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RecruitingNCT00623389LE-ISTUpdated Jul 10, 2026

Evaluation of an Advanced Lower Extremity Neuroprostheses

An interventional study of IST (Implanted Stimulator-Telemeter) in Spinal Cord Injuries, Stroke and Paralysis, sponsored by Case Western Reserve University. Recruiting at 2 sites in United States. Open to participants aged 21 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-07-10.

Sponsored by Case Western Reserve University · Not applicable, Interventional, and Device feasibility

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
21 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Spinal Cord Injuries
  • Stroke
  • Paralysis
  • Tetraplegia
  • Paraplegia

Keywords

  • Neurologic disorders
  • Rare disease
  • Spinal cord injuries
  • Stroke
  • Paraplegia
  • Tetraplegia
03

Who can participate

Ages eligible
21 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • 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)

Interventions

  • DeviceIST (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.

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: Change from immediately after intervention and 1 year after intervention

  2. 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

    Time frame: Change from immediately after intervention and 1 year after intervention

  3. 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

    Time frame: Change from immediately after intervention and 1 year after intervention

  4. 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

    Time frame: 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

    Repeated measures of standing reach in cm, and transfer height in cm

    Time frame: Change from immediately after intervention and 1 year after intervention

06

Study locations

2 of 2 sites recruiting
  • Louis Stokes Cleveland VA Medical Center
    Cleveland, Ohio 44106, United States
    Recruiting
  • MetroHealth System
    Cleveland, Ohio 44109, United States
    Recruiting
07

References and documents

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;2006:5408-11. doi: 10.1109/IEMBS.2006.259257. PubMed 17946304 ↗
  • 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. PubMed 15218941 ↗
  • 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. PubMed 15077659 ↗
  • 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. PubMed 14582528 ↗
  • 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. PubMed 11767968 ↗
  • 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. PubMed 17947042 ↗
  • 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. PubMed 17873417 ↗
  • 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. PubMed 28899825 ↗
08

Registry details

Key details

Study ID
NCT00623389
Lead sponsor
Case Western Reserve University
Responsible party
Ronald J. Triolo (Biomedical Engineer, Case Western Reserve University) — Principal investigator
First posted
Feb 26, 2008
Start date
Jun 1, 2018
Primary completion
Dec 31, 2027 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Jul 10, 2026

Study contacts

Lisa M Lombardo, MPT
Contact
lisa.lombardo2@va.gov
216-791-3800 ext. 64909
Maura Malenchek, PTA
Contact
maura.malencheck@va.gov
216-791-3800 ext. 64989
Ronald J Triolo, Ph.D.
principal investigator · Case Western Reserve University
Musa L Audu, Ph.D.
principal investigator · Louis Stokes Cleveland VA Medical Center

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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