Safety and Effectiveness of Cortical Stimulation in the Treatment of Stroke Patients With Upper Extremity Hemiparesis
- Conditions
- StrokeHemiparesis
- Interventions
- Other: RehabilitationDevice: Cortical Stimulation and rehabilitation
- Registration Number
- NCT00170716
- Lead Sponsor
- Northstar Neuroscience
- 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 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 174
- Subjects must have an ischemic stroke.
- Moderate to moderately severe upper-extremity hemiparesis.
- Aged 21 years or older.
- Primary hemorrhagic stroke.
- Any additional stroke associated with incomplete motor recovery.
- Any neurologic or physical condition impairing function of the target extremity.
- History of seizure disorder.
- History of spinal cord injury, traumatic brain injury, or spontaneous subdural or epidural hematoma that has resulted in a neurologic deficit.
- Contraindication to magnetic resonance (MR) imaging.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Control Rehabilitation - Investigational Cortical Stimulation and rehabilitation -
- Primary Outcome Measures
Name Time Method Arm Motor Fugl-Meyer (AMFM) score Follow Up Week 4 Arm Motor Ability Test (AMAT) score Follow Up Week 4
- Secondary Outcome Measures
Name Time Method Box and Block Test score Follow Up Week 4 Stroke Specific Quality of Life (SSQOL) score Follow Up Week 4 Serious adverse event rate Follow up week 4 and 6 months
Trial Locations
- Locations (21)
University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
University of Florida, Jacksonville
🇺🇸Jacksonville, Florida, United States
St. Luke's Hospital
🇺🇸Kansas City, Missouri, United States
Northwestern University Medical Center and the Rehabilitation Institute of Chicago
🇺🇸Chicago, Illinois, United States
University of Southern California
🇺🇸Los Angeles, California, United States
University of California San Francisco Medical Center
🇺🇸San Francisco, California, United States
Wayne State University
🇺🇸Detroit, Michigan, United States
Colorado Neurological Institute & Swedish Medical Center
🇺🇸Englewood, Colorado, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
Spaulding Rehabilitation Center and Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
University of Pennsylvania Medical Center
🇺🇸Philadelphia, Pennsylvania, United States
State University of New York Upstate Medical Center
🇺🇸Syracuse, New York, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Oregon Health Sciences University
🇺🇸Portland, Oregon, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Swedish Health Services
🇺🇸Seattle, Washington, United States
University of Texas Health Sciences Center at Houston
🇺🇸Houston, Texas, United States
University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States
Emory Clinic
🇺🇸Atlanta, Georgia, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States