Safety and Effectiveness of Cortical Stimulation in the Treatment of Stroke Patients With Upper Extremity Hemiparesis (EVEREST)
Recruitment status was: Active, not recruiting
|Stroke Hemiparesis||Device: Cortical Stimulation and rehabilitation Other: Rehabilitation||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
|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|
- Arm Motor Fugl-Meyer (AMFM) score [ Time Frame: Follow Up Week 4 ]
- Arm Motor Ability Test (AMAT) score [ Time Frame: Follow Up Week 4 ]
- Box and Block Test score [ Time Frame: Follow Up Week 4 ]
- Stroke Specific Quality of Life (SSQOL) score [ Time Frame: Follow Up Week 4 ]
- Serious adverse event rate [ Time Frame: Follow up week 4 and 6 months ]
|Study Start Date:||September 2004|
|Estimated Study Completion Date:||March 2008|
|Active Comparator: Control||
Rehabilitation is for 2.5 hrs per day for 26 days over a period of 6 weeks.
Other Name: Post-stroke rehabilitation.
Device: Cortical Stimulation and rehabilitation
Cortical stimulation is provided concomitantly with rehabilitation therapy. Rehabilitation is for 2.5 hrs per day for 26 days over a period of 6 weeks.
Other Name: Renova-ST Cortical Stimulation System
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 U.S. is approximately 4.8 million with approximately 700,000 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00170716
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