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

Abbott

Status: Enrolling

Conditions: Tremor; Essential Tremor; Dystonia; Parkinson Disease; Movement Disorders; Secondary Dystonia; Primary Dystonia

Treatments: Device: Deep Brain Stimulation (DBS)

Study type: Observational

Funder types: Industry

Identifiers

NCT04071847

ABT-CIP-10300

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion 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.

Exclusion criteria

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.

Trial design

1,000 participants in 1 patient group

Deep brain stimulation

Description:

Subjects implanted with an Abbott DBS system

Treatment:

Device: Deep Brain Stimulation (DBS)