Implant for Walking After Spinal Cord Injury

Overseen By Maura Malenchek, PTA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cleveland VA Medical Research and Education Foundation

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

5 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a device study that will evaluate the effect of an implanted stimulator on improving walking in people with incomplete spinal cord injury. There are two phases in the study: 1) Screening - this phase determines if the individual is a good candidate to receive an implanted system, 2) Implantation, controller development, and evaluation - this phase includes implanting the device and setting the individual up for system use, creating controllers for walking, and evaluating the effect of the device over a couple years.

Research Team

Nathan Makowski, PhD

Principal Investigator

MetroHealth System, Ohio

Eligibility Criteria

This trial is for individuals with an incomplete spinal cord injury who are looking to improve their walking ability. Candidates must pass a screening phase to ensure they're suitable for receiving the implanted system.

Inclusion Criteria

Appropriate body habitus

Willingness to comply with follow-up procedures

Neurologically stable as determined by a physician

Exclusion Criteria

Non-English speaking

Uncontrolled spasticity that would interfere with study activities

Disorder or condition that require MRI monitoring

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implantation and Controller Development

Participants undergo surgery to implant the device and develop controllers for walking

Several months

Training and Evaluation

Participants are trained to use the implanted device and evaluated for improvements in walking

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after training

4 weeks

Treatment Details

Interventions

• NNP-LE

Trial Overview The study is testing NNP-LE, an implantable stimulator designed to enhance walking in people with incomplete spinal cord injuries. It involves a screening phase followed by device implantation and long-term evaluation of its effectiveness.

Participant Groups

Group I: Implantation, controller development and evaluation Experimental Treatment 1 Intervention

This phase includes installing the device and setting the individual up for use of the system and evaluating the effect of the system on walking ability.

Who Is Running the Clinical Trial?

Cleveland VA Medical Research and Education Foundation

Lead Sponsor

Trials

2

Recruited

530+

MetroHealth Medical Center

Collaborator

Trials

125

Recruited

22,600+