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Adaptive DBS for PD RCT (SMART-DBS)

3 czerwca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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).

Typ studiów

Interwencyjne

Zapisy (Szacowany)

60

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Chiny
    • Anhui
      • Hefei, Anhui, Chiny
        • Jeszcze nie rekrutacja
        • The First Affiliated Hospital of USTC (Anhui Provincial Hospital)
        • Główny śledczy:
          • Chaoshi Niu
    • Beijing Municipality
      • Beijing, Beijing Municipality, Chiny
        • Jeszcze nie rekrutacja
        • Peking Union Medical College Hospital
        • Główny śledczy:
          • Yi Guo
      • Beijing, Beijing Municipality, Chiny, 10000
        • Rekrutacyjny
        • Beijing Tiantan Hospital, Capital Medical University
        • Główny śledczy:
          • Jianguo Zhang
        • Kontakt:
          • Hutao Xie
          • Numer telefonu: +86 18756921517
      • Beijing, Beijing Municipality, Chiny, 10000
        • Rekrutacyjny
        • Xuanwu Hospital, Capital Medical University
        • Kontakt:
          • Kailiang Wang
          • Numer telefonu: +86 13521539544
        • Główny śledczy:
          • Guoguang Zhao
    • Guangdong
      • Guangzhou, Guangdong, Chiny
        • Jeszcze nie rekrutacja
        • First Affiliated Hospital, Sun Yat-Sen University
        • Główny śledczy:
          • Jinsheng Zeng
        • Pod-śledczy:
          • Ling Chen
    • Hunan
      • Changsha, Hunan, Chiny
        • Rekrutacyjny
        • Xiangya Hospital of Central South University
        • Główny śledczy:
          • Zhiquan Yang
    • Jiangsu
      • Nanjing, Jiangsu, Chiny
        • Rekrutacyjny
        • Nanjing Brain Hospital
        • Kontakt:
          • Chang Qiu
        • Główny śledczy:
          • Wenbin Zhang
    • Shandong
      • Jinan, Shandong, Chiny
        • Jeszcze nie rekrutacja
        • Qilu Hospital of Shandong University
        • Główny śledczy:
          • Weiguo Li
    • Sichuan
      • Chengdu, Sichuan, Chiny
        • Jeszcze nie rekrutacja
        • West China Hospital
        • Główny śledczy:
          • Wei Wang

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie
  • Przydział: Randomizowane
  • Model interwencyjny: Zadanie krzyżowe
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: 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.
Urządzenie: 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.
Inne nazwy:
  • ADBS
  • adaptacyjna DBS
  • closed-loop deep brain stimulation
Urządzenie: 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.
Inne nazwy:
  • cDBS
  • traditional deep brain stimulation
  • conventional DBS
  • open-loop DBS
Eksperymentalny: 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.
Urządzenie: 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.
Inne nazwy:
  • ADBS
  • adaptacyjna DBS
  • closed-loop deep brain stimulation
Urządzenie: 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.
Inne nazwy:
  • cDBS
  • traditional deep brain stimulation
  • conventional DBS
  • open-loop DBS

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold
Ramy czasowe: 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

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Motor-sleep dairy
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Beijing Pins Medical Co., Ltd

Współpracownicy

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

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

16 maja 2026

Zakończenie podstawowe (Szacowany)

31 maja 2027

Ukończenie studiów (Szacowany)

30 września 2027

Daty rejestracji na studia

Pierwszy przesłany

3 czerwca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

3 czerwca 2026

Pierwszy wysłany (Rzeczywisty)

9 czerwca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

9 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

3 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • G1010R&PINS-C2-01-53

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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