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Spinal Cord InjuryTrunk ProtocolNCT01474148

A Neuroprosthesis for Seated Posture and Balance

A study testing IRS-8 (8-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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. 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?
IRS-8 (8-Channel 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
1 siteUnited States
Study dates
30 Nov 2011to 31 Jan 2028
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • C4-T12
  • ASIA Scale A through C
  • Time post injury greater than 6 months
  • Innervated and excitable trunk and pelvis musculature
  • Absence of acute or chronic psychological problems or chemical dependency
  • Range of motion within normal limits
Show all 14Show fewer
  • Controlled spasticity and absence of hip flexion and adduction spasm
  • Height and weight within normal limits
  • No history of balance problems or spontaneous falls
  • No history of spontaneous fracture or evidence low bone density
  • No acute orthopaedic problems
  • No acute medical complications
  • Adequate social support and stability
  • Able to speak and read English

Who cannot join

  • Pregnancy
  • Non-English speaking

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lisa M Lombardo, MPT contact

(216) 791-3800 ext. 4909

Lisa.Lombardo2@va.gov

Emily C Johnson, BA contact

(216) 791-3800 ext. 64904

emily.johnson17@va.gov

United States1 site, 1 recruiting

  • Louis Stokes VA Medical Center, Cleveland, OH

    Cleveland, Ohio, 44106-1702

    Lisa M Lombardo, MPT, (216) 791-3800 ext. 4909, Lisa.Lombardo2@va.gov

    Ronald Triolo, PhD

    Recruiting

Other trials in United States

About this study

The purpose of this study is to evaluate a surgically implanted functional electrical stimulation (FES) system to facilitate stability of the trunk and hips. FES involves applying small electric currents to the nerves, which cause the muscles to contract. This study evaluates how stabilizing and stiffening the trunk with FES can change the way spinal cord injured volunteers sit, breathe, reach, push a wheelchair, or roll in bed.

Read the detailed description

In a single surgical procedure electrodes will be inserted into muscles of the trunk and hip musculature. The electrode leads are connected to a stimulator/telemeter located in the abdomen. After a typical post-operative period of two to five days, neuroprosthesis recipients will be discharged to home for two to six weeks of restricted activity to promote healing of all surgical incisions. After a period of exercise and training, functional use of the neuroprosthesis will begin. Laboratory assessments of strength, balance, and functional abilities with and without the system, as well as the technical performance of the implanted components will be evaluated.

Being tested
IRS-8 (8-Channel implanted stimulator-telemeter)
Keywords
paraplegia, tetraplegia, Spinal cord injured, 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.

  • IRS-8 (8-Channel implanted stimulator-telemeter)Device

    Also called Implanted Neuroprosthesis for Seated Posture and Balance, Trunk implanted electrical stimulation system, Implanted trunk control neuroprosthesis, Implanted FNS

    Surgical implantation of the 8-channel neuroprosthesis

Study groups in NCT01474148
Study groupRoleWhat they receive
NeuroprosthesisExperimentalVolunteers 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: IRS-8 (8-Channel implanted stimulator-telemeter)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of Trunk stimulation on control seated posture, respiration, seated interface pressures, reach ability, seated stability & personal mobility.

    Experiments involving the effects of trunk stimulation on postural alignment; trunk stability and posture on respiration, postural variation on seated interface pressures; effects of trunk stimulation on reaching ability; effects of trunk stimulation on seated stability, and personal mobility.

    Measured: up to 36 months

Secondary outcomes (1)

  1. Design a simple position controller

    The position controller will be developed to keep the trunk posture at a neutral seated position while allowing movement to lean forward, backward, or side-to-side. Testing will be carried out with an automated pull system applied to the trunk which pulls the body in various ways (side-to-side, forward, backward)

    Measured: Up to 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2011 (estimated)
  2. Study start30 Nov 2011
  3. Primary completion31 Jan 2028 (estimated)
  4. Study completion31 Jan 2028 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
10 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01474148
Sponsor's protocol ID
A1204-R
Other IDs
5I01RX001204-04, IRB#07101-H36
Acronym
Trunk Protocol
Status last verified
Oct 2026
First submitted
8 Nov 2011
Last updated
26 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Triolo RJ, Boggs L, Miller ME, Nemunaitis G, Nagy J, Bailey SN. Implanted electrical stimulation of the trunk for seated postural stability and function after cervical spinal cord injury: a single case study. Arch Phys Med Rehabil. 2009 Feb;90(2):340-7. doi: 10.1016/j.apmr.2008.07.029.

    PubMed 19236990

  • 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

  • Foglyano KM, Lombardo LM, Schnellenberger JR, Triolo RJ. Sudden stop detection and automatic seating support with neural stimulation during manual wheelchair propulsion. J Spinal Cord Med. 2022 Mar;45(2):204-213. doi: 10.1080/10790268.2020.1800278. Epub 2020 Aug 14.

    PubMed 32795162

  • Armstrong KL, Lombardo LM, Foglyano KM, Audu ML, Triolo RJ. Automatic application of neural stimulation during wheelchair propulsion after SCI enhances recovery of upright sitting from destabilizing events. J Neuroeng Rehabil. 2018 Mar 12;15(1):17. doi: 10.1186/s12984-018-0362-2.

    PubMed 29530053

  • 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

  • Wu GA, Lombardo L, Triolo RJ, Bogie KM. The effects of combined trunk and gluteal neuromuscular electrical stimulation on posture and tissue health in spinal cord injury. PM R. 2013 Aug;5(8):688-96. doi: 10.1016/j.pmrj.2013.03.025. Epub 2013 Mar 28.

    PubMed 23542776

  • Triolo RJ, Bailey SN, Miller ME, Lombardo LM, Audu ML. Effects of stimulating hip and trunk muscles on seated stability, posture, and reach after spinal cord injury. Arch Phys Med Rehabil. 2013 Sep;94(9):1766-75. doi: 10.1016/j.apmr.2013.02.023. Epub 2013 Mar 13.

    PubMed 23500182

Questions about this trial

What is this clinical trial studying?

A study testing IRS-8 (8-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 14 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. 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?

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. 4909, Lisa.Lombardo2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of Trunk stimulation on control seated posture, respiration, seated interface pressures, reach ability, seated stability & personal mobility. (time frame: up to 36 months). 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 NCT01474148, 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 26 Oct 2026.

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