Neuroprosthesis for Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

Overseen byRonald Triolo, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: VA Office of Research and Development

No Placebo Group

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this study is to improve the performance of neuroprosthesis for standing after SCI by developing and testing new advanced methods that use multiple contact peripheral nerve electrodes to slow the onset of fatigue and increase standing duration. The new advanced methods will take advantage of the ability of multiple-contact nerve cuff electrodes to selectively activate portions of a muscle that perform the same action. Alternating activation to multiple muscles (or parts of the same muscle) rather than continuously activation the entire muscle group constantly should allow them to rest and recover from fatiguing contractions. This should allow users to remain upright for longer periods of time to perform activities of daily living, reduce the risk of falls due to fatigue, and increase the potential of receiving the health benefits of standing.

Research Team

Ronald Triolo, PhD

Principal Investigator

Louis Stokes VA Medical Center, Cleveland, OH

Eligibility Criteria

This trial is for adults over 21 with stable spinal cord injuries (C6-T12) causing paralysis, who have muscle control in their lower body and trunk. They must be able to consent, not have psychological issues or chemical dependency, and commit to follow-up procedures. Excluded are non-English speakers, pregnant individuals, those with diabetes or balance disorders, severe bone/joint problems, major medical complications like heart issues or infections.

Inclusion Criteria

My muscle stiffness is under control and I don't have spasms in my hip.

It has been over 6 months since my injury.

My body mass index (BMI) is within the normal range.

See 8 more

Exclusion Criteria

I have had issues with balance or unexpected falls.

I have severe bone issues like very curved spine or weak bones.

I do not speak English.

See 3 more

Treatment Details

Interventions

IST-16 (Neuroprosthetics)

Trial OverviewThe study tests a device called IST-16 designed to help people with spinal cord injuries stand longer by stimulating nerves in the legs and lower back. It alternates muscle activation using multiple-contact nerve electrodes to reduce fatigue during standing tasks.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: NeuroprosthesisExperimental Treatment1 Intervention

Eligible subjects will receive an implanted device (IRS-8 or IST-16) and surgically implanted electrodes to excite muscles that move paralyzed muscles. These electrodes are connected to the implanted stimulator that delivers electrical pulses to the nerves. These pulses cause the muscles to contract to perform functional movements or to exercise.