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

Description

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.

Conditions

Movement Disorders, Parkinson Disease, Essential Tremor, Tremor, Dystonia, Primary Dystonia, Secondary Dystonia

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Study Overview

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Study Details

Study 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.

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

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

Condition
Movement Disorders
Intervention / Treatment

-

Contacts and Locations

Tucson

University of Aizona Health Sciences, Tucson, Arizona, United States, 85274

Los Angeles

Cedars-Sinai Medical Center, Los Angeles, California, United States, 90048

Sacramento

University of California at Davis, Sacramento, California, United States, 95817

Littleton

Colorado Neurodiagnostics, Littleton, Colorado, United States, 80120

Littleton

Neurosurgery One, Littleton, Colorado, United States, 80122

Miami

University of Miami Hospital, Miami, Florida, United States, 33136

Tampa

University of South Florida - Department of Neurology, Tampa, Florida, United States, 33612

Chicago

Rush University Medical Center, Chicago, Illinois, United States, 60612

Indianapolis

Indiana University, Indianapolis, Indiana, United States, 46202

Kansas City

Kansas University Medical Center, Kansas City, Kansas, United States, 66160

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 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.
  • 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.

Ages Eligible for Study

to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Abbott Medical Devices,

Devyani Nanduri, STUDY_DIRECTOR, Abbott Medical Devices Neuromodulation

Study Record Dates

2030-09