Neuroprosthesis for Seated Posture and Balance in Spinal Cord Injury

This study is testing a surgically implanted device called IRS-8, an 8-channel neuroprosthesis (a device that helps nerves work better), for people with spinal cord injuries. The goal is to see if stimulating trunk and hip muscles with small electrical currents (functional electrical stimulation or FES) can help you sit more stably, breathe better, reach further, and move around more easily in a wheelchair or bed. Researchers will measure these effects over up to 36 months. You might be able to join if you are 21 or older, have a spinal cord injury between C4 and T12, and your injury happened more than 6 months ago. The study plans to enroll 10 participants, but its current recruitment status is unclear.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 10 participants.
What's involved
You would have surgery to implant the IRS-8 device, followed by a 2-5 day hospital stay and 2-6 weeks of restricted activity at home. After this, you would participate in exercise and training, and have laboratory assessments with and without the device.
Compensation
Not stated in the trial record.
Follow-up
The study will evaluate the effects of the device for up to 36 months.

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NCT01474148

A Neuroprosthesis for Seated Posture and Balance

Recruiting
NAAges 21+InterventionalTreatment
VA Office of Research and Development
~10 participants
Updated 2025-10-27 on ClinicalTrials.gov
What's tested:IRS-8 (8-Channel implanted stimulator-telemeter)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effect of Trunk stimulation on control seated posture, respiration, seated interface pressures, reach ability, seated stability & personal mobility.
Measured over up to 36 months
Spinal Cord Injury
Paralysis
Tetraplegia
Paraplegia
1 sites across 1 states
Ohio1
  • Ronald Triolo, PhD · PRINCIPAL_INVESTIGATOR · Louis Stokes VA Medical Center, Cleveland, OH

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
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

Exclusion

Pregnancy
Non-English speaking
  • Effect of Trunk stimulation on control seated posture, respiration, seated interface pressures, reach ability, seated stability & personal mobility.up to 36 months

    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.