Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2026-03-06 @ 10:11 PM
Study NCT ID:
NCT02963259
Status:
COMPLETED
Last Update Posted:
2024-07-08
First Post:
2016-11-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
IPG Replacement Study (PREFERENCE-H)
Sponsor:
Abbott Medical Devices
Organization:
Study Overview
Official Title:
Prospective Evaluation Comparing the Effects of Constant Current Versus Constant Voltage in Deep Brain Stimulation Using Hybrid Systems
Status:
COMPLETED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PREFERENCE-H
Brief 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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: