Esta página foi traduzida automaticamente e a precisão da tradução não é garantida. Por favor, consulte o versão em inglês para um texto fonte.

Adaptive DBS for PD (SMART-DBS)

17 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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).

Tipo de estudo

Intervencional

Inscrição (Estimado)

60

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Estude backup de contato

Locais de estudo

  • China
    • Anhui
      • Hefei, Anhui, China
        • Ainda não está recrutando
        • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
        • Investigador principal:
          • Chaoshi Niu
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • Ainda não está recrutando
        • Peking Union Medical College Hospital
        • Investigador principal:
          • Yi Guo
      • Beijing, Beijing Municipality, China, 10000
        • Recrutamento
        • Beijing Tiantan Hospital, Capital Medical University
        • Investigador principal:
          • Jianguo Zhang
        • Contato:
          • Hutao Xie
          • Número de telefone: +86 18756921517
      • Beijing, Beijing Municipality, China, 10000
        • Recrutamento
        • Xuanwu Hospital, Capital Medical University
        • Contato:
          • Kailiang Wang
          • Número de telefone: +86 13521539544
        • Investigador principal:
          • Guoguang Zhao
    • Guangdong
      • Guangzhou, Guangdong, China
        • Ainda não está recrutando
        • First Affiliated Hospital, Sun Yat-Sen University
        • Investigador principal:
          • Jinsheng Zeng
        • Subinvestigador:
          • Ling Chen
    • Hunan
      • Changsha, Hunan, China
        • Recrutamento
        • Xiangya Hospital of Central South University
        • Investigador principal:
          • Zhiquan Yang
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Recrutamento
        • Nanjing Brain Hospital
        • Contato:
          • Chang Qiu
        • Investigador principal:
          • Wenbin Zhang
    • Shandong
      • Jinan, Shandong, China
        • Ainda não está recrutando
        • Qilu Hospital of Shandong University
        • Investigador principal:
          • Weiguo Li
    • Sichuan
      • Chengdu, Sichuan, China
        • Ainda não está recrutando
        • West China Hospital
        • Investigador principal:
          • Wei Wang

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição cruzada
  • Mascaramento: Quadruplicar

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Dispositivo: 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.
Outros nomes:
  • aDBS
  • DBS adaptativo
  • closed-loop deep brain stimulation
Dispositivo: 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.
Outros nomes:
  • cDBS
  • traditional deep brain stimulation
  • conventional DBS
  • open-loop DBS
Experimental: 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.
Dispositivo: 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.
Outros nomes:
  • aDBS
  • DBS adaptativo
  • closed-loop deep brain stimulation
Dispositivo: 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.
Outros nomes:
  • cDBS
  • traditional deep brain stimulation
  • conventional DBS
  • open-loop DBS

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Motor-sleep dairy
Prazo: 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
Recharging DBS Experience
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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:

  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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Beijing Pins Medical Co., Ltd

Colaboradores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

16 de maio de 2026

Conclusão Primária (Estimado)

31 de maio de 2027

Conclusão do estudo (Estimado)

30 de setembro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

3 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

3 de junho de 2026

Primeira postagem (Real)

9 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

22 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • G1010R&PINS-C2-01-53

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

Se inscrever