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Sponsored by: |
Northstar Neuroscience |
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Information provided by: | Northstar Neuroscience |
ClinicalTrials.gov Identifier: | NCT00170716 |
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.
Condition | Intervention | Phase |
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Stroke Hemiparesis |
Device: Cortical Stimulation and rehabilitation Other: Rehabilitation |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment, Safety/Efficacy Study |
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 |
Estimated Enrollment: | 174 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | March 2008 |
Arms | Assigned Interventions |
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Control: Active Comparator |
Other: Rehabilitation
Rehabilitation is for 2.5 hrs per day for 26 days over a period of 6 weeks.
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Investigational: Experimental |
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.
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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.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Northstar Neuroscience ( VP Clinical Affairs ) |
Study ID Numbers: | V0267 |
Study First Received: | September 9, 2005 |
Last Updated: | December 18, 2007 |
ClinicalTrials.gov Identifier: | NCT00170716 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Motor Cortex Electrical Stimulation Ischemic Stroke Upper Extremity Hemiparesis |
Rehabilitation Motor Recovery Functional MRI |
Paresis Cerebral Infarction Stroke Vascular Diseases Central Nervous System Diseases Ischemia Brain Diseases |
Cerebrovascular Disorders Signs and Symptoms Neurologic Manifestations Brain Ischemia Brain Infarction Infarction |
Paresis Cerebral Infarction Stroke Nervous System Diseases Vascular Diseases Central Nervous System Diseases Brain Diseases |
Cerebrovascular Disorders Signs and Symptoms Neurologic Manifestations Brain Ischemia Cardiovascular Diseases Brain Infarction |