Actively Recruiting
Abbott DBS Post-Market Study of Outcomes for Indications Over Time
Led by Abbott Medical Devices · Updated on 2026-01-08
1000
Participants Needed
48
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety and effectiveness of Abbott deep brain stimulation DBS systems used for various movement disorders, including Parkinsons disease, essential tremor, disabling tremor, and dystonia. This international, prospective, multicenter study collects data from patients implanted with Abbott DBS devices during routine clinical care to understand outcomes over time. Participants implanted with the Abbott DBS system will be observed without altering their treatment, as this is an observational study. The study follows subjects for five years from their initial programming visit to gather information on device performance and patient motor function over time. During the study, participants will have regular assessments using disease-specific motor rating scales such as MDS-UPDRS Part III for Parkinsons disease and FTM-TRS for tremor. Researchers will monitor changes in motor symptoms and record any serious device- or procedure-related adverse events. Study involvement lasts for five years, allowing long-term collection of safety and effectiveness data.
CONDITIONS
Brief Title
Abbott DBS Post-Market Study of Outcomes for Indications Over Time
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Scheduled for a new implant or implantable pulse generator replacement surgery with a market-released Abbott DBS system within 180 days
- Able to provide written informed consent or have a legally acceptable representative provide consent before any study procedures
You will not qualify if you...
- Currently enrolled or planning to enroll in an investigational study that could affect this study's results
- Having medical, social, psychological, or anatomical conditions that limit participation or compliance with follow-up
- For US centers: indication for DBS implant is not Parkinson's disease or disabling tremor
- For US centers: intended lead implant location is not at or near the STN, GPi, or VIM thalamus areas of the brain
- Any condition that, in the investigator's opinion, may impact the scientific validity of the study results or participant safety or compliance with the study requirements or follow-up visits
- Subjects unable to comply with study follow-up requirements or procedures as determined by the investigator
- Subjects with other medical or psychological conditions that may interfere with participation or study results as judged by the investigator
- Subjects with anatomic conditions limiting study participation as judged by the investigator
- Subjects with social conditions limiting study participation as judged by the investigator
- Subjects with psychological conditions limiting study participation as judged by the investigator
- Subjects enrolled in conflicting studies that may confound results in this study
- Subjects at US sites with DBS indication or lead location outside specified criteria
Research Team
C
Claudia Salazar, PhD
S
Shirisha Chiluka
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