RECRUITING

Implant for Walking After Incomplete SCI

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Enhancing Walking and Independence After Incomplete SCI With a Fully Implanted Neuroprosthesis

Quick Facts

Study Start:2025-05
Study Completion:2031-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06965127

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between the ages of 18-75
  2. * Non-ventilator dependent paralysis resulting from injuries such as: cervical/thoracic spinal cord injuries affecting the trunk and/or lower limbs
  3. * 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
  4. * Unable to walk faster than 0.8m/s during a 10m walk test
  5. * Gait deviation such as reduced peak hip, knee, and/or ankle range of motion during stance or swing phases due to motor impairment
  6. * Time post injury greater than six months
  7. * Innervated and excitable lower extremity and trunk musculature
  8. * Adequate social support and stability
  9. * Willingness to comply with follow-up procedures
  10. * Appropriate body habitus (height and weight within acceptable limits as determined by study physician)
  11. * Neurologically stable as determined by a physician
  1. * Significant fracture risk or history of spontaneous fractures
  2. * History of heterotopic ossification at the hip, knee, or ankle
  3. * Non-English speaking
  4. * Insufficient upper extremity function to use an assistive device (e.g. walker or cane)
  5. * Females who are pregnant
  6. * Current pressure injury that would be exacerbated by study activities
  7. * Uncontrolled spasticity that would interfere with study activities
  8. * Significant range of motion limitations that would compromise study activities
  9. * History of vestibular dysfunction, balance problems, or spontaneous falls
  10. * Disorder or condition that require MRI monitoring
  11. * Acute and/or untreated orthopedic issues that would prevent weight bearing or exercising implanted muscles such as a dislocation or fracture
  12. * 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
  13. * Uncontrolled diabetes or hypertension
  14. * Presence of a demand pacemaker, cardiac defibrillator, or neuroprosthesis system with components in the legs
  15. * Any other medical or psychological condition that would be a contraindication

Contacts and Locations

Study Contact

Lisa Lombardo, MPT
CONTACT
216-791-3800
lisa.lombardo2@va.gov
Maura Malenchek, PTA
CONTACT
216-791-3800
maura.malenchek@va.gov

Principal Investigator

Nathan Makowski, PhD
PRINCIPAL_INVESTIGATOR
MetroHealth System, Ohio

Study Locations (Sites)

Louis Stokes Cleveland Veterans Affairs Medical Center
Cleveland, Ohio, 44106
United States

Collaborators and Investigators

Sponsor: Cleveland VA Medical Research and Education Foundation

  • Nathan Makowski, PhD, PRINCIPAL_INVESTIGATOR, MetroHealth System, Ohio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05
Study Completion Date2031-08

Study Record Updates

Study Start Date2025-05
Study Completion Date2031-08

Terms related to this study

Keywords Provided by Researchers

  • neuroprosthesis
  • implanted device

Additional Relevant MeSH Terms

  • Spinal Cord Injury (SCI)
  • Gait