DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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) score

Arm Motor Ability Test (AMAT) score

Secondary outcome:

Box and Block Test score

Stroke 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

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017