Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00170716
Status:
UNKNOWN
Last Update Posted:
2007-12-28
First Post:
2005-09-09
Brief Title:
Safety and Effectiveness of Cortical Stimulation in the Treatment of Stroke Patients With Upper Extremity Hemiparesis
Sponsor:
Northstar Neuroscience
Organization:
Northstar Neuroscience
Study Overview
Official Title:
Safety and Effectiveness of Targeted Sub-Threshold Epidural Cortical Stimulation Delivered Concurrent With Rehabilitation Activities to Enhance Motor Recovery in Patients Suffering From Upper Extremity Hemiparesis Following a Stroke
Status:
UNKNOWN
Status Verified Date:
2007-12
Last Known Status:
ACTIVE_NOT_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:
EVEREST
Brief Summary:
The purpose of this study is to assess the safety and effectiveness of cortical stimulation delivered concurrent with rehabilitation activities to enhance motor recovery in patients suffering from hemiparesis affecting the upper extremity following a stroke
Detailed Description:
Stroke is a leading cause of serious long-term disability in the United States According to the American Stroke Association the prevalence of stroke in the US is approximately 48 million with approximately 700000 additional strokes occurring annually The 2001 overall death rate for stroke was 58 Of those who survive 30 to 50 percent do not regain functional independence 15 to 30 percent are permanently disabled and 20 require institutional care at three months after onset
The most common neurological deficit among these stroke survivors and thus a substantial contributor to post-stroke disability is a motor weakness on one hemiparesis side of the body Presently the only treatment available for patients with motor deficits is rehabilitative therapy However many patients are not responsive to standard rehabilitative therapy or achieve a less than satisfactory improvement in function
The primary objective of this study is to determine the safety and effectiveness of targeted sub-threshold epidural cortical stimulation delivered concurrent with rehabilitation activities to enhance motor recovery in patients suffering from hemiparesis a motor weakness in one half of the body affecting the upper extremity shoulder arm wrist hand following a stroke In addition to evaluating changes from baseline level safety and efficacy measures will be compared to patients who undergo the same rehabilitation activities but without cortical stimulation The two study groups will be compared to determine the degree to which motor function of the affected limb can be improved beyond rehabilitation alone by epidural stimulation of a targeted cortical region
The most common neurological deficit among these stroke survivors and thus a substantial contributor to post-stroke disability is a motor weakness on one hemiparesis side of the body Presently the only treatment available for patients with motor deficits is rehabilitative therapy However many patients are not responsive to standard rehabilitative therapy or achieve a less than satisfactory improvement in function
The primary objective of this study is to determine the safety and effectiveness of targeted sub-threshold epidural cortical stimulation delivered concurrent with rehabilitation activities to enhance motor recovery in patients suffering from hemiparesis a motor weakness in one half of the body affecting the upper extremity shoulder arm wrist hand following a stroke In addition to evaluating changes from baseline level safety and efficacy measures will be compared to patients who undergo the same rehabilitation activities but without cortical stimulation The two study groups will be compared to determine the degree to which motor function of the affected limb can be improved beyond rehabilitation alone by epidural stimulation of a targeted cortical region
Study Oversight
Has Oversight DMC:
None
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?:
None