Long-term evaluation of Abbott deep brain stimulation systems for movement disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international, multicenter observational study aims to assess the long-term safety and effectiveness of Abbott deep brain stimulation (DBS) systems in patients with movement disorders such as Parkinson's disease and essential tremor. Participants will be followed for five years after their initial programming visit to gather data on outcomes in routine clinical practice. The study includes subjects who are scheduled for a new implant or replacement surgery with Abbott DBS systems and requires informed consent prior to participation.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of South Florida - Department of Neurology
  Tampa, Florida, United States Recruiting
• Rush University Medical Center
  Chicago, Illinois, United States Recruiting
• Indiana University
  Indianapolis, Indiana, United States Recruiting
• University of Louisville
  Louisville, Kentucky, United States Recruiting
• Albany Medical Center
  Albany, New York, United States Recruiting
• The Cleveland Clinic Foundation
  Cleveland, Ohio, United States Recruiting

Study contacts

• Study coordinator: Claudia Salazar, PhD
• Email: claudia.salazar4@abbott.com
• Phone: +1-650-647-3396

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.