A Neuroprosthesis for Seated Posture and Balance (Trunk Protocol)

VA Office of Research and Development

Status: Enrolling

Conditions: Tetraplegia; Spinal Cord Injury; Paraplegia; Paralysis

Treatments: Device: IRS-8 (8-Channel implanted stimulator-telemeter)

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01474148

A1204-R

IRB#07101-H36 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Neuroprosthesis

Experimental group

Description:

Volunteers 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.

Treatment:

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