Safety and Effectiveness of Cortical Stimulation in the Treatment of Stroke Patients With Upper Extremity Hemiparesis

Stroke Clinical Trial

— EVEREST  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00170716
• Other study ID #: V0267
• Status: Active, not recruiting
• Phase: Phase 3
• First received: September 9, 2005
• Last updated: December 18, 2007
• Start date: September 2004
• Est. completion date: March 2008

Study information

• Verified date: December 2007
• Source: Northstar Neuroscience
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 174
• Est. completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemiparesis
• Stroke

Intervention

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:
• Rehabilitation
Rehabilitation is for 2.5 hrs per day for 26 days over a period of 6 weeks.

Locations

Country	Name	City	State
United States	Emory Clinic	Atlanta	Georgia
United States	Spaulding Rehabilitation Center and Massachusetts General Hospital	Boston	Massachusetts
United States	Northwestern University Medical Center and the Rehabilitation Institute of Chicago	Chicago	Illinois
United States	University of Illinois at Chicago	Chicago	Illinois
United States	University of Cincinnati Medical Center	Cincinnati	Ohio
United States	Wayne State University	Detroit	Michigan
United States	Colorado Neurological Institute & Swedish Medical Center	Englewood	Colorado
United States	University of Texas Health Sciences Center at Houston	Houston	Texas
United States	University of Florida, Jacksonville	Jacksonville	Florida
United States	St. Luke's Hospital	Kansas City	Missouri
United States	University of Southern California	Los Angeles	California
United States	Mount Sinai School of Medicine	New York	New York
United States	University of Pennsylvania Medical Center	Philadelphia	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Oregon Health Sciences University	Portland	Oregon
United States	University of Utah Health Sciences Center	Salt Lake City	Utah
United States	University of California San Francisco Medical Center	San Francisco	California
United States	Swedish Health Services	Seattle	Washington
United States	Stanford University Medical Center	Stanford	California
United States	State University of New York Upstate Medical Center	Syracuse	New York
United States	University of Arizona Health Sciences Center	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Northstar Neuroscience

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arm Motor Fugl-Meyer (AMFM) score		Follow Up Week 4	No
Primary	Arm Motor Ability Test (AMAT) score		Follow Up Week 4	No
Secondary	Box and Block Test score		Follow Up Week 4	No
Secondary	Stroke Specific Quality of Life (SSQOL) score		Follow Up Week 4	No
Secondary	Serious adverse event rate		Follow up week 4 and 6 months	Yes