Safety and Effectiveness of Cortical Stimulation in the Treatment of Stroke Patients With Upper Extremity Hemiparesis
Information source: Northstar Neuroscience
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Stroke; Hemiparesis
Intervention: Cortical Stimulation and rehabilitation (Device); Rehabilitation (Other)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Northstar Neuroscience
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Arm Motor Fugl-Meyer (AMFM) scoreArm Motor Ability Test (AMAT) score
Secondary outcome: Box and Block Test scoreStroke Specific Quality of Life (SSQOL) score Serious adverse event rate
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.
Eligibility
Minimum age: 21 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects must have an ischemic stroke.
- Moderate to moderately severe upper-extremity hemiparesis.
- Aged 21 years or older.
Exclusion Criteria:
- 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.
Locations and Contacts
University of Arizona Health Sciences Center, Tucson, Arizona 85724, United States
University of Southern California, Los Angeles, California 90089, United States
University of California San Francisco Medical Center, San Francisco, California 94125, United States
Stanford University Medical Center, Stanford, California 94305, United States
Colorado Neurological Institute & Swedish Medical Center, Englewood, Colorado 80113, United States
University of Florida, Jacksonville, Jacksonville, Florida 32209-6511, United States
Emory Clinic, Atlanta, Georgia 30322, United States
Northwestern University Medical Center and the Rehabilitation Institute of Chicago, Chicago, Illinois 60611, United States
University of Illinois at Chicago, Chicago, Illinois 60612, United States
Spaulding Rehabilitation Center and Massachusetts General Hospital, Boston, Massachusetts 02114, United States
Wayne State University, Detroit, Michigan 48201, United States
St. Luke's Hospital, Kansas City, Missouri 64111, United States
Mount Sinai School of Medicine, New York, New York 10029, United States
State University of New York Upstate Medical Center, Syracuse, New York 13210, United States
University of Cincinnati Medical Center, Cincinnati, Ohio 45267, United States
Oregon Health Sciences University, Portland, Oregon 97201, United States
University of Pennsylvania Medical Center, Philadelphia, Pennsylvania 19104, United States
University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States
University of Texas Health Sciences Center at Houston, Houston, Texas 77030, United States
University of Utah Health Sciences Center, Salt Lake City, Utah 84132, United States
Swedish Health Services, Seattle, Washington 98122, United States
Additional Information
Related publications: Brown JA, Lutsep H, Cramer SC, Weinand M. Motor cortex stimulation for enhancement of recovery after stroke: case report. Neurol Res. 2003 Dec;25(8):815-8. Cramer SC, Benson RR, Himes DM, Burra VC, Janowsky JS, Weinand ME, Brown JA, Lutsep HL. Use of functional MRI to guide decisions in a clinical stroke trial. Stroke. 2005 May;36(5):e50-2. Epub 2005 Apr 14. Brown JA, Lutsep HL, Weinand M, Cramer SC. Motor cortex stimulation for the enhancement of recovery from stroke: a prospective, multicenter safety study. Neurosurgery. 2006 Mar;58(3):464-73.
Starting date: September 2004
Last updated: December 18, 2007
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