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Implant for Walking After Incomplete SCI

NCT06965127 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2025-11-26

No results posted yet for this study

Summary

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.

Conditions

  • Spinal Cord Injury (SCI)
  • Gait

Interventions

DEVICE

NNP-LE

Networked NeuroProsthesis - Lower Extremity Configuration (NNP-LE) measuring physiologic command signals and delivering neural stimulation to intramuscular and nerve cuff electrodes for trunk and leg muscle assistance.

Sponsors & Collaborators

  • MetroHealth Medical Center

    collaborator OTHER

  • CDMRP

    collaborator UNKNOWN

  • Louis Stokes VA Medical Center

    lead FED

Principal Investigators

  • Nathan Makowski, PhD · MetroHealth System, Ohio

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-27
Primary Completion
2028-08-31
Completion
2031-08-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06965127 on ClinicalTrials.gov