We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study is currently recruiting participants.
Verified July 2017 by Ronald J. Triolo, Case Western Reserve University
Sponsor:
ClinicalTrials.gov Identifier:
NCT00623389
First Posted: February 26, 2008
Last Update Posted: July 19, 2017
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.
Collaborators:
National Institutes of Health (NIH)
VA Office of Research and Development
Information provided by (Responsible Party):
Ronald J. Triolo, Case Western Reserve University
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Advanced Lower Extremity Neuroprostheses

Resource links provided by NLM:


Further study details as provided by Ronald J. Triolo, Case Western Reserve University:

Primary Outcome Measures:
  • Standing, walking and balance performance [ Time Frame: Discharge, 6 months and 12 months ]

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 ]

Estimated Enrollment: 10
Study Start Date: May 2005
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: January 2019 (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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00623389


Contacts
Contact: Lisa M Lombardo, MPT 216-791-3800 ext 4909 llombardo@fescenter.org
Contact: Jacinta M Seton, RN 216-791-3800 ext 4236 jseton@aptcenter.org

Locations
United States, Ohio
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: Jacinta M Seton, RN    216-791-3800 ext 4236    jseton@aptcenter.org   
MetroHealth System Recruiting
Cleveland, Ohio, United States, 44109
Contact: Lisa M Lombardo, MPT    216-791-3800 ext 4909    llombardo@fescenter.org   
Contact: Jacinta M Seton, RN    216-791-3800 ext 4236    jseton@aptcenter.org   
Principal Investigator: Ronald J Triolo, Ph.D.         
Sponsors and Collaborators
Case Western Reserve University
National Institutes of Health (NIH)
VA Office of Research and Development
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
First Submitted: January 24, 2008
First Posted: February 26, 2008
Last Update Posted: July 19, 2017
Last Verified: July 2017

Keywords provided by Ronald J. Triolo, Case Western Reserve University:
Neurologic disorders
Rare disease
Spinal cord injuries
Stroke
Paraplegia
Tetraplegia

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