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Adaptive DBS for PD (SMART-DBS)

17 de junio de 2026 actualizado 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

Intervencionista

Inscripción (Estimado)

60

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Porcelana
    • Anhui
      • Hefei, Anhui, Porcelana
        • Aún no reclutando
        • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
        • Investigador principal:
          • Chaoshi Niu
    • Beijing Municipality
      • Beijing, Beijing Municipality, Porcelana
        • Aún no reclutando
        • Peking Union Medical College Hospital
        • Investigador principal:
          • Yi Guo
      • Beijing, Beijing Municipality, Porcelana, 10000
        • Reclutamiento
        • Beijing Tiantan Hospital, Capital Medical University
        • Investigador principal:
          • Jianguo Zhang
        • Contacto:
          • Hutao Xie
          • Número de teléfono: +86 18756921517
      • Beijing, Beijing Municipality, Porcelana, 10000
        • Reclutamiento
        • Xuanwu Hospital, Capital Medical University
        • Contacto:
          • Kailiang Wang
          • Número de teléfono: +86 13521539544
        • Investigador principal:
          • Guoguang Zhao
    • Guangdong
      • Guangzhou, Guangdong, Porcelana
        • Aún no reclutando
        • First Affiliated Hospital, Sun Yat-Sen University
        • Investigador principal:
          • Jinsheng Zeng
        • Sub-Investigador:
          • Ling Chen
    • Hunan
      • Changsha, Hunan, Porcelana
        • Reclutamiento
        • Xiangya Hospital of Central South University
        • Investigador principal:
          • Zhiquan Yang
    • Jiangsu
      • Nanjing, Jiangsu, Porcelana
        • Reclutamiento
        • Nanjing Brain Hospital
        • Contacto:
          • Chang Qiu
        • Investigador principal:
          • Wenbin Zhang
    • Shandong
      • Jinan, Shandong, Porcelana
        • Aún no reclutando
        • Qilu Hospital of Shandong University
        • Investigador principal:
          • Weiguo Li
    • Sichuan
      • Chengdu, Sichuan, Porcelana
        • Aún no reclutando
        • West China Hospital
        • Investigador principal:
          • Wei Wang

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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.
Otros nombres:
  • ADBS
  • DBS adaptativa
  • 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.
Otros nombres:
  • 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.
Otros nombres:
  • ADBS
  • DBS adaptativa
  • 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.
Otros nombres:
  • cDBS
  • traditional deep brain stimulation
  • conventional DBS
  • open-loop DBS

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Motor-sleep dairy
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

16 de mayo de 2026

Finalización primaria (Estimado)

31 de mayo de 2027

Finalización del estudio (Estimado)

30 de septiembre de 2027

Fechas de registro del estudio

Enviado por primera vez

3 de junio de 2026

Primero enviado que cumplió con los criterios de control de calidad

3 de junio de 2026

Publicado por primera vez (Actual)

9 de junio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de junio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

17 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • G1010R&PINS-C2-01-53

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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