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ID04071847

Long-Term International Study of Abbott Deep Brain Stimulation Systems for Movement Disorders Including Parkinsons Disease, Tremor, and Dystonia

Led by Abbott Medical Devices · Updated on 2026-01-08

1000

Participants Needed

48

Research Sites

52 weeks

Total Duration

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

Research Team

C

Claudia Salazar, PhD

S

Shirisha Chiluka

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