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

Active, not recruiting

Phase 3 Results

Trial Description

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.

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.

Conditions

Interventions

  • Occupational therapy Other
  • Electrical stimulation Other
    Intervention Desc: This category includes any form of electrical stimulation intended to improve motor function or pain after stroke.
  • Rehabilitation Other
    Intervention Desc: Rehabilitation is for 2.5 hrs per day for 26 days over a period of 6 weeks.
    ARM 1: Kind: Experimental
    Label: Control
  • Cortical Stimulation and rehabilitation Device
    Other Names: Renova-ST Cortical Stimulation System
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Investigational

Trial Design

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

Patient Involvement

Active participation in 2 and 1/2 hours of occupational therapy for 26 days; assessments at baseline and 1,4,12 and 24 weeks after completion of therapy regime.

Outcomes

Type Measure Time Frame Safety Issue
Primary Arm Motor Fugl-Meyer Assessment.
Secondary Arm Motor Ability Test, Box and Block, Activities of Daily Living (COPM).
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

Sponsors