NCT01474148

A Neuroprosthesis for Seated Posture and Balance

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Spinal Cord Injury
• Paralysis
• Tetraplegia
• Paraplegia

Interventions

Type	Name	Description
DEVICE	IRS-8 (8-Channel implanted stimulator-telemeter)	Surgical implantation of the 8-channel neuroprosthesis

Timeline

• Start date: 2011-11-30
• Primary completion: 2027-01-31
• Completion: 2027-01-31
• First posted: 2011-11-18
• Last updated: 2025-10-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study