NCT02989610

Clinical Evaluation of the Infinity Deep Brain Stimulation System

Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 234 (actual)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this post-market study is to characterize the clinical performance of the Infinity Deep Brain Stimulation (DBS) system, including the Implantable Pulse Generator (IPG), directional DBS leads, extensions, iPad clinician programmer, iPod patient controller and related system components. Participants in the PROGRESS study are not assigned to interventional therapy groups. Participants in the PROGRESS study are followed in an observational format as they receive omnidirectional and then directional DBS programming that is part of routine medical care. Data on symptoms are collected during two different stages of programming, and those outcomes compared to assess the effect of omnidirectional or directional programming.

Conditions

• Parkinson Disease

Interventions

Type	Name	Description
DEVICE	Omnidirectional stimulation	At the 3-month follow-up, therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional stimulation with the Infinity DBS lead.
DEVICE	Directional stimulation	At the 3-month follow-up, therapeutic window, symptom relief and side effect thresholds are evaluated using directional contacts at the best segmented level of the Infinity DBS lead.

Timeline

• Start date: 2017-01-31
• Primary completion: 2019-08-07
• Completion: 2022-04-19
• First posted: 2016-12-12
• Last updated: 2024-08-22
• Results posted: 2020-11-19

Locations

41 sites across 8 countries: United States, Australia, Belgium, Germany, Italy, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated device study