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”

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 Type: Interventional

Study Design: Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study

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.

Intervention(s) in this Clinical Trial

• 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.

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Control
• Experimental: Investigational

Primary Measures

• Arm Motor Fugl-Meyer (AMFM) score
  • Time Frame: Follow Up Week 4
    Safety Issue?: No
• Arm Motor Ability Test (AMAT) score
  • Time Frame: Follow Up Week 4
    Safety Issue?: No

Secondary Measures

• Box and Block Test score
  • Time Frame: Follow Up Week 4
    Safety Issue?: No
• Stroke Specific Quality of Life (SSQOL) score
  • Time Frame: Follow Up Week 4
    Safety Issue?: No
• Serious adverse event rate
  • Time Frame: Follow up week 4 and 6 months
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Northstar Neuroscience

Information obtained from ClinicalTrials.gov on December 03, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00170716

Study ID Number: V0267

ClinicalTrials.gov Identifier: NCT00170716

Health Authority: United States: Food and Drug Administration