Recruiting

Spinal NeuromodulationSpinal Neurorehabilitation for Veterans With SCI

Sponsor:

VA Office of Research and Development

Code:

NCT07222046

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Neurophysiological and anatomical testing

Transcutaneous Spinal Stimulation

Study Details

Brief summary:

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.

Conditions

Spinal Cord Injuries

Study ID

NCT07222046

Start date

Aug 31, 2026

Status verified date

Aug, 2026

Completion date

Jun 30, 2031

Anticipated

Primary completion date

Jun 30, 2031

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Single-arm

This is a single-arm study where all participants will undergo the same neurophysiological, imaging, and functional testing.

Interventions

Neurophysiological and anatomical testing

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

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.

Primary outcome measure

Axial completeness of chronic spinal cord injury (SCI) based on spine magnetic resonance imaging (MRI) [ Time Frame: 5 years ]
Sagittal completeness of chronic spinal cord injury (SCI) based on spine magnetic resonance imaging (MRI) [ Time Frame: 5 years ]
Presence of descending connections in chronic spinal cord injury based on transcranial magnetic stimulation [ Time Frame: 5 years ]
Presence of ascending connections in chronic spinal cord injury based on somatosensory evoked potentials. [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Jonathan S Calvert, PhD MD

(916) 843-7512 Jonathan.Calvert2@va.gov

Locations

VA Northern California Health Care System, Mather, CA

Recruiting

Sacramento, California, United States, 95655-4200

Contacts

Jonathan S Calvert, PhD MD

(916) 843-7512 Jonathan.Calvert2@va.gov

Principal Investigator:

Jonathan S Calvert, PhD MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Sep 4, 2026

Last verified

Aug, 2026

Keywords

Spinal neuromodulation
Transcutaneous stimulation
Spinal cord stimulation
Neuroanatomy
Neurorehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-09-04.