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

This study is currently recruiting participants.
Verified January 2014 by Case Western Reserve University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Ronald J. Triolo, Case Western Reserve University
ClinicalTrials.gov Identifier:
NCT00623389
First received: January 24, 2008
Last updated: January 28, 2014
Last verified: January 2014

January 24, 2008
January 28, 2014
May 2005
January 2015   (final data collection date for primary outcome measure)
Standing, walking and balance performance [ Time Frame: Discharge, 6 months and 12 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00623389 on ClinicalTrials.gov Archive Site
Standing duration, reachable workspace, and ability to perform other functional activities of daily living [ Time Frame: Discharge, 6 months and 12 months ] [ Designated as safety issue: No ]
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.

Interventional
Not Provided
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
10
June 2015
January 2015   (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
Both
18 Years and older
No
Contact: Lisa M Lombardo, MPT 216-791-3800 ext 4909 llombardo@fescenter.org
Contact: Marilyn MCCormick, RN 216-791-3800 ext 4236 marilyn.mccormick@va.gov
United States
 
NCT00623389
EB-001889, NS-040547
Yes
Ronald J. Triolo, Case Western Reserve University
Case Western Reserve University
  • National Institutes of Health (NIH)
  • Department of Veterans Affairs
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 2014

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