Purpose

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 and dystonia.

Conditions

Eligibility

Eligible Ages
All ages
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  1. Subject is scheduled for a new implant or implantable pulse generator (IPG) device replacement surgery with a market-released Abbott DBS system within 3 months. 2. Subject, or a legally acceptable representative, must provide written informed consent prior to any clinical investigation-related procedure.

Exclusion Criteria

  1. Subject is currently enrolled or plans to enroll in another concurrent study that may confound the results of this clinical investigation, as determined by Abbott. 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 clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

Study Design

Phase
Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Deep brain stimulation Subjects implanted with an Abbott DBS system
  • Device: Deep Brain Stimulation (DBS)
    Deep brain stimulation therapy involves the delivery of electrical pulses to specific structures in the brain and has been used to improve motor symptoms associated with Parkinson's disease, disabling tremor including essential tremor, and dystonia.

Recruiting Locations

Kansas University Medical Center
Kansas City, Kansas 66160
Contact:
April Langhammer
913-588-6989
ALanghammer@kumc.edu

More Details

Status
Recruiting
Sponsor
Abbott Medical Devices

Study Contact

Edward Karst
972 526 4663
edward.karst@abbott.com

Detailed Description

ADROIT (Abbott DBS Registry of Outcomes for Indications over Time) is an international, prospective, multicenter, observational, post-market study intended to collect worldwide long-term safety and effectiveness data on patients implanted with market-released Abbott DBS systems. Patients with new DBS systems or replacement devices will be followed for up to 5 years after initiating stimulation. Improvement in symptoms from baseline will be assessed over time. Individuals who are scheduled to receive a new Abbott DBS system or a battery replacement may be considered for inclusion in the study.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.