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

Disqualifiers: Fracture risk, Heterotopic ossification, Uncontrolled spasticity, Diabetes, Hypertension, others

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

Compensation: Varies

Number of Visits: Unknown

5 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device, NNP-LE, which might improve walking in people with incomplete spinal cord injuries. Researchers will implant the device and evaluate its effects on walking over several years. It targets individuals who struggle to walk due to leg or trunk weakness, have some sensation or movement in the affected areas, and cannot walk faster than 0.8 meters per second. Participants should also be able to stand using an assistive device, such as a cane or walker. The trial aims to determine if the implanted device can enhance walking ability and overall mobility. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance mobility for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this implant is safe for improving walking in people with spinal cord injury?

Research shows that the NNP-LE implant, designed to aid walking after a spinal cord injury, is currently undergoing testing for safety and effectiveness. Although specific safety data for this implant is not yet available, studies on similar devices suggest they are generally well-tolerated.

In other studies on spinal cord injury treatments, patients often experience mild to moderate side effects, such as temporary discomfort or pain at the implant site. Serious side effects are rare.

This trial is not limited to just the early or late stages, building on existing knowledge about the safety of similar implants. While some risks exist, previous studies have shown promise, making it a viable option for those interested in participating in clinical research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for spinal cord injury, which often focus on rehabilitation and managing symptoms, the NNP-LE implant offers a groundbreaking approach by directly enhancing walking ability. Researchers are excited about this treatment because it involves implanting a device that works by stimulating the nervous system to restore movement. This innovative method provides a more direct and potentially more effective way to improve mobility for individuals with spinal cord injuries compared to traditional therapies.

What evidence suggests that this device is effective for improving walking after spinal cord injury?

Research has shown that implanted devices can help people with partial spinal cord injuries walk better. In this trial, participants will receive the NNP-LE implant, designed to improve walking by stimulating specific nerves and muscles. Studies have found that similar technologies lead to better movement and more independence for patients. These devices send electrical signals to the muscles, aiding in more effective movement. Early results suggest that these implants may offer significant benefits for those who have difficulty walking after a spinal cord injury. ^{6 7 8 9 10}

Who Is on the Research Team?

Nathan Makowski, PhD

Principal Investigator

MetroHealth System, Ohio

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Louis Stokes VA Medical Center

Lead Sponsor

Trials

21

Recruited

4,100+

MetroHealth Medical Center

Collaborator

Trials

125

Recruited

22,600+

CDMRP

Collaborator

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8472084/

Walking Ability Outcome Measures in Individuals with ... A systematic review was performed to provide an updated qualitative review of walking ability outcome measures in SCI and to analyze their psychometric ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07223710

NCT07223710 | Improving Walking After Spinal Cord Injury De-identified data related to Demographics, clinical outcomes and instrumental data will shared through the NICHD Data ad Specimens Hub (DASH).

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10638838/

Evaluation of the improvement of walking ability in patients ... This article used lower limb rehabilitation robot (LLRR) to improve the walking ability of SCI patients and applied them to SCI rehabilitation.

4. researchgate.net researchgate.net/publication/383336597_Effectiveness_of_virtual-walking_intervention_combined_with_exercise_on_improving_pain_and_function_in_incomplete_spinal_cord_injury_a_feasibility_study

Effectiveness of virtual-walking intervention combined with ... Effectiveness of virtual-walking intervention combined with exercise on improving pain and function in incomplete spinal cord injury: a feasibility study.

5. jneuroengrehab.biomedcentral.com jneuroengrehab.biomedcentral.com/articles/10.1186/s12984-023-01178-9

Data-driven characterization of walking after a spinal cord ... In this work, we present a data-driven approach to assess walking for SCI patients based on sensor-derived outcome measures.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11313443/

Harnessing Artificial Neural Networks for Spinal Cord Injury ... Spinal cord injury (SCI) leads to several severe symptoms, including motor deficits, sensory deficits, and autonomic nervous system dysfunction.

7. pva.org pva.org/wp-content/uploads/2021/09/cpg_outcomes-following-traumatic-sci.pdf

Outcomes Following Traumatic Spinal Cord Injury These outcome statistics have been reported in the literature or documented in data- bases, and they coincide with the consensus expectations of clinical ...

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6786403/

Risk-benefit value of upper extremity function by an ... When analysing the results based on all degrees of interest, more than 64% of responders were interested in getting the NNP with a success rate ...

9. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024006005

The possible neural mechanism of neuropathic pain ... In this study, we observed pediatric complete spinal cord injury (CSCI) patients receiving MI training and divided them into different ...

10. liebertpub.com liebertpub.com/doi/10.1089/neu.2022.0403?doi=10.1089/neu.2022.0403

North American Clinical Trials Network for Spinal Cord ... The data tracks a patient's acute care and follow-up from admission to a NACTN center to 12 months post-injury. As of January 2022, 1017 individuals have been ...