← Back to Search

Neuroprosthetics

Neuroprosthesis for Paralysis (LE-IST Trial)

N/A

Recruiting

Led By Ronald J Triolo, Ph.D.

Research Sponsored by Case Western Reserve University

Eligibility Criteria Checklist

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

Must have

Range of motion within normal limits

Disability equivalent to ASIA impairment scale A (complete motor and sensory deficits), B (sensory sparing) or C (motor and sensory sparing)

Must not have

Uncontrolled seizure disorder

Obesity

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from immediately after intervention and 1 year after intervention

Awards & highlights

No Placebo-Only Group

Summary

This trial will test a surgically-implanted device that sends electrical signals to the muscles, to help people with paralysis exercise, stand, and/or maintain balance.

Who is the study for?

This trial is for adults with paralysis due to spinal cord injury or conditions like stroke, who've been affected for over 6 months. They should have some intact nerve function and be able to move their joints normally. People with heart issues, pregnancy, joint contractures, severe lung/kidney/blood circulation problems, uncontrolled seizures or psychological issues, obesity, drug abuse, immune deficiencies or frequent infections can't join.

What is being tested?

The study tests an implanted device called IST-16 that uses electrical stimulation to help people with paralysis exercise and improve movement like standing or stepping. It's surgically placed in the body and aims to restore some mobility functions.

What are the potential side effects?

Potential side effects may include discomfort at the implant site, skin irritation from electrodes used during therapy sessions after surgery and possible infection risks associated with surgical implants.

Eligibility Criteria

Inclusion Criteria

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

Select...

I can move all my joints normally.

Select...

I have a spinal cord injury with significant loss of motor or sensory function.

Select...

My lower motor neurons are functioning properly.

Select...

I have a spinal cord injury between C6 and T12 or a condition that causes paralysis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have seizures that my current medication cannot control.

Select...

I am considered obese.

Select...

I often get urinary tract infections.

Select...

I have had fractures without injury or I need insulin for diabetes.

Select...

I have bedsores.

Select...

I have a weakened immune system.

Select...

I have lung problems.

Select...

I have poor blood circulation.

Select...

I have an irregular heartbeat.

Select...

I have stiff joints that can't fully move.

Select...

My kidneys are not working properly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from immediately after intervention and 1 year after intervention

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from immediately after intervention and 1 year after intervention

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from immediately after intervention and 1 year after intervention for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Device reliability and technical performance measuring changes in standing duration from baseline at discharge to 12 months after discharge

Device reliability and technical performance measuring changes in standing loads from baseline at discharge to 12 months after discharge

Device reliability and technical performance measuring changes in walking distance from baseline at discharge to 12 months after discharge

+1 more

Secondary study objectives

Device operability measuring changes in functional activities of daily living from baseline at discharge and 12 months after discharge

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: ImplantExperimental 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 / 15Eligibility criteria met