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RECRUITING Not applicable ClinicalTrials.gov

Spinal Neurorehabilitation for Veterans With SCI

Sponsor: VA Office of Research and Development • ClinicalTrials.gov ID: NCT07222046

Registry updated: 2026-09-04
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Description

Chronic spinal cord injury (SCI) is a debilitating disorder in Veterans and the broader U.S. population that does not have a cure. Veterans with severe SCI demonstrate permanent loss of sensory and motor function below their injury resulting in decreased quality of life and independence. Recently, electrical spinal neuromodulation has emerged as a potential approach to restore voluntary motor function and locomotion in persons with chronic SCI. However, spinal neuromodulation has yet to translate to clinical use due to small sample sizes in research studies and a lack of information on which patients would benefit. Here, the investigators propose a novel approach to evaluate the priorities and barriers faced by Veterans with SCI to use spinal neuromodulation, understand the neural connections remaining in Veterans with severe SCI, and determine potential functional improvements using non-invasive spinal neuromodulation technology. This research represents the first step towards deploying techniques that could dramatically improve function and quality of life for Veterans with SCI.

Interventions

  • Neurophysiological and anatomical testing (Diagnostic test)
    All participants will undergo neurophysiological testing (transcranial magnetic stimulation and somatosensory evoked potentials) to determine residual neural connectivity. All participants will also undergo MRI of the spine to evaluate residual neural connections and changes above and below lesion. These values will be compared to the standard clinical evaluation of spinal cord injury (ISNCSCI exam).
  • Transcutaneous Spinal Stimulation (Device)
    All participants will undergo spinal neuromodulation through non-invasive transcutaneous spinal stimulation to determine the effects on voluntary motor function, sensation, and activities of daily living.

Eligibility criteria

Inclusion Criteria: * All participants must be able to independently read and understand study information materials necessary to ensure informed consent * All participants must have a chronic spinal cord injury occurring \>1 year prior to study enrollment * Ability to follow simple commands in English Exclusion Criteria: * Contraindications to the use of external magnetic or electrical stimulation (e.g., epilepsy, intracranial metal, implanted electrosensitive device, etc.) * Significant neurological comorbidities that may affect neurophysiological recordings * Functional disability prior to spinal cord injury * Visual or auditory disorders limiting ability to participate in study procedures * Pregnancy * Primary psychiatric disorders or dissociative mental symptoms that impair informed consent * Significant chronic pain that may preclude an magnetic resonance imaging (MRI) scan or performing neurorehabilitation exercises * Frequent and significant spasticity that may preclude an MRI scan or neurorehabilitation exercises

Conditions

Spinal Cord Injuries

Locations

  • VA Northern California Health Care System, Mather, CA — Sacramento, California, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record