CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 234 enrolled
Drug / intervention
Omnidirectional stimulation +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02989610
NCT02989610N/ACompleted
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Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System

Abbott Medical Devices·observational·Posted Dec 12, 2016·Updated Aug 22, 2024

In Brief

An observational study evaluating Omnidirectional stimulation and Directional stimulation for Parkinson Disease. Completed, enrolled 234 participants across 41 sites in 8 countries.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesAustralia, Belgium, Germany, Italy, Poland, Spain, United Kingdom, United States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedDec 12, 2016
Enrollment StartJan 31, 2017
Primary CompletionAug 7, 2019
Study CompletionApr 19, 2022
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 9.6 years ago

Interventions

Omnidirectional stimulationdevice

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.

Directional stimulationdevice

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.