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RecruitingNCT07738978Updated Nov 2, 2026

Understanding and Enhancing Human Health and Movement

An interventional study of Neural Prosthesis in Spinal Cord Injury, Stroke (CVA) or Transient Ischemic Attack and Multiple Sclerosis, sponsored by Louis Stokes VA Medical Center. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Louis Stokes VA Medical Center · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 3 months after the study started (first participant enrolled Mar 2021, registered Jul 2026).
  • Started Mar 2021; still recruiting 5 years 7 months later.
Updated Nov 2, 2026Primary outcomes revisedInterventions changedGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
75
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

By doing this study, investigators hope to learn how electrical stimulation can improve human movement, biomechanics, and function and to gather information on the safety and effectiveness of an implanted electrical stimulation system after paralysis from spinal cord injury, stroke, multiple sclerosis, and traumatic brain injury.

Read the detailed description

The purpose of this research study is to better understand how people move, so investigators can develop improved ways to help individuals with lower-limb and/or trunk paralysis perform everyday activities such as sitting, reaching, pushing a wheelchair, transferring, standing, stepping, and maintaining balance.

This study evaluates how activating stabilizing muscles, either with surface electrical stimulation or with an implanted neural stimulation device may change the way these daily activities are performed and potentially enhance functional independence.

A key goal of this project is to collect information on the safety and effectiveness of an implanted neural stimulation system. The U.S. Food and Drug Administration (FDA) permits the limited investigational use of this implanted system for individuals with lower-limb and/or trunk paralysis resulting from neurological conditions.

02

Conditions studied

  • Spinal Cord Injury
  • Stroke (CVA) or Transient Ischemic Attack
  • Multiple Sclerosis

Keywords

  • paralysis
  • electrical stimulation
  • neuroprosthesis
  • implanted device
03

In context

Spinal Cord Injuries

2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.

This study's planned enrollment of 75 is above the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

Louis Stokes VA Medical Center is the lead sponsor of 15 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Skeletal maturity and ability to sign (>18 years)
  • Non-ventilator dependent paralysis resulting from injuries such as: mid cervical/thoracic (C4 or below) spinal cord injuries, poststroke hemiparesis, TBI, or MS, affecting the trunk and/or lower limbs
  • Innervated and excitable lower extremity and trunk musculature
  • Adequate social support and stability
  • Willingness to comply with follow-up procedures
  • Time post injury greater than six months
  • Appropriate body habitus (height and weight within acceptable limits as determined by study physician)
  • Neurologically stable as determined by a physician

Exclusion criteria

Exclusion Criteria:

  • Non-English speaking
  • Females who are pregnant
  • Current pressure injuries that would be exacerbated by study activities
  • Severe contractures or uncontrolled spasticity of any major joint of the upper or lower extremities that results in a fixed deformity that would interfere with study activities
  • History of spontaneous fractures or other evidence of excessively low bone density
  • History of vestibular dysfunction, balance problems, or spontaneous falls
  • Acute and or/untreated orthopedic problems that would prevent a participant from weight bearing or exercising such as a dislocation or fracture.
  • Acute and/or chronic problems left untreated or not controlled that would put a participant at risk by using stimulation such as cardiac abnormalities, immunological/pulmonary/renal/circulatory compromise, diabetes or hypertension
  • Presence of a demand pacemaker or cardiac defibrillator
  • Any other medical or psychological condition that would be a
  • Current pressure ulcers
  • Significant range of motion limitations that would compromise study activities
  • Body habitus that would compromise study activities
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Experimental
    Neural Stimulation for Standing, Stepping, or Trunk

    This arm is specific for individuals implanted for standing, stepping or trunk activities

    Device: Neural Prosthesis

Interventions

  • DeviceNeural Prosthesis

    implanted electrical stimulation device

    Also known as: IST-16, IST-12, IRS-8, Spiral Cuff

06

What researchers measure

Primary outcomes

  1. Max Standing Time

    specific to individuals implanted for standing activities

    Time frame: Study completion - an average of 1 year

  2. Percent body weight

    specific to individuals implanted for standing activities

    Time frame: Study completion - an average of 1 year

  3. Walking Distance

    specific to individuals implanted for walking activities

    Time frame: Study completion - an average of 1 year

  4. Walking Time

    specific to individuals implanted for walking activities

    Time frame: Study completion - an average of 1 year

  5. Modified functional reach

    specific to individuals implanted for sitting activities

    Time frame: Study completion - an average of 1 year

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Interventions
Arm changed Neural Stimulation→Neural Stimulation for Standing, Stepping, or Trunk
Nov 2, 2026
Primary outcomes
2 edited, 3 added
What changed in the outcomes
  • EditedDifference in Max Standing TimeTime frame: Study completion - an average of 1 year
  • EditedDifference in Max Walking distanceDistanceTime frame: Study completion - an average of 1 year
  • AddedPercent body weightTime frame: Study completion - an average of 1 year
  • AddedWalking TimeTime frame: Study completion - an average of 1 year
  • AddedModified functional reachTime frame: Study completion - an average of 1 year
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    Primary outcomes 2 edited, 3 added
    What changed in the outcomes
    • EditedDifference in Max Standing TimeTime frame: Study completion - an average of 1 year
    • EditedDifference in Max Walking distanceDistanceTime frame: Study completion - an average of 1 year
    • AddedPercent body weightTime frame: Study completion - an average of 1 year
    • AddedWalking TimeTime frame: Study completion - an average of 1 year
    • AddedModified functional reachTime frame: Study completion - an average of 1 year
    Interventions Arm changed Neural Stimulation→Neural Stimulation for Standing, Stepping, or Trunk

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07738978
Lead sponsor
Louis Stokes VA Medical Center
Responsible party
Nathan Makowski (Principal Investigator, Louis Stokes VA Medical Center) — Principal investigator
First posted
Jul 31, 2026
Start date
Mar 21, 2021
Primary completion
Mar 21, 2031 (estimated)
Completion
Mar 21, 2034 (estimated)
Last update
Nov 2, 2026

Study contacts

Maura Malenchek, PTA
Contact
maura.malenchek@va.gov
216-791-3800 ext. 64989
Lisa Lombardo, MPT
Contact
lisa.lombardo2@va.gov
2167913800 ext. 64909

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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