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Temporale Interferenzstimulation bei motorischen Symptomen der Parkinson-Krankheit

28. Mai 2026 aktualisiert von: Yu Liu, Shanghai University of Sport

Wirkungen und Mechanismen der nicht-invasiven tiefen Hirnstimulation bei Patienten mit Parkinson-Krankheit

Ziel dieser klinischen Studie ist es herauszufinden, ob eine Art der Gehirnstimulation namens transkranielle zeitliche Interferenzstimulation (TIS) des inneren Globus pallidus (GPi) helfen kann, Bewegungssymptome bei Menschen mit Parkinson-Krankheit zu verbessern. Die Studie wird auch untersuchen, wie TIS die mit diesen Verbesserungen verbundene Gehirnaktivität verändert.

Die Hauptfragen, die diese Studie beantworten soll, sind:

  • Wie stark können wiederholte TIS-Sitzungen Bewegungssymptome bei Menschen mit Parkinson-Krankheit verbessern?
  • Können diese Verbesserungen bis zu zwei Monate nach Beendigung der Behandlung anhalten?
  • Welche Veränderungen der Gehirnaktivität treten zusammen mit den Verbesserungen auf?

Die Forscher werden Personen, die aktive TIS erhalten, mit denen vergleichen, die Schein- (placeboähnliche) Stimulation erhalten, um festzustellen, ob aktive TIS zu besseren Bewegungsergebnissen führt.

Die Teilnehmer werden:

  • 10 Sitzungen aktiver oder scheinbarer TIS über zwei Wochen erhalten
  • Bewegungsbewertungen während der zweiwöchigen Behandlung und erneut 2, 4 und 8 Wochen danach durchführen
  • Gehirnaktivitätsbewertungen vor und nach der zweiwöchigen Behandlung durchführen

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Interventionell

Einschreibung (Tatsächlich)

37

Phase

  • Unzutreffend

Kontakte und Standorte

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

Studienorte

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200438
        • Shanghai University of Sport

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

Einschlusskriterien:

  • Eine ärztlich diagnostizierte idiopathische Parkinson-Krankheit (PD) gemäß den diagnostischen Kriterien der Movement Disorder Society (MDS) mit Krankheitsbeginn nach dem 40. Lebensjahr.
  • Stabiles antiparkinsonisches Medikamentenregime, einschließlich Levodopa-haltiger Therapie, unverändert für mindestens 4 Wochen vor und während der Studie.
  • Hoehn-und-Yahr-Stadien (H&Y) 1,5 bis 3 und die Fähigkeit, ohne Hilfe zu gehen.
  • Fehlen von Demenz, definiert als ein Montreal Cognitive Assessment (MoCA)-Wert ≥ 21.

Ausschlusskriterien:

  • Jede Kontraindikation für MRT oder transkranielle temporale Interferenzstimulation (TIS), einschließlich Klaustrophobie, Metallimplantaten im Kopf oder Herzen oder einer Vorgeschichte von Elektrokrampftherapie.
  • Aktuelle Einnahme von Antipsychotika, Antidepressiva oder anderen dopaminmodulierenden Medikamenten.
  • Vorhandensein orthopädischer Erkrankungen, die motorische Bewertungen beeinträchtigen könnten, wie Osteoarthritis oder kürzliche orthopädische Operationen (innerhalb der letzten 6 Monate).
  • Vorgeschichte einer ärztlich diagnostizierten schweren psychiatrischen Erkrankung.
  • Ärztlich diagnostizierte kardiovaskuläre Risiken, die Bewegung oder Studienteilnahme kontraindizieren könnten.
  • Frühere Vorgeschichte von Tiefenhirnstimulation (DBS)-Operationen.

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: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: TIS Gruppe
Die Teilnehmer in diesem Arm erhalten über einen zweiwöchigen Interventionszeitraum eine aktive transkranielle temporale Interferenzstimulation, die auf den inneren Globus pallidus abzielt.
Gerät: Transkranielle temporale Interferenzstimulation (TIS)
Transkranielle temporale Interferenzstimulation (TIS) ist eine nicht-invasive Hirnstimulationstechnik, bei der zwei hochfrequente Wechselströme durch Skalpelektroden geleitet werden, um ein niederfrequentes Interferenzfeld in tiefen Hirnregionen zu erzeugen. In dieser Studie zielt TIS auf den inneren Globus pallidus (GPi) ab, um die neuronale Aktivität bei Menschen mit Parkinson-Krankheit zu modulieren. Die Teilnehmer erhalten über zwei Wochen hinweg 10 Stimulationssitzungen. Die Schein-TIS-Bedingung verwendet denselben Aufbau, wendet jedoch niederfrequente Ströme an, ohne ein Interferenzmuster zu erzeugen.
Schein-Komparator: Sham Group
Participants in this arm will receive sham transcranial temporal interference stimulation using the same electrode placement and experimental setup as the active intervention. However, both electrode pairs delivered currents at 2000 Hz without a frequency offset, resulting in a flat interference envelope while maintaining similar scalp sensations. The sham procedure consists of 10 sessions delivered over a two-week period, without therapeutic stimulation.
Gerät: Transkranielle temporale Interferenzstimulation (TIS)
Transkranielle temporale Interferenzstimulation (TIS) ist eine nicht-invasive Hirnstimulationstechnik, bei der zwei hochfrequente Wechselströme durch Skalpelektroden geleitet werden, um ein niederfrequentes Interferenzfeld in tiefen Hirnregionen zu erzeugen. In dieser Studie zielt TIS auf den inneren Globus pallidus (GPi) ab, um die neuronale Aktivität bei Menschen mit Parkinson-Krankheit zu modulieren. Die Teilnehmer erhalten über zwei Wochen hinweg 10 Stimulationssitzungen. Die Schein-TIS-Bedingung verwendet denselben Aufbau, wendet jedoch niederfrequente Ströme an, ohne ein Interferenzmuster zu erzeugen.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score
Zeitfenster: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change in motor symptoms assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III). The total score ranges from 0 to 132, with higher scores indicating more severe motor impairment (worse outcome).
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Participants With a ≥5-point Reduction From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-III (MDS-UPDRS III) Score
Zeitfenster: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
A responder was defined as a participant with a reduction of at least 5 points from baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III) total score. Scores range from 0 to 132, with higher scores indicating more severe motor impairment; therefore, a reduction in score indicates improvement.
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-I (MDS-UPDRS I) Score
Zeitfenster: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change in non-motor symptoms assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-I (MDS-UPDRS I) (Non-Motor Experiences of Daily Living). The total score ranges from 0 to 52, with higher scores indicating more severe non-motor symptoms (worse outcome).
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-II (MDS-UPDRS II) Score
Zeitfenster: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change in motor symptoms affecting daily living assessed using the Movement Disorder Society-Unified Parkinson's Disease Rating Scale-II (MDS-UPDRS II) (Motor Experiences of Daily Living). The total score ranges from 0 to 52, with higher scores indicating more severe motor difficulties in daily living (worse outcome).
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change From Baseline in the Epworth Sleepiness Scale Score
Zeitfenster: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change in daytime sleepiness assessed using the Epworth Sleepiness Scale . The Epworth Sleepiness Scale is a self-administered questionnaire consisting of 8 items, with total scores ranging from 0 to 24, where higher scores indicate greater daytime sleepiness (worse outcome).
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change From Baseline in the Parkinson's Disease Sleep Scale-2 Score
Zeitfenster: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

Change in sleep disturbances assessed using the Parkinson's Disease Sleep Scale-2.

The Parkinson's Disease Sleep Scale-2 is a patient-reported questionnaire consisting of 15 items, with total scores ranging from 0 to 60, where higher scores indicate more severe sleep disturbances (worse outcome).
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change From Baseline in the Gait Performance Measures
Zeitfenster: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

Changes in gait performance will be assessed using an instrumented gait mat during single-task and dual-task walking conditions.

Spatiotemporal gait parameters, including gait speed, step length, stride length, step width, cadence, and gait variability, will be collected during standardized walking trials.

Improvements in gait performance are indicated by increased gait speed, longer step and stride length, and reduced gait variability under both single-task and dual-task conditions.
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change From Baseline in the Balance Performance Measures
Zeitfenster: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

Changes in balance performance will be assessed using a force platform during standardized standing balance tasks.

Center of pressure (COP) parameters, including COP path length, sway area, and sway velocity, will be derived from force platform recordings to quantify postural stability.

Improved balance performance is indicated by reduced COP displacement, smaller sway area, and lower sway velocity.
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change From Baseline in the Magnetic Resonance Imaging (MRI) Measures
Zeitfenster: Baseline and immediately after the intervention

Changes in brain structure and/or function will be assessed using magnetic resonance imaging (MRI).

MRI data will be acquired to evaluate intervention-related changes in brain regions associated with motor control. Imaging-derived measures may include structural and functional metrics obtained from standardized MRI protocols.
Baseline and immediately after the intervention
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-bradykinesia Subscore
Zeitfenster: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change from baseline in the bradykinesia subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III). The total bradykinesia subscore ranges from 0 to 48, with higher scores indicating more severe bradykinesia.
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-rigidity Subscore
Zeitfenster: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change from baseline in the rigidity subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III). The total rigidity subscore ranges from 0 to 20, with higher scores indicating more severe rigidity.
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-axial Subscore
Zeitfenster: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change from baseline in the axial signs subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III). The total axial signs subscore ranges from 0 to 20, with higher scores indicating more severe axial motor impairment.
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change From Baseline in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III-tremor Subscore
Zeitfenster: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change from baseline in the tremor subscore of the Movement Disorder Society-Unified Parkinson's Disease Rating Scale Part III (MDS-UPDRS III). The total tremor subscore ranges from 0 to 40, with higher scores indicating more severe tremor.
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change From Baseline in the Home Diary Assessment of Motor States (Medication-ON Without Dyskinesia)
Zeitfenster: Baseline, weekly averages during weeks 1 and 2 of the intervention

The motor state will be recorded by participants using a self-completed home diary during waking hours in 30-minute intervals from awakening until bedtime. For each interval, participants will record one of the following motor states: ON with good control, ON with mild dyskinesia, ON with severe dyskinesia, or OFF.

Baseline assessment will be defined as the average percentage of waking time spent in ON states over three consecutive days immediately prior to the intervention. The 1-week assessment will be defined as the average percentage of waking time spent in ON states over the five intervention days of the first intervention week, and the 2-week assessment as the average over the five intervention days of the second intervention week.

The outcome measure is defined as the percentage of total recorded waking time spent in ON states, calculated from the home diary data. A higher percentage of time spent in ON states indicates milder motor symptoms and better motor control.
Baseline, weekly averages during weeks 1 and 2 of the intervention
Change From Baseline in the Home Diary Assessment of Motor States (Medication-OFF)
Zeitfenster: Baseline, weekly averages during weeks 1 and 2 of the intervention

The motor state will be recorded by participants using a self-completed home diary during waking hours in 30-minute intervals from awakening until bedtime. For each interval, participants will record one of the following motor states: ON with good control, ON with mild dyskinesia, ON with severe dyskinesia, or OFF.

Baseline assessment will be defined as the average percentage of waking time spent in the Medication-OFF state over three consecutive days immediately prior to the intervention. Week 1 and Week 2 assessments will be calculated as the average percentage of waking time spent in the Medication-OFF state over the five intervention days of each intervention week.

The outcome measure is defined as the percentage of total recorded waking time spent in the Medication-OFF state, calculated from the home diary data. A lower percentage of time spent in the Medication-OFF state indicates milder motor symptoms and better motor control.
Baseline, weekly averages during weeks 1 and 2 of the intervention
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Summary Index
Zeitfenster: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change in quality of life assessed using the Parkinson's Disease Questionnaire-39 (PDQ-39). The PDQ-39 consists of 39 items across 8 domains, with total scores ranging from 0 to 100, where higher scores indicate poorer health-related quality of life (worse outcome).
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Mobility Domain Score
Zeitfenster: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change from baseline in the mobility domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer mobility-related quality of life.
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Activities of Daily Living Domain Score
Zeitfenster: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change from baseline in the activities of daily living domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of daily living-related quality of life.
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Emotional Well-being Domain Score
Zeitfenster: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change from baseline in the emotional well-being domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of emotional well-being-related quality of life.
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Stigma Domain Score
Zeitfenster: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change from baseline in the stigma domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of stigma-related quality of life.
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Social Support Domain Score
Zeitfenster: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change from baseline in the social support domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of social support-related quality of life.
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Cognitions Domain Score
Zeitfenster: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change from baseline in the cognitions domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of cognitions-related quality of life.
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Communication Domain Score
Zeitfenster: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change from baseline in the communication domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of communication-related quality of life.
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Bodily Discomfort Domain Score
Zeitfenster: Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.
Change from baseline in the bodily discomfort domain score of the Parkinson's Disease Questionnaire-39 (PDQ-39), a disease-specific measure of health-related quality of life in Parkinson's disease. Domain scores were standardized to a scale from 0 to 100, with higher scores indicating poorer activities of bodily discomfort-related quality of life.
Baseline, immediately after 1 and 2 weeks of intervention, 2 weeks, 4 weeks, and 8 weeks after intervention.

Mitarbeiter und Ermittler

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

Sponsor

Shanghai University of Sport

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)

29. Dezember 2025

Primärer Abschluss (Tatsächlich)

15. April 2026

Studienabschluss (Tatsächlich)

15. April 2026

Studienanmeldedaten

Zuerst eingereicht

15. November 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Dezember 2025

Zuerst gepostet (Tatsächlich)

30. Dezember 2025

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 102772024RT146

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

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