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Adaptive DBS for PD RCT (SMART-DBS)

2026년 6월 3일 업데이트: 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.

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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).

연구 유형

중재적

등록 (추정된)

60

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 중국
    • Anhui
      • Hefei, Anhui, 중국
        • 아직 모집하지 않음
        • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
        • 수석 연구원:
          • Chaoshi Niu
    • Beijing Municipality
      • Beijing, Beijing Municipality, 중국
        • 아직 모집하지 않음
        • Peking Union Medical College Hospital
        • 수석 연구원:
          • Yi Guo
      • Beijing, Beijing Municipality, 중국, 10000
        • 모병
        • Beijing Tiantan Hospital, Capital Medical University
        • 수석 연구원:
          • Jianguo Zhang
        • 연락하다:
          • Hutao Xie
          • 전화번호: +86 18756921517
      • Beijing, Beijing Municipality, 중국, 10000
        • 모병
        • Xuanwu Hospital, Capital Medical University
        • 연락하다:
          • Kailiang Wang
          • 전화번호: +86 13521539544
        • 수석 연구원:
          • Guoguang Zhao
    • Guangdong
      • Guangzhou, Guangdong, 중국
        • 아직 모집하지 않음
        • First Affiliated Hospital, Sun Yat-Sen University
        • 수석 연구원:
          • Jinsheng Zeng
        • 부수사관:
          • Ling Chen
    • Hunan
      • Changsha, Hunan, 중국
        • 모병
        • Xiangya Hospital of Central South University
        • 수석 연구원:
          • Zhiquan Yang
    • Jiangsu
      • Nanjing, Jiangsu, 중국
        • 모병
        • Nanjing Brain Hospital
        • 연락하다:
          • Chang Qiu
        • 수석 연구원:
          • Wenbin Zhang
    • Shandong
      • Jinan, Shandong, 중국
        • 아직 모집하지 않음
        • Qilu Hospital of Shandong University
        • 수석 연구원:
          • Weiguo Li
    • Sichuan
      • Chengdu, Sichuan, 중국
        • 아직 모집하지 않음
        • West China Hospital
        • 수석 연구원:
          • Wei Wang

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

Inclusion Criteria:

  • idiopathic Parkinson's disease
  • Hoehn & Yahr (HY) stage 2.5-4 during medication "OFF"

  • Subjects must meet one of the following:

    1. Never underwent DBS surgery and suitable for bilateral STN or GPi DBS surgery;
    2. 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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 크로스오버 할당
  • 마스킹: 네 배로

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
장치: adaptive deep brain stimulation
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.
다른 이름들:
  • aDBS
  • 적응형 DBS
  • closed-loop deep brain stimulation
장치: conventional deep brain stimulation
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.
다른 이름들:
  • cDBS
  • traditional deep brain stimulation
  • conventional DBS
  • open-loop DBS
실험적: 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.
장치: adaptive deep brain stimulation
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.
다른 이름들:
  • aDBS
  • 적응형 DBS
  • closed-loop deep brain stimulation
장치: conventional deep brain stimulation
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.
다른 이름들:
  • cDBS
  • traditional deep brain stimulation
  • conventional DBS
  • open-loop DBS

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold
기간: 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.
about one month each after randomization

기타 결과 측정

결과 측정
측정값 설명
기간
Motor-sleep dairy
기간: 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:

  1. daily "On" time without troublesome dyskinesia
  2. daily "On" time with troublesome dyskinesia
  3. daily "Off" time
  4. daily asleep time
  5. quality of sleep The result of 2 type of treatments and baseline will be compared.
about one month after randomization
MDS UPDRS
기간: about one month after randomization

The Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS UPDRS) contains 4 parts. Each measures different perspective of motor disorder. In this trial, 5 measurements will be collected:

  1. MDS UPDRS part I
  2. MDS UPDRS part II ("best" condition)
  3. MDS UPDRS part II ("worst" condition)
  4. MDS UPDRS part III
  5. MDS UPDRS part IV Each measurements 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
PDSS-2
기간: about one month after randomization
Parkinson's Disease Sleep Scale 2(PDSS-2) measures the quality of sleep of Parkinson's Disease. 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
기간: about one month after randomization
Pittsburgh sleep quality index(PSQI) measures 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
기간: about 6 months after randomization
Parkinson's Disease Questionnaire-39(PDQ-39) measures the quality of life of Parkinson's Disease. 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
기간: about 6 months after randomization
EQ-5D-5L measures 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
Patient Preference Questionnaire
기간: about 2 months after randomization
Patient Preference Questionnaire measures the preference to each treatments while blinded. 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
기간: about 6 months after randomization
Patient Satisfaction Questionnaire measures the satisfaction with each treatments. 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
Recharging DBS Experience
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Beijing Pins Medical Co., Ltd

협력자

Xiangya Hospital of Central South University
Peking Union Medical College Hospital
Beijing Tiantan Hospital
First Affiliated Hospital, Sun Yat-Sen University
West China Hospital
Qilu Hospital of Shandong University
Xuanwu Hospital, Beijing
The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
Nanjing Brain Hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 5월 16일

기본 완료 (추정된)

2027년 5월 31일

연구 완료 (추정된)

2027년 9월 30일

연구 등록 날짜

최초 제출

2026년 6월 3일

QC 기준을 충족하는 최초 제출

2026년 6월 3일

처음 게시됨 (실제)

2026년 6월 9일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 6월 9일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 6월 3일

마지막으로 확인됨

2026년 6월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • G1010R&PINS-C2-01-53

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

파킨슨병(PD)에 대한 임상 시험

adaptive deep brain stimulation에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

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정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

구독하다