CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 17 enrolled
Drug / intervention
SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG systemdevice
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/NCT02963259
NCT02963259N/ACompleted
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Prospective Evaluation Comparing the Effects of Constant Current Versus Constant Voltage in Deep Brain Stimulation Using Hybrid Systems

Abbott Medical Devices·observational·Posted Nov 15, 2016·Updated Jul 8, 2024

In Brief

An observational study evaluating SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system for Parkinson Disease. Completed, enrolled 17 participants across 14 sites in 3 countries.

Detailed Summary

This post-marketing evaluation has been designed to consistently investigate the subject's preference when switching from a Medtronic® constant voltage or constant current device to a St Jude Medical Infinity™ or St Jude Medical Brio™ constant current system. As electrodes will not be re-positioned, differences in subject's preference are to be explained by the difference in shape of the delivered pulse or waveform between the two systems.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsParkinson Disease
CountriesGermany, Italy, United States
Collaborators--

Timeline

N/ACompletedFinished
2017201820192020202120222023202420252026
First PostedNov 15, 2016
Enrollment StartMar 29, 2017
Primary CompletionNov 29, 2019
Study CompletionJan 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.6 years ago

Interventions

SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG systemdevice

Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system