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

December 18, 2007 updated by: Northstar Neuroscience

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

174

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
        • University of Arizona Health Sciences Center
    • California
      • Los Angeles, California, United States, 90089
        • University of Southern California
      • San Francisco, California, United States, 94125
        • University of California San Francisco Medical Center
      • Stanford, California, United States, 94305
        • Stanford University Medical Center
    • Colorado
      • Englewood, Colorado, United States, 80113
        • Colorado Neurological Institute & Swedish Medical Center
    • Florida
      • Jacksonville, Florida, United States, 32209-6511
        • University of Florida, Jacksonville
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory Clinic
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois at Chicago
      • Chicago, Illinois, United States, 60611
        • Northwestern University Medical Center and the Rehabilitation Institute of Chicago
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Spaulding Rehabilitation Center and Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Wayne State University
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Hospital
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai School of Medicine
      • Syracuse, New York, United States, 13210
        • State University of New York Upstate Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati Medical Center
    • Oregon
      • Portland, Oregon, United States, 97201
        • Oregon Health Sciences University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Medical Center
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center
    • Texas
      • Houston, Texas, United States, 77030
        • University of Texas Health Sciences Center at Houston
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Health Sciences Center
    • Washington
      • Seattle, Washington, United States, 98122
        • Swedish Health Services

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
Other: Rehabilitation
Rehabilitation is for 2.5 hrs per day for 26 days over a period of 6 weeks.
Other Names:
  • Post-stroke rehabilitation.
Experimental: Investigational
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 Names:
  • Renova-ST Cortical Stimulation System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Arm Motor Fugl-Meyer (AMFM) score
Time Frame: Follow Up Week 4
Follow Up Week 4
Arm Motor Ability Test (AMAT) score
Time Frame: Follow Up Week 4
Follow Up Week 4

Secondary Outcome Measures

Outcome Measure
Time Frame
Box and Block Test score
Time Frame: Follow Up Week 4
Follow Up Week 4
Stroke Specific Quality of Life (SSQOL) score
Time Frame: Follow Up Week 4
Follow Up Week 4
Serious adverse event rate
Time Frame: Follow up week 4 and 6 months
Follow up week 4 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northstar Neuroscience

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Study Completion (Anticipated)

March 1, 2008

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

December 28, 2007

Last Update Submitted That Met QC Criteria

December 18, 2007

Last Verified

December 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V0267

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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