Implant to improve walking after spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effects of an implanted neural stimulator designed to enhance walking ability in individuals with incomplete spinal cord injuries. Participants will first undergo pre-surgical gait training, followed by the surgical implantation of a device that stimulates nerves to activate muscles involved in walking. The system will be tailored to each participant, utilizing sensors to coordinate muscle contractions based on their specific needs. Over the course of the study, participants will receive training on how to use the device and will be evaluated at various follow-up sessions to assess improvements in their walking capabilities.

Why it matters

Who can join: the full rules

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.

Where it's running

• Louis Stokes Cleveland Veterans Affairs Medical Center
  Cleveland, Ohio, United States Recruiting
• MetroHealth System
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Nathan Makowski, PhD — MetroHealth System, Ohio
• Study coordinator: Lisa Lombardo, MPT
• Email: lisa.lombardo2@va.gov
• Phone: 216-791-3800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.