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

a study on Movement Disorders Parkinson's Disease Essential Tremor Tremor Dystonia

Summary

Location
at UC Davis
Dates
study started
completion around

Description

Summary

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.

Details

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.

Keywords

Movement Disorders, Parkinson Disease, Essential Tremor, Tremor, Dystonia, Primary Dystonia, Secondary Dystonia, Dystonic Disorders, Deep Brain Stimulation (DBS), Deep brain stimulation

Eligibility

You can join if…

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

You CAN'T join if...

  1. Subject is currently enrolled or plans to enroll in an investigational study that may confound the results of this study.
  2. 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.
  3. Study center is located in the United States, and indication for DBS implant is not Parkinson's disease or disabling tremor.
  4. 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.

Locations

  • University of California at Davis accepting new patients
    Sacramento California 95817 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Abbott Medical Devices
ID
NCT04071847
Study Type
Observational
Participants
Expecting 1000 study participants
Last Updated