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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2007 by Northstar Neuroscience.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Northstar Neuroscience
ClinicalTrials.gov Identifier:
NCT00170716
First received: September 9, 2005
Last updated: December 18, 2007
Last verified: December 2007
  Purpose

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
Stroke
Hemiparesis
Device: Cortical Stimulation and rehabilitation
Other: Rehabilitation
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Northstar Neuroscience:

Primary Outcome Measures:
  • Arm Motor Fugl-Meyer (AMFM) score [ Time Frame: Follow Up Week 4 ] [ Designated as safety issue: No ]
  • Arm Motor Ability Test (AMAT) score [ Time Frame: Follow Up Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Box and Block Test score [ Time Frame: Follow Up Week 4 ] [ Designated as safety issue: No ]
  • Stroke Specific Quality of Life (SSQOL) score [ Time Frame: Follow Up Week 4 ] [ Designated as safety issue: No ]
  • Serious adverse event rate [ Time Frame: Follow up week 4 and 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 174
Study Start Date: September 2004
Estimated Study Completion Date: March 2008
Arms Assigned Interventions
Active Comparator: Control Other: Rehabilitation
Rehabilitation is for 2.5 hrs per day for 26 days over a period of 6 weeks.
Other Name: 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 Name: Renova-ST Cortical Stimulation System

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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00170716

  Show 21 Study Locations
Sponsors and Collaborators
Northstar Neuroscience
  More Information

Publications:
Responsible Party: VP Clinical Affairs, Northstar Neuroscience
ClinicalTrials.gov Identifier: NCT00170716     History of Changes
Other Study ID Numbers: V0267
Study First Received: September 9, 2005
Last Updated: December 18, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Northstar Neuroscience:
Motor Cortex Electrical Stimulation
Ischemic Stroke
Upper Extremity Hemiparesis
Rehabilitation
Motor Recovery
Functional MRI

Additional relevant MeSH terms:
Cerebral Infarction
Paresis
Stroke
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014