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

This study is currently recruiting participants.

Verified April 2013 by Case Western Reserve University

Sponsor:

Collaborators:

National Institutes of Health (NIH)

Department of Veterans Affairs

Information provided by (Responsible Party):

Ronald J. Triolo, Case Western Reserve University

ClinicalTrials.gov Identifier:

NCT00623389

First received: January 24, 2008

Last updated: April 29, 2013

Last verified: April 2013

History of Changes

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:

MedlinePlus related topics: Paralysis Spinal Cord Injuries

U.S. FDA Resources

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

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: Jean Marlow, RN	216-791-3800 ext 4236	jmarlow@fescenter.org

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: Jean Marlow, RN 216-791-3800 ext 4236 jmarlow@fescenter.org
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: Jean Marlow, RN 216-791-3800 ext 4236 jmarlow@fescenter.org

Sponsors and Collaborators

Case Western Reserve University

National Institutes of Health (NIH)

Department of Veterans Affairs

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:

Fisher LE, Miller ME, Nogan SJ, Davis JA, Anderson JS, Murray LM, Tyler DJ, Triolo RJ. Preliminary evaluation of a neural prosthesis for standing after spinal cord injury with four contact nerve-cuff electrodes for quadriceps stimulation. Conf Proc IEEE Eng Med Biol Soc. 2006;1:3592-5.

Mushahwar VK, Jacobs PL, Normann RA, Triolo RJ, Kleitman N. New functional electrical stimulation approaches to standing and walking. J Neural Eng. 2007 Sep;4(3):S181-97. Epub 2007 Aug 22.

Dutta A, Kobetic R, Triolo RJ. Ambulation after incomplete spinal cord injury with electromyogram-triggered functional electrical stimulation. Conf Proc IEEE Eng Med Biol Soc. 2006;1:5408-11.

Uhlir JP, Triolo RJ, Davis JA Jr, Bieri C. Performance of epimysial stimulating electrodes in the lower extremities of individuals with spinal cord injury. IEEE Trans Neural Syst Rehabil Eng. 2004 Jun;12(2):279-87.

Bogie KM, Triolo RJ. Effects of regular use of neuromuscular electrical stimulation on tissue health. J Rehabil Res Dev. 2003 Nov-Dec;40(6):469-75.

Agarwal S, Triolo RJ, Kobetic R, Miller M, Bieri C, Kukke S, Rohde L, Davis JA Jr. Long-term user perceptions of an implanted neuroprosthesis for exercise, standing, and transfers after spinal cord injury. J Rehabil Res Dev. 2003 May-Jun;40(3):241-52.

Davis JA Jr, Triolo RJ, Uhlir J, Bieri C, Rohde L, Lissy D, Kukke S. Preliminary performance of a surgically implanted neuroprosthesis for standing and transfers--where do we stand? J Rehabil Res Dev. 2001 Nov-Dec;38(6):609-17.

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:	April 29, 2013
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
Paraplegia
Spinal Cord Injuries
Stroke
Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

Spinal Cord Diseases
Central Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Cerebrovascular Disorders
Brain Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013

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