Evaluation of an Advanced Lower Extremity Neuroprostheses

NCT00623389 | Recruiting DMC FDA Device

• 1 other identifier: EB-001889
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Spinal Cord Injuries; Stroke; Paralysis; Tetraplegia; Paraplegia

Keywords

Neurologic disorders; Rare disease; Spinal cord injuries; Stroke; Paraplegia; Tetraplegia

Outcome Measures

Primary Outcomes (4)

• Device reliability and technical performance measuring changes in standing duration from baseline at discharge to 12 months after discharge

  Repeated measures of standing duration in minutes

  Change from immediately after intervention and 1 year after intervention

• Device reliability and technical performance measuring changes in standing loads from baseline at discharge to 12 months after discharge

  Repeated measures of arm/leg loading measured in Kg

  Change from immediately after intervention and 1 year after intervention

• Device reliability and technical performance measuring changes in walking distance from baseline at discharge to 12 months after discharge

  Repeated measures of walking distance in meters

  Change from immediately after intervention and 1 year after intervention

• Device reliability and technical performance measuring changes in walking duration from baseline at discharge to 12 months after discharge

  Repeated measures of walking time in minutes

  Change from immediately after intervention and 1 year after intervention

Secondary Outcomes (1)

• Device operability measuring changes in functional activities of daily living from baseline at discharge and 12 months after discharge

  Change from immediately after intervention and 1 year after intervention

Study Arms (1)

Implant

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 (Implanted Stimulator-Telemeter)

Interventions

IST (Implanted Stimulator-Telemeter) DEVICE

Pre-surgical exercise with surface electrical stimulation, surgery including electrode and IST- implanted pulse generator insertion, exercise and physical therapy with the implanted system, functional training and laboratory assessment of clinical and technical performance.

Implant

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Skeletal maturity and ability to sign informed consent (\>18 years)
• Non-ventilator dependent paralysis resulting from injuries such as: mid cervical/thoracic (C4 or below) spinal cord injuries, poststroke hemiparesis, TBI, or MS, affecting the trunk and/or lower limbs
• Innervated and excitable lower extremity and trunk musculature
• Adequate social support and stability
• Willingness to comply with follow-up procedures

You may not qualify if:

• Non-English speaking
• Females who are pregnant
• Current pressure injuries that would be exacerbated by study activities
• Severe contractures or uncontrolled spasticity of any major joint of the upper or lower extremities that results in a fixed deformity that would interfere with study activities
• History of spontaneous fractures or other evidence of excessively low bone density
• History of vestibular dysfunction, balance problems, or spontaneous falls
• Acute and or/untreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture.

Sponsors & Collaborators

• Case Western Reserve University: lead

Study Sites (2)

Louis Stokes Cleveland VA Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

MetroHealth System

Cleveland, Ohio, 44109, United States

RECRUITING

Related Publications (8)

• 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;2006:3592-5. doi: 10.1109/IEMBS.2006.260833.

  PMID: 17947042 BACKGROUND

• 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;2006:5408-11. doi: 10.1109/IEMBS.2006.259257.

  PMID: 17946304 BACKGROUND

• 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. doi: 10.1088/1741-2560/4/3/S05. Epub 2007 Aug 22.

  PMID: 17873417 BACKGROUND

• 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. doi: 10.1109/TNSRE.2004.827224.

  PMID: 15218941 BACKGROUND

• 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. doi: 10.1682/jrrd.2003.11.0469.

  PMID: 15077659 BACKGROUND

• 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.

  PMID: 14582528 BACKGROUND

• 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.

  PMID: 11767968 BACKGROUND

• Triolo RJ, Bailey SN, Foglyano KM, Kobetic R, Lombardo LM, Miller ME, Pinault G. Long-Term Performance and User Satisfaction With Implanted Neuroprostheses for Upright Mobility After Paraplegia: 2- to 14-Year Follow-Up. Arch Phys Med Rehabil. 2018 Feb;99(2):289-298. doi: 10.1016/j.apmr.2017.08.470. Epub 2017 Sep 9.

  PMID: 28899825 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Stroke; Paralysis; Quadriplegia; Paraplegia; Nervous System Diseases; Rare Diseases

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Brain Diseases; Vascular Diseases; Cardiovascular Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Ronald J Triolo, Ph.D.

  Case Western Reserve University

  PRINCIPAL INVESTIGATOR

• Musa L Audu, Ph.D.

  Louis Stokes Cleveland VA Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lisa M Lombardo, MPT

CONTACT

216-791-3800; lisa.lombardo2@va.gov

Maura Malenchek, PTA

CONTACT

216-791-3800; maura.malencheck@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Biomedical Engineer

Study Record Dates

• First Submitted: January 24, 2008
• First Posted: February 26, 2008
• Study Start: June 1, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 15, 2025

Record last verified: 2025-06

Locations

US (2)