Spinal Cord InjuriesLE-ISTNCT00623389
Evaluation of an Advanced Lower Extremity Neuroprostheses
A study testing IST (Implanted Stimulator-Telemeter) in people with Spinal Cord Injuries and Stroke, run by Case Western Reserve University at 2 sites in United States.
Trial 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 more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Spinal Cord Injuries, Stroke, Paralysis
- What is being tested?
- IST (Implanted Stimulator-Telemeter)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jun 2018to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Phase I Inclusion Criteria
- 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
Phase I Exclusion Criteria
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Louis Stokes Cleveland VA Medical Center
Cleveland, Ohio, 44106
Lisa M Lombardo, MPT, 216-791-3800 ext. 4909, lisa.lombardo2@va.gov
Maura Malenchek, PTA, 216-791-3800 ext. 64989, maura.malenchek@va.gov
- Recruiting
MetroHealth System
Cleveland, Ohio, 44109
Lisa M Lombardo, MPT, 216-791-3800 ext. 64909, lisa.lombardo2@va.gov
Maura Malenchek, PTA, 216-791-3800 ext. 64989, maura.malenchek@va.gov
About this study
Official title: 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.
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.
- Conditions
- Spinal Cord Injuries, Stroke, Paralysis, Tetraplegia, Paraplegia
- Being tested
- IST (Implanted Stimulator-Telemeter)
- Keywords
- Neurologic disorders, Rare disease, Spinal cord injuries, Stroke, Paraplegia, Tetraplegia
- Medical subject headings
- Spinal Cord Injuries, Stroke, Paralysis, Quadriplegia, Paraplegia, Nervous System Diseases, Rare Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: IST (Implanted Stimulator-Telemeter) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Change from immediately after intervention and 1 year after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2008 (estimated)
- Study start1 Jun 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Case Western Reserve University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ronald J. Triolo, Case Western Reserve University
- Investigators
- Ronald J Triolo, Ph.D., Principal investigator, Case Western Reserve UniversityMusa L Audu, Ph.D., Principal investigator, Louis Stokes Cleveland VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00623389
- Sponsor's protocol ID
- EB-001889
- Acronym
- LE-IST
- Status last verified
- Jul 2026
- First submitted
- 24 Jan 2008
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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 17946304Uhlir 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 15218941Bogie 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 15077659Agarwal 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 14582528Davis 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 11767968Fisher 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 17947042Mushahwar 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 17873417Triolo 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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Advanced Lower Extremity Neuroprostheses
- ClinicalTrials.gov ID
- NCT00623389
- Acronym / sponsor ID
- LE-IST / EB-001889
- Conditions
- Spinal Cord Injuries, Stroke, Paralysis, Tetraplegia, Paraplegia
- Keywords
- Neurologic disorders, Rare disease, Spinal cord injuries, Stroke, Paraplegia, Tetraplegia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Case Western Reserve UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 26 Feb 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant | Experimental | Device: IST (Implanted Stimulator-Telemeter)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. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Implant |
Primary outcome
Device reliability and technical performance measuring changes in standing duration from baseline at discharge to 12 months after discharge
Time frame: Change from immediately after intervention and 1 year after intervention
Repeated measures of standing duration in minutes
Device reliability and technical performance measuring changes in standing loads from baseline at discharge to 12 months after discharge
Time frame: Change from immediately after intervention and 1 year after intervention
Repeated measures of arm/leg loading measured in Kg
Device reliability and technical performance measuring changes in walking distance from baseline at discharge to 12 months after discharge
Time frame: Change from immediately after intervention and 1 year after intervention
Repeated measures of walking distance in meters
Device reliability and technical performance measuring changes in walking duration from baseline at discharge to 12 months after discharge
Time frame: Change from immediately after intervention and 1 year after intervention
Repeated measures of walking time in minutes
1 secondary outcome
Device operability measuring changes in functional activities of daily living from baseline at discharge and 12 months after discharge
Time frame: Change from immediately after intervention and 1 year after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Background: PubMed 17946304Dutta 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.
- Background: PubMed 15218941Uhlir 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.
- Background: PubMed 15077659Bogie 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.
- Background: PubMed 14582528Agarwal 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.
- Background: PubMed 11767968Davis 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.
- Results publication: PubMed 17947042Fisher 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.
- Results publication: PubMed 17873417Mushahwar 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.
- Derived from this study: PubMed 28899825Triolo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ronald J Triolo, Ph.D. principal investigator
Case Western Reserve University
Musa L Audu, Ph.D. principal investigator
Louis Stokes Cleveland VA Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IST (Implanted Stimulator-Telemeter) in people with Spinal Cord Injuries and Stroke, run by Case Western Reserve University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa M Lombardo, MPT (216-791-3800 ext. 64909, lisa.lombardo2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device reliability and technical performance measuring changes in standing duration from baseline at discharge to 12 months after discharge (time frame: Change from immediately after intervention and 1 year after intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00623389, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2026.