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.
調査の概要
状態
募集
条件
詳細な説明
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).
研究の種類
介入
入学 (推定)
60
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Jianguang Sun
- 電話番号：+86 010-60736388
- メール：sunjianguang@pinsmedical.com
研究連絡先のバックアップ
- 名前：Qihang Shi
- 電話番号：+86 18511837185
- メール：shiqihang@pinsmedical.com
研究場所
-
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Anhui
-
Hefei、Anhui、中国
- まだ募集していません
- The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
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主任研究者：
- Chaoshi Niu
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Beijing Municipality
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Beijing、Beijing Municipality、中国
- まだ募集していません
- Peking Union Medical College Hospital
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主任研究者：
- Yi Guo
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Beijing、Beijing Municipality、中国、10000
- 募集
- Beijing Tiantan Hospital, Capital Medical University
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主任研究者：
- Jianguo Zhang
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コンタクト：
- Hutao Xie
- 電話番号：+86 18756921517
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Beijing、Beijing Municipality、中国、10000
- 募集
- Xuanwu Hospital, Capital Medical University
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コンタクト：
- Kailiang Wang
- 電話番号：+86 13521539544
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主任研究者：
- Guoguang Zhao
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Guangdong
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Guangzhou、Guangdong、中国
- まだ募集していません
- First Affiliated Hospital, Sun Yat-Sen University
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主任研究者：
- Jinsheng Zeng
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副調査官：
- Ling Chen
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Hunan
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Changsha、Hunan、中国
- 募集
- Xiangya Hospital of Central South University
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主任研究者：
- Zhiquan Yang
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Jiangsu
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Nanjing、Jiangsu、中国
- 募集
- Nanjing Brain Hospital
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コンタクト：
- Chang Qiu
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主任研究者：
- Wenbin Zhang
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Shandong
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Jinan、Shandong、中国
- まだ募集していません
- Qilu Hospital of Shandong University
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主任研究者：
- Weiguo Li
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Sichuan
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Chengdu、Sichuan、中国
- まだ募集していません
- West China Hospital
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主任研究者：
- Wei Wang
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
他の名前：
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.
他の名前：
|
|
実験的：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.
他の名前：
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.
他の名前：
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold
時間枠：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.
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about one month each after randomization
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Motor-sleep dairy
時間枠：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:
|
about one month after randomization
|
|
Recharging DBS Experience
時間枠：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.
|
about one month after randomization
|
|
TEED
時間枠：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.
|
about one month after randomization
|
|
Peripheral Device Measurements
時間枠：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
|
|
GIC
時間枠：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.
|
about 14 days after programming during adjustment phase
|
|
MDS UPDRS
時間枠：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
時間枠：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
|
|
PSQI
時間枠：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
|
|
PDQ-39
時間枠：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
|
|
EQ-5D-5L
時間枠：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
|
|
Patient Preference Questionnaire
時間枠：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
|
|
Patient Satisfaction Questionnaire
時間枠：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
|
協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
協力者
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年5月16日
一次修了 (推定)
2027年5月31日
研究の完了 (推定)
2027年9月30日
試験登録日
最初に提出
2026年6月3日
QC基準を満たした最初の提出物
2026年6月3日
最初の投稿 (実際)
2026年6月9日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月22日
QC基準を満たした最後の更新が送信されました
2026年6月17日
最終確認日
2026年6月1日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- G1010R&PINS-C2-01-53
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。