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

Launched by ABBOTT MEDICAL DEVICES · Aug 26, 2019

Keywords

ClinConnect Summary

This clinical trial, called the Abbott DBS Post-Market Study, is investigating the long-term safety and effectiveness of a device called deep brain stimulation (DBS) for patients with movement disorders like Parkinson's disease, essential tremor, and dystonia. The goal is to see how well this treatment works over time for individuals who are getting a new DBS device or replacing an old one.

To participate in this study, you need to be scheduled for surgery to get a new or replacement Abbott DBS device within the next 180 days and give your consent to join the study. It’s important to note that if you are currently in another study or have certain medical conditions that could affect your ability to participate, you may not be eligible. If you join, you can expect regular follow-ups to monitor your health and the device's performance. This study is open to people of all ages and genders, and it aims to provide important insights that could help improve treatment options for movement disorders in the future.

Gender

ALL

Eligibility criteria

• 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.