Evaluation of an Advanced Lower Extremity Neuroprostheses (LE-IST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT00623389
Recruitment Status : Recruiting
First Posted : February 26, 2008
Last Update Posted : January 25, 2018
National Institutes of Health (NIH)
VA Office of Research and Development
Information provided by (Responsible Party):
Ronald J. Triolo, Case Western Reserve University

January 24, 2008
February 26, 2008
January 25, 2018
May 2005
January 2019   (Final data collection date for primary outcome measure)
Standing, walking and balance performance [ Time Frame: Discharge, 6 months and 12 months ]
Same as current
Complete list of historical versions of study NCT00623389 on Archive Site
Standing duration, reachable workspace, and ability to perform other functional activities of daily living [ Time Frame: Discharge, 6 months and 12 months ]
Same as current
Not Provided
Not Provided
Evaluation of an Advanced Lower Extremity Neuroprostheses
Evaluation of Advanced Lower Extremity Neuroprostheses
The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate exercise, standing, stepping and/or balance in people with various degrees of paralysis.

Protocol Outline: Patents undergo surgery in which electrodes are implanted into muscles of the trunk and legs. Electrode leads are connected to an stimulator/telemeter. Following implantation, patients undergo training in standing, transfers and other advanced mobility skills using the functional electrical stimulation system. A prescribed course of exercise, functional training and rehabilitation with the implanted stimulation system, followed by laboratory assessments of strength, balance and functional abilities with and without the system, as well as the technical performance of the implanted components. Home-based training follows prior to discharge for home use of the system.

Patients are followed at 6 and 12 months after discharge and then annually thereafter.

Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Spinal Cord Injuries
  • Stroke
  • Paralysis
  • Tetraplegia
  • Paraplegia
Device: IST-16 (16-channel implanted stimulator-telemeter)
Pre-surgical exercise with surface electrical stimulation, surgery including electrode insertion and IST-16 stimulator/telemeter implantation, exercise and physical therapy with the implanted system, functional training and laboratory assessment of clinical and technical performance.
Experimental: A
Volunteers are evaluated for appropriateness for inclusion in the study on an intent-to-treat basis. Qualifying candidates all receive the implanted neuroprosthesis and participate in post-operative training and follow-up procedures.
Intervention: Device: IST-16 (16-channel implanted stimulator-telemeter)

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
June 2019
January 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Low cervical or thoracic spinal cord injury (C6-T12) or other paralyzing condition
  • Skeletal maturity
  • Ability to understand and sign informed consents
  • Disability equivalent to ASIA impairment scale A (complete motor and sensory deficits), B (sensory sparing) or C (motor and sensory sparing)
  • Intact and electrically excitable lower motor neurons
  • Greater than 6 months since injury or onset
  • Range of motion within normal limits

Exclusion Criteria:

  • Pacemaker
  • Cardiac arrythmia
  • Pregnancy
  • Contractures of any major joint of upper or lower extremities
  • Uncontrolled seizure disorder
  • Obesity
  • Untreated substance abuse
  • Immunodeficiency
  • Frequent urinary tract infections
  • Presence of decubitis ulcers
  • Acute or chronic psychological problems
  • Acute orthopaedic problems
  • Pulmonary compromise
  • Renal compromise
  • Circulatory compromise
  • History of spontaneous fractures or insulin dependent diabetes
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact: Lisa M Lombardo, MPT 216-791-3800 ext 4909
Contact: Tara Byrd, BS 216-791-3800 ext 4864
United States
Not Provided
Not Provided
Ronald J. Triolo, Case Western Reserve University
Case Western Reserve University
  • National Institutes of Health (NIH)
  • VA Office of Research and Development
Principal Investigator: Ronald J Triolo, Ph.D. Case Western Reserve University
Principal Investigator: Musa L Audu, Ph.D. Louis Stokes Cleveland VA Medical Center
Case Western Reserve University
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP