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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
Spinal Cord Injuries
Stroke
Paralysis
Tetraplegia
Paraplegia
Device: IST-16 (16-channel implanted stimulator-telemeter)

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Advanced Lower Extremity Neuroprostheses

Resource links provided by NLM:


Further study details as provided by Case Western Reserve University:

Primary Outcome Measures:
  • Standing, walking and balance performance [ Time Frame: Discharge, 6 months and 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10
Study Start Date: May 2005
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00623389

Contacts
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

Locations
United States, Ohio
MetroHealth System Recruiting
Cleveland, Ohio, United States, 44109
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   
Principal Investigator: Ronald J Triolo, Ph.D.         
Louis Stokes Cleveland VA Medical Center Recruiting
Cleveland, Ohio, United States, 44106
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   
Sponsors and Collaborators
Case Western Reserve University
Investigators
Principal Investigator: Ronald J Triolo, Ph.D. Case Western Reserve University
Principal Investigator: Musa L Audu, Ph.D. Louis Stokes Cleveland VA Medical Center
  More Information

Publications:

Responsible Party: Ronald J. Triolo, Biomedical Engineer, Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00623389     History of Changes
Other Study ID Numbers: EB-001889, NS-040547
Study First Received: January 24, 2008
Last Updated: January 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Case Western Reserve University:
Neurologic disorders
Rare disease
Spinal cord injuries
Stroke
Paraplegia
Tetraplegia

Additional relevant MeSH terms:
Quadriplegia
Spinal Cord Injuries
Paraplegia
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Paralysis
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014