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A Neuroprosthesis for Seated Posture and Balance

NCT01474148 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2025-10-27

No results posted yet for this study

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. 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.

Conditions

  • Spinal Cord Injury
  • Paralysis
  • Tetraplegia
  • Paraplegia

Interventions

DEVICE

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

Surgical implantation of the 8-channel neuroprosthesis

Sponsors & Collaborators

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Ronald Triolo, PhD · Louis Stokes VA Medical Center, Cleveland, OH

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2027-01-31
Completion
2027-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01474148 on ClinicalTrials.gov