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Adaptive DBS for PD RCT (SMART-DBS)

3. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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).

Studientyp

Interventionell

Einschreibung (Geschätzt)

60

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Crossover-Aufgabe
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
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.
Gerät: 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.
Andere Namen:
  • aDBS
  • adaptives DBS
  • closed-loop deep brain stimulation
Gerät: 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.
Andere Namen:
  • 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.
Gerät: 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.
Andere Namen:
  • aDBS
  • adaptives DBS
  • closed-loop deep brain stimulation
Gerät: 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.
Andere Namen:
  • cDBS
  • traditional deep brain stimulation
  • conventional DBS
  • open-loop DBS

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of aDBS Subjects With "On" Time Without Troublesome Dyskinesia Exceeding the Threshold
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Motor-sleep dairy
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Beijing Pins Medical Co., Ltd

Mitarbeiter

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

16. Mai 2026

Primärer Abschluss (Geschätzt)

31. Mai 2027

Studienabschluss (Geschätzt)

30. September 2027

Studienanmeldedaten

Zuerst eingereicht

3. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. Juni 2026

Zuerst gepostet (Tatsächlich)

9. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • G1010R&PINS-C2-01-53

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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