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Recruiting NCT04071847

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

— Observational Movement Disorders Parkinson Disease Essential Tremor Tremor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Deep Brain Stimulation (DBS).
Who it may be relevant to
Registry conditions: Movement Disorders, Parkinson Disease, Essential Tremor, Tremor. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia, Finland, France, Germany +4
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Detailed description

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.

Interventions

  • Device 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

Primary outcome measures

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

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 23 centers
  • 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
  • … and 15 more centers
Germany · 6 centers
  • 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
France · 4 centers
  • CHU Gabriel Montpied — Clermont-Ferrand
  • CHU de St Etienne — Saint-Etienne
  • Fondation Rothchild — Paris
  • CHU Hopital Pasteur — Nice
United Kingdom · 4 centers
  • The Walton Centre — Liverpool
  • Southmead Hospita — Bristol
  • Queen Elizabeth University Hospital — Glasgow
  • King's College Hospital — London
Italy · 3 centers
  • Az.Osp. Universitaria di Ferrara — Cona
  • Policlinico Universitario A. Gemelli — Rome
  • Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta — Milan
Spain · 3 centers
  • Hospital Virgen de Rocio — Seville
  • Hospital Universitari Germans Trias I Pujol — Badalona
  • Hospital Universitario de la Princesa — Madrid
Australia · 2 centers
  • Princess Alexandra Hospital — Woolloongabba
  • Royal Melbourne Hospital - City Campus — Parkville
Taiwan · 2 centers
  • Chang Gung Memorial Hospital — Linkou District
  • Hualien Tzu Chi Hospital — Hualien City
Finland · 1 center
  • Helsinki University Central Hospital — Helsinki

Publications

  • 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

Identifiers

NCT: NCT04071847 · ABT-CIP-10300

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗