive DBS for PD
A study testing adaptive deep brain stimulation and conventional deep brain stimulation in people with Parkinson Disease(PD), run by Beijing Pins Medical Co., Ltd at 9 sites in China.
Trial summary
The goal of this clinical trial is to evaluate the efficacy and safety of an adaptive deep brain stimulation (aDBS) system for managing Parkinson's disease symptoms. Researchers will compare closed-loop stimulation (which automatically adjusts therapy using real-time brain signals and sleep monitoring) against… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease(PD)
- What is being tested?
- adaptive deep brain stimulation and conventional deep brain stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 9 sitesChina
- Study dates
- 16 May 2026to 30 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- idiopathic Parkinson's disease
- Hoehn \& Yahr (HY) stage 2.5-4 during medication "OFF"
- Subjects must meet one of the following:
- Never underwent DBS surgery and suitable for bilateral STN or GPi DBS surgery;
- Previous bilateral STN/GPi DBS recipients with only one IPG who:
- Demonstrate responsiveness to conventional cDBS therapy per investigator evaluation,
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- Consent to device replacement with G1010R DBS system.
- Willing and physically/mentally able to complete all study visits and procedures
- Capable of comprehending and providing written informed consent
Who cannot join
- Presence of contraindications to deep brain stimulation (DBS) surgery.
- Beck Depression Inventory-II (BDI-II) score > 25
- Mini-Mental State Examination (MMSE) score < 24 (adjusted for educational level)
- Significant comorbidities that may interfere with DBS therapy per investigator assessment.
- Pre-existing active non-DBS medical implants or metallic cranial implants
- Requirement for diathermy, transcranial magnetic stimulation (TMS), or electroconvulsive therapy (ECT) during the study period
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- History of ablative neurosurgery or stem cell therapy for Parkinson's disease
- Inability to complete ≥3 consecutive days of comprehensive motor/sleep diaries
- Inability to maintain prescribed medication regimens or comply with protocol requirements
- Current pregnancy, lactation, or planned pregnancy during the study period
- Other conditions deemed by investigators to compromise study suitability
- Participation in other interventional clinical trials within 4 weeks prior to consent
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites, 9 recruiting
- Recruiting
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 10000
Hutao Xie, +86 18756921517
Jianguo Zhang
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, Beijing Municipality, 10000
Kailiang Wang, +86 13521539544
Guoguang Zhao
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality
Yi Guo
- Recruiting
Xiangya Hospital of Central South University
Changsha, Hunan
Zhiquan Yang
- Not yet recruiting
West China Hospital
Chengdu, Sichuan
Wei Wang
- Not yet recruiting
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong
Jinsheng Zeng
Ling Chen
- Not yet recruiting
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Hefei, Anhui
Chaoshi Niu
- Not yet recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Weiguo Li
- Recruiting
Nanjing Brain Hospital
Nanjing, Jiangsu
Chang Qiu
Wenbin Zhang
About this study
Official title: Adaptive vs Conventional Deep Brain Stimulation for Parkinson's Disease: A Multi-center Randomized Controlled Trial
The goal of this clinical trial is to evaluate the efficacy and safety of an adaptive deep brain stimulation (aDBS) system for managing Parkinson's disease symptoms. Researchers will compare closed-loop stimulation (which automatically adjusts therapy using real-time brain signals and sleep monitoring) against traditional continuous stimulation (fixed settings) in a randomized, double-blind, crossover study. Participants will undergo surgical implantation of PINS Medical's G1010R neurostimulator, followed by alternating treatment phases where each patient experiences both aDBS and conventional open-loop stimulation modes. Outcomes will assess improvements in without troublesome dyskinesia daily time, motor symptoms (e.g., tremors, rigidity), quality of life, and sleep quality across both therapy periods.
Read the detailed description
The goal of this clinical trial is to evaluate the efficacy and safety of PINS Medical's rechargeable implantable closed-loop deep brain stimulation (aDBS) system for improving quality of life in Parkinson's disease patients. Researchers will compare adaptive closed-loop stimulation (which automatically adjusts therapy using real-time brain signals) against conventional open-loop stimulation (cDBS) in a prospective, multicenter, double-blind, randomized crossover study. Participants will undergo surgical implantation of the neurostimulator system and progress through five trial phases: screening/surgery, cDBS optimization, aDBS optimization, crossover evaluation, and long-term follow-up across nine visits. During crossover testing, each participant will experience both stimulation modes sequentially while blinded. Key outcomes include duration of troublesome/non-troublesome dyskinesia, "off" time, sleep scales (VAS, PDSS-2, PSQI), motor symptoms (MDS-UPDRS), quality of life (PDQ-39, EQ-5D-5L), and safety parameters. The primary analysis will occur after all randomized subjects complete crossover testing and unblinding (Visit 7).
- Conditions
- Parkinson Disease(PD)
- Being tested
- adaptive deep brain stimulation, conventional deep brain stimulation
- Keywords
- Parkinson Disease, Deep brain stimulation, Adaptive DBS, Close-loop DBS, Dyskinesia
- Medical subject headings
- Parkinson Disease, Dyskinesias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adaptive deep brain stimulationDevice
Also called closed-loop deep brain stimulation, aDBS, adaptive DBS
adaptive deep brain stimulation (aDBS) is a stimulation mode that measuring local field potential (LFP) signal nearby the electrodes of lead in the deep brain and decoding the signal in real-time, automatically adjusts amplitude of stimulation controlled by algorithm embedded in DBS device. aDBS is able to recognize patient status and allocate proper stimulation parameters based on need to treat Parkinson symptoms.
conventional deep brain stimulationDevice
Also called cDBS, traditional deep brain stimulation, conventional DBS, open-loop DBS
conventional deep brain stimulation is a common stimulation mode that has been used for years. It uses fixed stimulation parameters to treat Parkinson's disease and has been proved effective to motor symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Participants in this group will first take conventional DBS treatment for 30-45 days, then change to adaptive DBS treatment for another 30-45 days. Receives: Device: adaptive deep brain stimulation; Device: conventional deep brain stimulation |
| Group B | Experimental | Participants in this group will first take adaptive DBS treatment for 30-45 days, then change to conventional DBS treatment for another 30-45 days. Receives: Device: adaptive deep brain stimulation; Device: conventional deep brain stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold
In the Motor-Sleep Diary, in 30-minute intervals, patients recorded whether they were in the "On" condition (with dyskinesia, with non-troublesome dyskinesia, with troublesome dyskinesia), "Off" condition, or asleep. The "On" time without troublesome dyskinesia combined the categories of "On" time without dyskinesia and "On" time with non-troublesome dyskinesia. The Motor-Sleep Diary was collected at both the cDBS treatment and aDBS treatment during the crossover evaluation phases. The threshold was determined using the hours of "On" time without troublesome dyskinesia for aDBS is no worse than 2 hours per day less than cDBS. The proportion of aDBS subjects exceeding the threshold was the primary endpoint.
Measured: about one month each after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2026
- Study start16 May 2026
- Primary completion31 May 2027 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson Disease(PD)Studies 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
- Randomised
- Intervention model
- Crossover
- Model description
- This is a multi-center, blinded, crossover, randomized controlled study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Pins Medical Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital, Xuanwu Hospital, Beijing, Nanjing Brain Hospital, Qilu Hospital of Shandong University, West China Hospital, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial), Peking Union Medical College Hospital, Xiangya Hospital of Central South University, First Affiliated Hospital, Sun Yat-Sen University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07635823
- Sponsor's protocol ID
- G1010R&PINS-C2-01-53
- Acronym
- SMART-DBS
- Status last verified
- Jun 2026
- First submitted
- 3 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive vs Conventional Deep Brain Stimulation for Parkinson's Disease: A Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07635823
- Acronym / sponsor ID
- SMART-DBS / G1010R&PINS-C2-01-53
- Conditions
- Parkinson Disease(PD)
- Keywords
- Parkinson Disease, Deep brain stimulation, Adaptive DBS, Close-loop DBS, Dyskinesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beijing Pins Medical Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital, Xuanwu Hospital, Beijing, Nanjing Brain Hospital, Qilu Hospital of Shandong University, West China Hospital, The First Affiliated Hospital of China University of Science and Technology (Anhui Provincial), Peking Union Medical College Hospital, Xiangya Hospital of Central South University, First Affiliated Hospital, Sun Yat-Sen University
- Study start
- 16 May 2026 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 9 Jun 2026 (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 goal of this clinical trial is to evaluate the efficacy and safety of an adaptive deep brain stimulation (aDBS) system for managing Parkinson's disease symptoms. Researchers will compare closed-loop stimulation (which automatically adjusts therapy using real-time brain signals and sleep monitoring) against traditional continuous stimulation (fixed settings) in a randomized, double-blind, crossover study. Participants will undergo surgical implantation of PINS Medical's G1010R neurostimulator, followed by alternating treatment phases where each patient experiences both aDBS and conventional open-loop stimulation modes. Outcomes will assess improvements in without troublesome dyskinesia daily time, motor symptoms (e.g., tremors, rigidity), quality of life, and sleep quality across both therapy periods.
Detailed description
The goal of this clinical trial is to evaluate the efficacy and safety of PINS Medical's rechargeable implantable closed-loop deep brain stimulation (aDBS) system for improving quality of life in Parkinson's disease patients. Researchers will compare adaptive closed-loop stimulation (which automatically adjusts therapy using real-time brain signals) against conventional open-loop stimulation (cDBS) in a prospective, multicenter, double-blind, randomized crossover study. Participants will undergo surgical implantation of the neurostimulator system and progress through five trial phases: screening/surgery, cDBS optimization, aDBS optimization, crossover evaluation, and long-term follow-up across nine visits. During crossover testing, each participant will experience both stimulation modes sequentially while blinded. Key outcomes include duration of troublesome/non-troublesome dyskinesia, "off" time, sleep scales (VAS, PDSS-2, PSQI), motor symptoms (MDS-UPDRS), quality of life (PDQ-39, EQ-5D-5L), and safety parameters. The primary analysis will occur after all randomized subjects complete crossover testing and unblinding (Visit 7).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a multi-center, blinded, crossover, randomized controlled study.
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: adaptive deep brain stimulation, Device: conventional deep brain stimulationParticipants in this group will first take conventional DBS treatment for 30-45 days, then change to adaptive DBS treatment for another 30-45 days. |
| Group B | Experimental | Device: adaptive deep brain stimulation, Device: conventional deep brain stimulationParticipants in this group will first take adaptive DBS treatment for 30-45 days, then change to conventional DBS treatment for another 30-45 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- idiopathic Parkinson's disease
- Hoehn \& Yahr (HY) stage 2.5-4 during medication "OFF"
- Subjects must meet one of the following:
- Demonstrate responsiveness to conventional cDBS therapy per investigator evaluation,
- Consent to device replacement with G1010R DBS system.
Key exclusion criteria (12 listed)
- Presence of contraindications to deep brain stimulation (DBS) surgery.
- Beck Depression Inventory-II (BDI-II) score > 25
- Mini-Mental State Examination (MMSE) score < 24 (adjusted for educational level)
- Significant comorbidities that may interfere with DBS therapy per investigator assessment.
- Pre-existing active non-DBS medical implants or metallic cranial implants
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 |
|---|---|---|
| adaptive deep brain stimulationAlso: closed-loop deep brain stimulation, aDBS, adaptive DBSadaptive deep brain stimulation (aDBS) is a stimulation mode that measuring local field potential (LFP) signal nearby the electrodes of lead in the deep brain and decoding the signal in real-time, automatically adjusts amplitude of stimulation controlled by algorithm embedded in DBS device. aDBS is able to recognize patient status and allocate proper stimulation parameters based on need to treat Parkinson symptoms. | Device | Group A, Group B |
| conventional deep brain stimulationAlso: cDBS, traditional deep brain stimulation, conventional DBS, open-loop DBSconventional deep brain stimulation is a common stimulation mode that has been used for years. It uses fixed stimulation parameters to treat Parkinson's disease and has been proved effective to motor symptoms. | Device | Group A, Group B |
Primary outcome
Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold
Time frame: about one month each after randomization
In the Motor-Sleep Diary, in 30-minute intervals, patients recorded whether they were in the "On" condition (with dyskinesia, with non-troublesome dyskinesia, with troublesome dyskinesia), "Off" condition, or asleep. The "On" time without troublesome dyskinesia combined the categories of "On" time without dyskinesia and "On" time with non-troublesome dyskinesia. The Motor-Sleep Diary was collected at both the cDBS treatment and aDBS treatment during the crossover evaluation phases. The threshold was determined using the hours of "On" time without troublesome dyskinesia for aDBS is no worse than 2 hours per day less than cDBS. The proportion of aDBS subjects exceeding the threshold was the primary endpoint.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- 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.
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adaptive deep brain stimulation and conventional deep brain stimulation in people with Parkinson Disease(PD), 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 9 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jianguang Sun (+86 010-60736388, sunjianguang@pinsmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold (time frame: about one month each after randomization). 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 22 Jun 2026.