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Electrical Stimulation

Neuroprosthesis for Spinal Cord Injury (Trunk Protocol Trial)

Cleveland, OH

N/A

Recruiting

Led By Ronald Triolo, PhD

Research Sponsored by VA Office of Research and Development

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Controlled spasticity and absence of hip flexion and adduction spasm

C4-T12

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 36 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new way to help people with spinal cord injuries move their bodies using electrical stimulation.

Who is the study for?

This trial is for English-speaking adults with spinal cord injuries (quadriplegia or paraplegia) between C4-T12, ASIA Scale A-C. They should be stable post-injury (>6 months), without severe bone density issues, orthopedic problems, medical complications, psychological issues, or substance abuse. Participants need normal range of motion and body size and must not be pregnant.

What is being tested?

The study tests an implanted device called IRS-8 that uses electrical currents to help stabilize the trunk and hips in people with spinal cord injuries. It aims to improve their ability to sit up straight, breathe easier, reach out, push a wheelchair more effectively, and roll over in bed.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, skin irritation from electrodes used during FES therapy sessions. There might also be muscle fatigue due to stimulated contractions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My muscle stiffness is under control and I don't have spasms that pull my hip up or inward.

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My spinal injury is between the C4 and T12 vertebrae.

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I can move all my joints normally.

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I have not had issues with balance or unexpected falls.

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I have never had a bone break on its own or been told I have low bone density.

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I currently have no severe health issues.

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My spinal cord injury level is between complete and moderate.

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My height and weight are within the normal range.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 36 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 36 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 36 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Design a simple position controller

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: NeuroprosthesisExperimental Treatment1 Intervention

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.

0 / 8Eligibility criteria met