Implant for Walking After Incomplete SCI

NCT ID: NCT06965127

Last Updated: 2025-11-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-27
• Study Completion Date: 2031-08-31

Brief 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.

Detailed Description

The purpose of this study is to evaluate the effects of neural stimulation for improving walking after incomplete spinal cord injury. Participants will conduct pre-surgical gait training and then undergo surgery to implant a stimulator and electrodes to sense from and activate muscles used during walking. The device delivers electrical pulses to the nerves causing the muscles to contract to perform functional movements. The system coordinates assistance based on implanted sensors. After receiving the implanted device, participants undergo training to use the device to assist walking. Evaluations are completed prior to surgery as well after training and at later follow up sessions.

Conditions

Spinal Cord Injury (SCI); Gait

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Implantation, controller development and evaluation

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.

Group Type: EXPERIMENTAL

NNP-LE

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Between the ages of 18-75
• Non-ventilator dependent paralysis resulting from injuries such as: cervical/thoracic spinal cord injuries affecting the trunk and/or lower limbs
• Impairment classification of AIS B, C, or D (preservation of sensation and/or some motor function) with weakness in trunk and/or lower extremity muscles
• Unable to walk faster than 0.8m/s during a 10m walk test
• Gait deviation such as reduced peak hip, knee, and/or ankle range of motion during stance or swing phases due to motor impairment
• Time post injury greater than six months
• Innervated and excitable lower extremity and trunk musculature
• Adequate social support and stability
• Willingness to comply with follow-up procedures
• Appropriate body habitus (height and weight within acceptable limits as determined by study physician)
• Neurologically stable as determined by a physician

Exclusion Criteria

• Significant fracture risk or history of spontaneous fractures
• History of heterotopic ossification at the hip, knee, or ankle
• Non-English speaking
• Insufficient upper extremity function to use an assistive device (e.g. walker or cane)
• Females who are pregnant
• Current pressure injury that would be exacerbated by study activities
• Uncontrolled spasticity that would interfere with study activities
• Significant range of motion limitations that would compromise study activities
• History of vestibular dysfunction, balance problems, or spontaneous falls
• Disorder or condition that require MRI monitoring
• Acute and/or untreated orthopedic issues that would prevent weight bearing or exercising implanted muscles such as a dislocation or fracture
• Acute and/or chronic medical problems left untreated or not controlled that would increase risk by using stimulation such as cardiac abnormalities, immunological/pulmonary/renal/circulatory compromise
• Uncontrolled diabetes or hypertension
• Presence of a demand pacemaker, cardiac defibrillator, or neuroprosthesis system with components in the legs
• Any other medical or psychological condition that would be a contraindication

Implant eligibility criteria

• In addition to all of the above, the participant must be able to fully support their body weight in standing with an assistive device prior to implantation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MetroHealth Medical Center

OTHER

Sponsor Role: collaborator

CDMRP

UNKNOWN

Sponsor Role: collaborator

Louis Stokes VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Nathan Makowski

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nathan Makowski, PhD

Role: PRINCIPAL_INVESTIGATOR

MetroHealth System, Ohio

Locations

Louis Stokes Cleveland Veterans Affairs Medical Center

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Lisa Lombardo, MPT

Role: CONTACT

lisa.lombardo2@va.gov

216-791-3800 ext. 64909

Maura Malenchek, PTA

Role: CONTACT

maura.malenchek@va.gov

216-791-3800 ext. 64989

Facility Contacts

Lisa Lombardo, MPT

Role: primary

lisalombardo2@va.gov

216-791-3800 ext. 64909

Maura Malenchek, PTA

Role: backup

maura.malenchek@va.gov

216-791-3800 ext. 64989

Other Identifiers

CDMRP-SC230198

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

1802378

Identifier Type: -

Identifier Source: org_study_id