NCT04071847

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Movement Disorders
• Parkinson Disease
• Essential Tremor
• Tremor
• Dystonia
• Primary Dystonia
• Secondary Dystonia

Interventions

Type	Name	Description
DEVICE	Deep Brain Stimulation (DBS)	Deep brain stimulation therapy involves the delivery of electrical signals to targeted structures in the brain to modulate neural circuit activity, and has been used successfully for the treatment of various types of movement disorders, including Parkinson's disease (PD), disabling or essential tremor, and dystonia

Timeline

• Start date: 2019-11-26
• Primary completion: 2029-09-01
• Completion: 2030-09-01
• First posted: 2019-08-28
• Last updated: 2026-01-08

Locations

48 sites across 9 countries: United States, Australia, Finland, France, Germany, Italy, Spain, Taiwan, United Kingdom

Regulatory

• FDA-regulated device study