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Evaluation of an Advanced Lower Extremity Neuroprostheses (LE-IST)
This study is currently recruiting participants.
Verified by Case Western Reserve University, January 2008
Sponsors and Collaborators: Case Western Reserve University
National Institutes of Health (NIH)
Department of Veterans Affairs
Information provided by: Case Western Reserve University
ClinicalTrials.gov Identifier: NCT00623389
  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

MedlinePlus related topics: Exercise and Physical Fitness Paralysis Spinal Cord Injuries
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Evaluation of Advanced Lower Extremity Neuroprostheses

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: 25
Study Start Date: May 2005
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
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
Pre-surgical exercise with surface electrical stimulation, surgery including electrode insertion and 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: Barbara A Seitz, RN 216-791-3800 ext 4673 bseitz@metrohealth.org
Contact: Lori R Murray, DPT 216-778-3604 lmurray@fes.case.edu

Locations
United States, Ohio
MetroHealth System Recruiting
Cleveland, Ohio, United States, 44109
Contact: Barbara A Seitz, RN     216-791-3800 ext 4673     bseitz@metrohealth.org    
Contact: Lori R Murray, DPT     216-778-3604     lmurray@fes.case.edu    
Principal Investigator: Ronald J Triolo, Ph.D.            
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
  More Information

Publications of Results:
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.

Other Publications:
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: US Department of Veterans Affairs and Case Western Reserve University ( Ronald J. Triolo, Ph.D./ Principal Investigator )
Study ID Numbers: EB-001889, NS-040547
Study First Received: January 24, 2008
Last Updated: February 15, 2008
ClinicalTrials.gov Identifier: NCT00623389  
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

Study placed in the following topic categories:
Cerebral Infarction
Spinal Cord Diseases
Stroke
Vascular Diseases
Paraplegia
Rare Diseases
Wounds and Injuries
Disorders of Environmental Origin
Central Nervous System Diseases
 Quadriplegia
Trauma, Nervous System
Brain Diseases
Cerebrovascular Disorders
Paralysis
Spinal Cord Injuries
Signs and Symptoms
Neurologic Manifestations

Additional relevant MeSH terms:
Nervous System Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009



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