Spinal Cord InjuryNCT01923662
A Neuroprosthesis for Prolonged Standing After SCI Using Multi-Contact Peripheral Nerve Electrodes
A study testing IST-16 (16-Channel implanted stimulator-telemeter in people with Spinal Cord Injury and Paralysis, run by VA Office of Research and Development at 1 site in United States.
Trial summary
The purpose of this study is to improve the performance of neuroprosthesis for standing after SCI by developing and testing new advanced methods that use multiple contact peripheral nerve electrodes to slow the onset of fatigue and increase standing duration. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Spinal Cord Injury, Paralysis, Tetraplegia
- What is being tested?
- IST-16 (16-Channel implanted stimulator-telemeter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2013to 18 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Skeletal maturity (age 21 and above), and ability to sign informed consent
- Paralysis resulting from neurological disorder such as low cervical/thoracic spinal cord injuries (C6-T12)
- Time post injury greater than six months to assure neurological and emotional stability
- Innervated and excitable lower extremity and lumbar trunk musculature
- Absence of acute or chronic psychological problems or chemical dependency
- Range of motion within normal limits, (full extension at the hip and knee, and ability to attain a neutral ankle position)
Show all 11Show fewer
- Controlled spasticity and absence of hip flexion and adduction spasms
- Appropriate body habitus (BMI within normal range)
- Adequate social support and stability
- Willingness to comply with follow-up procedures.
- Full coverage of the acetabulum and minimal knee and ankle laxity
Who cannot join
- History of vestibular dysfunction, balance problems or spontaneous falls.
- Acute orthopaedic problems: severe scoliosis or joint dislocation, severe osteoporosis.
- Acute medical complication: cardiac abnormalities, skin breakdowns, uncontrolled seizures, or immunological, pulmonary/ renal/ circulatory compromise, auto-immune deficiencies, sepsis, active infection, dental caries.
- Diabetes
- Non-English speaking subjects
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
About this study
Official title: Exploiting Selective Recruitment to Prolong Standing After SCI
The purpose of this study is to improve the performance of neuroprosthesis for standing after SCI by developing and testing new advanced methods that use multiple contact peripheral nerve electrodes to slow the onset of fatigue and increase standing duration. The new advanced methods will take advantage of the ability of multiple-contact nerve cuff electrodes to selectively activate portions of a muscle that perform the same action. Alternating activation to multiple muscles (or parts of the same muscle) rather than continuously activation the entire muscle group constantly should allow them to rest and recover from fatiguing contractions. This should allow users to remain upright for longer periods of time to perform activities of daily living, reduce the risk of falls due to fatigue, and increase the potential of receiving the health benefits of standing.
Read the detailed description
Neuroprostheses for standing after SCI currently rely on continuous activation of the hip and knee extensor muscles, which results in rapid fatigue and ultimately compromises elapsed standing time. The primary objective of this study is to improve the performance of neuroprostheses for standing by developing and implementing advanced stimulation paradigms that use multi-contact peripheral nerve electrodes to delay fatigue onset and prolong standing duration. The new stimulation paradigms will take advantage of the ability of multi-contact nerve cuff electrodes to selectively activate independent portions of a muscle, or independent muscles that perform the same action. Such a capability will allow one or more muscles (or parts of the same muscle) to rest while the others continue to contract to keep the knee extended and the user upright. Stimulation waveforms that alternate activation to multiple muscles performing the same function, rather than continuously activate the entire muscle group constantly, should allow muscles to rest and recover from fatiguing contractions.
In addition to these important clinical benefits, the project is also of high impact and significance because the methods to be developed will not be specific to any single electrode technology or stimulation system. Any clinical or therapeutic application that requires a sustained muscular contraction or the production of constant joint torques for prolonged periods of time will benefit from the successful completion of this project.
- Conditions
- Spinal Cord Injury, Paralysis, Tetraplegia, Paraplegia
- Being tested
- IST-16 (16-Channel implanted stimulator-telemeter
- Keywords
- Paraplegia, Tetraplegia, Spinal Cord Injury, FES
- Medical subject headings
- Spinal Cord Injuries, Paralysis, Quadriplegia, Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IST-16 (16-Channel implanted stimulator-telemeterDevice
Surgical implantation of IST-16 stimulator and electrodes to stimulate paralyzed muscles. Subjects will receive exercise and physical therapy with the implanted device. Functional training and laboratory assessments of clinical and technical performance will be conducted.
| Study group | Role | What they receive |
|---|---|---|
| Neuroprosthesis | Experimental | Eligible subjects will receive an implanted device (IRS-8 or IST-16) and surgically implanted electrodes to excite muscles that move paralyzed muscles. These electrodes are connected to the implanted stimulator that delivers electrical pulses to the nerves. These pulses cause the muscles to contract to perform functional movements or to exercise. Receives: Device: IST-16 (16-Channel implanted stimulator-telemeter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Standing Performance in Terms of Elapsed Standing Time for All Subjects.
The investigators will assess standing performance in terms of elapsed standing time. The investigators will also collect data related to subjective impression of stability.
Measured: 12 months post-rehabilitation
Secondary outcomes (1)
Percentage of Body Weight Distribution on the Legs While Standing With Stimulation.
Determine the amount of weight on both legs during standing with stimulation.
Measured: 12 months post-rehabilitation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2013 (estimated)
- Study start11 Apr 2013
- Primary completion18 Mar 2024
- Study completion18 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Ronald Triolo, PhD, Principal investigator, Louis Stokes VA Medical Center, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923662
- Sponsor's protocol ID
- B1039-R
- Status last verified
- Aug 2025
- First submitted
- 7 Aug 2013
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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 11767968Davis JA Jr, Triolo RJ, Uhlir JP, Bhadra N, Lissy DA, Nandurkar S, Marsolais EB. Surgical technique for installing an eight-channel neuroprosthesis for standing. Clin Orthop Relat Res. 2001 Apr;(385):237-52. doi: 10.1097/00003086-200104000-00035.
PubMed 11302320Fisher LE, Tyler DJ, Anderson JS, Triolo RJ. Chronic stability and selectivity of four-contact spiral nerve-cuff electrodes in stimulating the human femoral nerve. J Neural Eng. 2009 Aug;6(4):046010. doi: 10.1088/1741-2560/6/4/046010. Epub 2009 Jul 15.
PubMed 19602729Fisher LE, Miller ME, Bailey SN, Davis JA Jr, Anderson JS, Rhode L, Tyler DJ, Triolo RJ. Standing after spinal cord injury with four-contact nerve-cuff electrodes for quadriceps stimulation. IEEE Trans Neural Syst Rehabil Eng. 2008 Oct;16(5):473-8. doi: 10.1109/TNSRE.2008.2003390.
PubMed 18990650Uhlir JP, Triolo RJ, Kobetic R. The use of selective electrical stimulation of the quadriceps to improve standing function in paraplegia. IEEE Trans Rehabil Eng. 2000 Dec;8(4):514-22. doi: 10.1109/86.895955.
PubMed 11204043Chae J, Kilgore K, Triolo R, Creasey G. Functional neuromuscular stimulation in spinal cord injury. Phys Med Rehabil Clin N Am. 2000 Feb;11(1):209-26, x.
PubMed 10680166Freeberg MJ, Pinault GCJ, Tyler DJ, Triolo RJ, Ansari R. Chronic nerve health following implantation of femoral nerve cuff electrodes. J Neuroeng Rehabil. 2020 Jul 14;17(1):95. doi: 10.1186/s12984-020-00720-3.
PubMed 32664972
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploiting Selective Recruitment to Prolong Standing After SCI
- ClinicalTrials.gov ID
- NCT01923662
- Acronym / sponsor ID
- B1039-R
- Conditions
- Spinal Cord Injury, Paralysis, Tetraplegia, Paraplegia
- Keywords
- Paraplegia, Tetraplegia, Spinal Cord Injury, FES
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- National Institutes of Health (NIH)
- Study start
- 11 Apr 2013 (actual)
- Primary completion
- 18 Mar 2024 (actual)
- Study completion
- 18 Mar 2024 (actual)
- First posted
- 15 Aug 2013 (estimated)
- Results
- Posted 22 Aug 2025
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 improve the performance of neuroprosthesis for standing after SCI by developing and testing new advanced methods that use multiple contact peripheral nerve electrodes to slow the onset of fatigue and increase standing duration. The new advanced methods will take advantage of the ability of multiple-contact nerve cuff electrodes to selectively activate portions of a muscle that perform the same action. Alternating activation to multiple muscles (or parts of the same muscle) rather than continuously activation the entire muscle group constantly should allow them to rest and recover from fatiguing contractions. This should allow users to remain upright for longer periods of time to perform activities of daily living, reduce the risk of falls due to fatigue, and increase the potential of receiving the health benefits of standing.
Detailed description
Neuroprostheses for standing after SCI currently rely on continuous activation of the hip and knee extensor muscles, which results in rapid fatigue and ultimately compromises elapsed standing time. The primary objective of this study is to improve the performance of neuroprostheses for standing by developing and implementing advanced stimulation paradigms that use multi-contact peripheral nerve electrodes to delay fatigue onset and prolong standing duration. The new stimulation paradigms will take advantage of the ability of multi-contact nerve cuff electrodes to selectively activate independent portions of a muscle, or independent muscles that perform the same action. Such a capability will allow one or more muscles (or parts of the same muscle) to rest while the others continue to contract to keep the knee extended and the user upright. Stimulation waveforms that alternate activation to multiple muscles performing the same function, rather than continuously activate the entire muscle group constantly, should allow muscles to rest and recover from fatiguing contractions.
In addition to these important clinical benefits, the project is also of high impact and significance because the methods to be developed will not be specific to any single electrode technology or stimulation system. Any clinical or therapeutic application that requires a sustained muscular contraction or the production of constant joint torques for prolonged periods of time will benefit from the successful completion of this project.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neuroprosthesis | Experimental | Device: IST-16 (16-Channel implanted stimulator-telemeterEligible subjects will receive an implanted device (IRS-8 or IST-16) and surgically implanted electrodes to excite muscles that move paralyzed muscles. These electrodes are connected to the implanted stimulator that delivers electrical pulses to the nerves. These pulses cause the muscles to contract to perform functional movements or to exercise. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Skeletal maturity (age 21 and above), and ability to sign informed consent
- Paralysis resulting from neurological disorder such as low cervical/thoracic spinal cord injuries (C6-T12)
- Time post injury greater than six months to assure neurological and emotional stability
- Innervated and excitable lower extremity and lumbar trunk musculature
- Absence of acute or chronic psychological problems or chemical dependency
Key exclusion criteria (6 listed)
- History of vestibular dysfunction, balance problems or spontaneous falls.
- Acute orthopaedic problems: severe scoliosis or joint dislocation, severe osteoporosis.
- Acute medical complication: cardiac abnormalities, skin breakdowns, uncontrolled seizures, or immunological, pulmonary/ renal/ circulatory compromise, auto-immune deficiencies, sepsis, active infection, dental caries.
- Diabetes
- Non-English speaking subjects
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-16 (16-Channel implanted stimulator-telemeterSurgical implantation of IST-16 stimulator and electrodes to stimulate paralyzed muscles. Subjects will receive exercise and physical therapy with the implanted device. Functional training and laboratory assessments of clinical and technical performance will be conducted. | Device | Neuroprosthesis |
Primary outcome
Average Standing Performance in Terms of Elapsed Standing Time for All Subjects.
Time frame: 12 months post-rehabilitation
The investigators will assess standing performance in terms of elapsed standing time. The investigators will also collect data related to subjective impression of stability.
1 secondary outcome
Percentage of Body Weight Distribution on the Legs While Standing With Stimulation.
Time frame: 12 months post-rehabilitation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
- Background: PubMed 11302320Davis JA Jr, Triolo RJ, Uhlir JP, Bhadra N, Lissy DA, Nandurkar S, Marsolais EB. Surgical technique for installing an eight-channel neuroprosthesis for standing. Clin Orthop Relat Res. 2001 Apr;(385):237-52. doi: 10.1097/00003086-200104000-00035.
- Background: PubMed 19602729Fisher LE, Tyler DJ, Anderson JS, Triolo RJ. Chronic stability and selectivity of four-contact spiral nerve-cuff electrodes in stimulating the human femoral nerve. J Neural Eng. 2009 Aug;6(4):046010. doi: 10.1088/1741-2560/6/4/046010. Epub 2009 Jul 15.
- Background: PubMed 18990650Fisher LE, Miller ME, Bailey SN, Davis JA Jr, Anderson JS, Rhode L, Tyler DJ, Triolo RJ. Standing after spinal cord injury with four-contact nerve-cuff electrodes for quadriceps stimulation. IEEE Trans Neural Syst Rehabil Eng. 2008 Oct;16(5):473-8. doi: 10.1109/TNSRE.2008.2003390.
- Background: PubMed 11204043Uhlir JP, Triolo RJ, Kobetic R. The use of selective electrical stimulation of the quadriceps to improve standing function in paraplegia. IEEE Trans Rehabil Eng. 2000 Dec;8(4):514-22. doi: 10.1109/86.895955.
- Background: PubMed 10680166Chae J, Kilgore K, Triolo R, Creasey G. Functional neuromuscular stimulation in spinal cord injury. Phys Med Rehabil Clin N Am. 2000 Feb;11(1):209-26, x.
- Derived from this study: PubMed 32664972Freeberg MJ, Pinault GCJ, Tyler DJ, Triolo RJ, Ansari R. Chronic nerve health following implantation of femoral nerve cuff electrodes. J Neuroeng Rehabil. 2020 Jul 14;17(1):95. doi: 10.1186/s12984-020-00720-3.
- APT Center is a VA Center of ExcellenceLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Ronald Triolo, PhD principal investigator
Louis Stokes VA Medical Center, Cleveland, OH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IST-16 (16-Channel implanted stimulator-telemeter in people with Spinal Cord Injury and Paralysis, run by VA Office of Research and Development at 1 site 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?
The sponsor lists 11 inclusion and 6 exclusion criteria. 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: finished, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 22 Aug 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average Standing Performance in Terms of Elapsed Standing Time for All Subjects. (time frame: 12 months post-rehabilitation). 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 NCT01923662, which also lists 7 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 22 Aug 2025.