Abbott DBS Post-Market Study of Outcomes for Indications Over Time

Обзор

The purpose of this international study is to evaluate long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems for all indications, including Parkinson's disease, essential tremor or other disabling tremor and dystonia.

Подробное описание

ADROIT is an international, prospective, multicenter, observational, post-market study intended to collect worldwide long-term safety and effectiveness data on subjects implanted with market-released Abbott DBS systems in routine clinical practice.

Subjects will be followed for 5 years after the initial programming visit.

Вмешательства

• Устройство Deep Brain Stimulation (DBS)
  Deep brain stimulation therapy involves the delivery of electrical signals to targeted structures in the brain to modulate neural circuit activity, and has been used successfully for the treatment of various types of movement disorders, including Parkinson's disease (PD), disabling or essential tremor, and dystonia

Первичные конечные точки

• Change from baseline to 6 months in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. [Срок оценки: Baseline to 6 months]
• Change from baseline to1 year in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. [Срок оценки: Baseline to1 year]
• Change from baseline to 2 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. [Срок оценки: Baseline to 2 years]
• Change from baseline to 3 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. [Срок оценки: Baseline to 3 years]
• Change from baseline to 4 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. [Срок оценки: Baseline to 4 years]
• Change from baseline to 5 years in disease-specific motor rating scale. For subjects with Parkinson's disease, MDS-UPDRS Part III. [Срок оценки: Baseline to 5 years]
• Change from baseline to 6 months in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS. [Срок оценки: Baseline to 6 months]
• Change from baseline to 1 year in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS. [Срок оценки: Baseline to 1 year]
• Change from baseline to 2 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS. [Срок оценки: Baseline to 2 years]
• Change from baseline to 3 years in disease-specific motor rating scale. For subjects with disabling tremor, FTM-TRS. [Срок оценки: Baseline to 3 years]

Критерии участия

Критерии включения

• Subject is scheduled for a new implant or IPG device replacement surgery with a market-released Abbott DBS system within 180 days.
• Subject, or a legally acceptable representative, must provide written informed consent prior to any study-related procedure.

Критерии исключения

• Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study.
• Subject has anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the study or to comply with follow-up requirements, or impact the scientific soundness of the study results.
• Study center is located in the United States, and indication for DBS implant is not Parkinson's disease or disabling tremor.
• Study center is located in the United States, and the intended lead implant location is not at, or in close proximity to, the STN, GPi, or VIM thalamus.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 23 центра

• University of Aizona Health Sciences — Tucson
• Cedars-Sinai Medical Center — Los Angeles
• University of California at Davis — Sacramento
• Colorado Neurodiagnostics — Littleton
• Neurosurgery One — Littleton
• University of Miami Hospital — Miami
• University of South Florida - Department of Neurology — Tampa
• Rush University Medical Center — Chicago
• … и ещё 15 центров

Германия · 6 центров

• Universitäts Klinikum Tübingen — Tübingen
• Medizinische Einrichtungen der Universität Düsseldorf — Düsseldorf
• Universitätsklinikum Münster — Münster
• UNIVERSITATSMEDIZIN der Johannes Gutenberg-Universität Mainz — Mainz
• Universitätsklinikum des Saarlandes — Homburg
• UKE Hamburg (Universitatsklinik Eppendorf) — Hamburg

Франция · 4 центра

• CHU Gabriel Montpied — Clermont-Ferrand
• CHU de St Etienne — Saint-Etienne
• Fondation Rothchild — Paris
• CHU Hopital Pasteur — Nice

Великобритания · 4 центра

• The Walton Centre — Liverpool
• Southmead Hospita — Bristol
• Queen Elizabeth University Hospital — Glasgow
• King's College Hospital — London

Италия · 3 центра

• Az.Osp. Universitaria di Ferrara — Cona
• Policlinico Universitario A. Gemelli — Rome
• Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta — Milan

Испания · 3 центра

• Hospital Virgen de Rocio — Seville
• Hospital Universitari Germans Trias I Pujol — Badalona
• Hospital Universitario de la Princesa — Madrid

Австралия · 2 центра

• Princess Alexandra Hospital — Woolloongabba
• Royal Melbourne Hospital - City Campus — Parkville

Тайвань · 2 центра

• Chang Gung Memorial Hospital — Linkou District
• Hualien Tzu Chi Hospital — Hualien City

Финляндия · 1 центр

• Helsinki University Central Hospital — Helsinki

Публикации

• Gharabaghi A, Groppa S, Casas E, Schnitzler A, Munoz-Delgado L, Marshall VL, Karl J, Zhang L, Alvarez R, Feldman MS, Soileau MJ, Luo L, Walter BL, Wu C, Lei H, Herz DM, Nanduri D, Salazar CA, Luca C, Weiss D. Real-world multicenter assessment of sustained clinical outcomes after digital deep brain stimulation. NPJ Digit Med. 2026 Jan 14;9(1):133. doi: 10.1038/s41746-025-02315-5. PMID 41535352

Идентификаторы

NCT: NCT04071847 · ABT-CIP-10300

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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