Ignite Creation Date:
2025-12-25 @ 3:48 AM
Ignite Modification Date:
2026-02-25 @ 8:27 PM
Study NCT ID:
NCT02115802
Status:
UNKNOWN
Last Update Posted:
2016-02-23
First Post:
2014-04-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LFP Correlates of Movement Disorders
Sponsor:
Colorado Neurological Institute
Organization:
Study Overview
Official Title:
Local Field Potential Correlates of Motor Behavior and Pathological Signs in Movement Disorders for Development of Closed Loop Stimulation Systems
Status:
UNKNOWN
Status Verified Date:
2016-02
Last Known Status:
RECRUITING
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:
None
Brief Summary:
The purpose of this study is to record electrical brain activity during DBS surgery and after DBS surgery using the Medtronic Activa PC+S deep brain stimulation (DBS) system, a modified DBS pulse generator. The goal of the study is to investigate if the electrical brain activity can help customize DBS therapy.
Detailed Description:
The Activa PC+S system will be implanted and programmed under the same clinical procedures and standard of care as the Activa PC system. After implantation and standard clinical programming, participants in our research study will be asked to return for additional research visits where the recording sub-circuit of the device will be activated and local field potentials (LFP) will be recorded in the device and transmitted through telemetry to a base station for storage and future analysis. The sensing, or recording, sub-circuit will be disabled, non-invasively, at the end of each research visit to minimize impact to battery life of the device.
Study Oversight
Has Oversight DMC:
True
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?: