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

Evaluation of Advanced Lower Extremity Neuroprostheses

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.

Study Overview

• Status: Recruiting
• Conditions: Stroke; Paralysis; Spinal Cord Injuries; Tetraplegia; Paraplegia
• Intervention / Treatment: Device: IST (Implanted Stimulator-Telemeter)

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.

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lisa M Lombardo, MPT; Phone Number: 64909 216-791-3800; Email: lisa.lombardo2@va.gov
• Study Contact Backup: Name: Maura Malenchek, PTA; Phone Number: 64989 216-791-3800; Email: maura.malencheck@va.gov

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44109
      • Recruiting
      • MetroHealth System
      • Contact: Lisa M Lombardo, MPT; Phone Number: 64909 216-791-3800; Email: lisa.lombardo2@va.gov
      • Contact: Maura Malenchek, PTA; Phone Number: 64989 216-791-3800; Email: maura.malenchek@va.gov
      • Principal Investigator: Ronald J Triolo, Ph.D.
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • Louis Stokes Cleveland VA Medical Center
      • Contact: Lisa M Lombardo, MPT; Phone Number: 4909 216-791-3800; Email: lisa.lombardo2@va.gov
      • Contact: Maura Malenchek, PTA; Phone Number: 64989 216-791-3800; Email: maura.malenchek@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Phase I Inclusion Criteria

1. Skeletal maturity and ability to sign informed consent (>18 years)
2. 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
3. Innervated and excitable lower extremity and trunk musculature
4. Adequate social support and stability
5. Willingness to comply with follow-up procedures

Phase I Exclusion Criteria

1. Non-English speaking
2. Females who are pregnant
3. Current pressure injuries that would be exacerbated by study activities
4. 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
5. History of spontaneous fractures or other evidence of excessively low bone density
6. History of vestibular dysfunction, balance problems, or spontaneous falls
7. Acute and or/untreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Implant; 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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device operability measuring changes in functional activities of daily living from baseline at discharge and 12 months after discharge	Repeated measures of standing reach in cm, and transfer height in cm	Change from immediately after intervention and 1 year after intervention

Collaborators and Investigators

• Sponsor: Case Western Reserve University
• Collaborators: National Institutes of Health (NIH); US 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

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: January 24, 2008
• First Submitted That Met QC Criteria: February 15, 2008
• First Posted (Estimated): February 26, 2008

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Stroke; Tetraplegia; Paraplegia; Rare disease; Spinal cord injuries; Neurologic disorders
• Additional Relevant MeSH Terms: Neurologic Manifestations; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries; Paralysis; Quadriplegia; Paraplegia
• Other Study ID Numbers: EB-001889; NS-040547

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No