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NCT Number: NCT01474148

A Neuroprosthesis for Seated Posture and Balance

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

Location status: Recruiting

Location contact

Lisa M Lombardo, MPT

CONTACT

[email protected]

(216) 791-3800 ext. 4909

Ronald Triolo, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • Pregnancy
  • Non-English speaking

Treatment and study plan

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

Device

Surgical implantation of the 8-channel neuroprosthesis

Other names: Implanted Neuroprosthesis for Seated Posture and Balance, Trunk implanted electrical stimulation system, Implanted trunk control neuroprosthesis, Implanted FNS

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. Design a simple position controller

    Time frame: Up to 36 months

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Emily C Johnson, BA

CONTACT

[email protected]

(216) 791-3800 ext. 64904

Lisa M Lombardo, MPT

CONTACT

[email protected]

(216) 791-3800 ext. 4909

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Acronym: Trunk Protocol

Important dates

Study start
2011
Primary completion
2027
Study completion
2027
First posted
Nov 18, 2011
Registry last updated
Oct 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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