Recruiting

Implant

Sponsor:

Louis Stokes VA Medical Center

Code:

NCT06965127

Conditions

Spinal Cord Injury (SCI)

Gait

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

NNP-LE

Study Details

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.

Conditions

Spinal Cord Injury (SCI)

Gait

Study ID

NCT06965127

Start date

Aug 27, 2025

Status verified date

May, 2025

Completion date

Aug, 2031

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

5 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

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.

Primary outcome measure

  • Difference in maximum walking distance [ Time Frame: Immediately after the participant is fully trained to use their implanted system ]

Central Contacts and Locations

Central contacts

Lisa Lombardo, MPT

216-791-3800lisa.lombardo2@va.gov

Maura Malenchek, PTA

216-791-3800maura.malenchek@va.gov

Locations

Louis Stokes Cleveland Veterans Affairs Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Lisa Lombardo, MPT

216-791-3800lisalombardo2@va.gov

Maura Malenchek, PTA

216-791-3800maura.malenchek@va.gov

Principal Investigator:

Nathan Makowski, PhD

More Information

Sponsor

Louis Stokes VA Medical Center

Last update posted

Nov 26, 2025

Last verified

May, 2025

Keywords

  • neuroprosthesis
  • implanted device

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Louis Stokes VA Medical Center on 2025-11-26.