Adaptive DBS for PD (SMART-DBS)
2026年6月17日 更新者：Beijing Pins Medical Co., Ltd
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.
研究概览
详细说明
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).
研究类型
介入性
注册 (估计的)
60
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Jianguang Sun
- 电话号码：+86 010-60736388
- 邮箱：sunjianguang@pinsmedical.com
研究联系人备份
- 姓名：Qihang Shi
- 电话号码：+86 18511837185
- 邮箱：shiqihang@pinsmedical.com
学习地点
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Anhui
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Hefei、Anhui、中国
- 尚未招聘
- The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
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首席研究员：
- Chaoshi Niu
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Beijing Municipality
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Beijing、Beijing Municipality、中国
- 尚未招聘
- Peking Union Medical College Hospital
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首席研究员：
- Yi Guo
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Beijing、Beijing Municipality、中国、10000
- 招聘中
- Beijing Tiantan Hospital, Capital Medical University
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首席研究员：
- Jianguo Zhang
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接触：
- Hutao Xie
- 电话号码：+86 18756921517
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Beijing、Beijing Municipality、中国、10000
- 招聘中
- Xuanwu Hospital, Capital Medical University
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接触：
- Kailiang Wang
- 电话号码：+86 13521539544
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首席研究员：
- Guoguang Zhao
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Guangdong
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Guangzhou、Guangdong、中国
- 尚未招聘
- First Affiliated Hospital, Sun Yat-Sen University
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首席研究员：
- Jinsheng Zeng
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副研究员：
- Ling Chen
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Hunan
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Changsha、Hunan、中国
- 招聘中
- Xiangya Hospital of Central South University
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首席研究员：
- Zhiquan Yang
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Jiangsu
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Nanjing、Jiangsu、中国
- 招聘中
- Nanjing Brain Hospital
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接触：
- Chang Qiu
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首席研究员：
- Wenbin Zhang
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Shandong
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Jinan、Shandong、中国
- 尚未招聘
- Qilu Hospital of Shandong University
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首席研究员：
- Weiguo Li
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Sichuan
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Chengdu、Sichuan、中国
- 尚未招聘
- West China Hospital
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首席研究员：
- Wei Wang
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- 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,
- 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
Exclusion Criteria:
- 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
- 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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Group A
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.
|
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.
其他名称：
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.
其他名称：
|
|
实验性的：Group B
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.
|
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.
其他名称：
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.
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold
大体时间：about one month each after randomization
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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.
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about one month each after randomization
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Motor-sleep dairy
大体时间：about one month 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 Motor-sleep Diary also collects a visual analogue scale that subjects use to evaluate overall quality of sleep last night. 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 the cDBS treatment and aDBS treatment during crossover evaluation phases. Motor-sleep Diary collects 5 measurements:
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about one month after randomization
|
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Recharging DBS Experience
大体时间：about one month after randomization
|
Recharging DBS Experience measures the experience of subject recharge DBS device under each treatment.
It is evaluated by recharging interval and accumulation of electric energy depletion.
The numeric results are calculated using DBS recharging dairy embedded in the device.
The more frequently recharge or the more electric energy is depleted, the poor experience the subjects have.
The measurements will be collected for each treatment during crossover phase and will be compared.
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about one month after randomization
|
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TEED
大体时间：about one month after randomization
|
Total Electric Energy Delivered(TEED) measures the amount of energy consumed by stimulation for each treatment.
The numeric result are estimated by DBS stimulation parameters.
The measurements will be collected for each treatment during crossover phase and will be compared.
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about one month after randomization
|
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Peripheral Device Measurements
大体时间：about one month after randomization
|
Peripheral device measurements include motor and sleep metrics that can offer extra symptom analysis.
The measurements will be collected for each treatment during crossover phase and will be compared.
|
about one month after randomization
|
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GIC
大体时间：about 14 days after programming during adjustment phase
|
The Global Impression Change Score(GIC) measure the acceptance of each treatment after programming compared to the previous treatment.
It is evaluated by subject using effectiveness and side effect to acquire a status code that can be analyzed descriptively.
The measurements will be collected for each treatment during adjustment phase and will be compared.
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about 14 days after programming during adjustment phase
|
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MDS UPDRS
大体时间：about one month after randomization
|
The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) contains 4 parts. Each parts range as the following: 0~52, 0~52, 0~132, 0~24. Lower score means better rating on the according symptoms. Each measures different perspective of motor disorder. In this trial, 5 measurements will be collected:
The result of each treatment will be compared. |
about one month after randomization
|
|
PDSS-2
大体时间：about one month after randomization
|
Parkinson's Disease Sleep Scale 2(PDSS-2) measures the quality of sleep of Parkinson's Disease.
The scale ranges from 0 to 60. Lower score means better rating on sleep conditions.
Measurement will be collected at cDBS treatment and aDBS treatment during crossover phases.
The result of each treatment will be compared.
|
about one month after randomization
|
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PSQI
大体时间：about one month after randomization
|
Pittsburgh sleep quality index(PSQI) measures the quality of sleep.
The scale ranges from 0 to 21. Lower score means better rating on the quality of sleep.
Measurement will be collected at cDBS treatment and aDBS treatment during crossover phases.
The result of each treatment will be compared.
|
about one month after randomization
|
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PDQ-39
大体时间：about 6 months after randomization
|
Parkinson's Disease Questionnaire-39(PDQ-39) measures the quality of life of Parkinson's Disease, containing 39 items that range from 0 to 4. The final score is computed through the following steps: 1. calculate the average score of every item in 8 dimensions and span the results to a range from 0 to 100; 2. calculate the average score of all dimensions.
The final score ranges from 0 to 100.
Lower score means better rating on the quality of life.
Measurement will be collected at cDBS treatment and aDBS treatment during crossover phases and 2 follow-up visits after crossover.
The result of each treatment will be compared.
Overall result will be analyzed descriptively.
|
about 6 months after randomization
|
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EQ-5D-5L
大体时间：about 6 months after randomization
|
EQ-5D-5L measures the quality of life, containing 5 questions and 1 visual analogue scale(VAS) for rating of subjective conclusive quality of life.
The results of 5 questions form a state code of 5 digits.
The state code will be transformed to EQ-5D index score using a values set for China.
Measurements will be collected at cDBS treatment and aDBS treatment during crossover phases and 2 follow-up visits after crossover.
The results of each treatment will be compared.
Overall result will be analyzed descriptively.
|
about 6 months after randomization
|
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Patient Preference Questionnaire
大体时间：about 2 months after randomization
|
Patient Preference Questionnaire measures the preference to each treatments while blinded.
The questionnaire contains 6 independent questions.
Each option of every question will be counted as a percentage.
Measurement will be collected at the end of last crossover phase before unblinding.
The result of each treatment will be compared and analyzed descriptively.
|
about 2 months after randomization
|
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Patient Satisfaction Questionnaire
大体时间：about 6 months after randomization
|
Patient Satisfaction Questionnaire measures the satisfaction with each treatments.
The questionnaire contains 3 independent questions.
Each option of every question will be counted as a percentage.
Measurement will be collected at the end of entire trial before completion.
The result of each treatment will be compared and analyzed descriptively.
|
about 6 months after randomization
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年5月16日
初级完成 (估计的)
2027年5月31日
研究完成 (估计的)
2027年9月30日
研究注册日期
首次提交
2026年6月3日
首先提交符合 QC 标准的
2026年6月3日
首次发布 (实际的)
2026年6月9日
研究记录更新
最后更新发布 (实际的)
2026年6月22日
上次提交的符合 QC 标准的更新
2026年6月17日
最后验证
2026年6月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.