Spinal Neurorehabilitation for Veterans With SCI

September 1, 2026 updated by: VA Office of Research and Development

Identifying Residual Connectivity in Veterans With Spinal Cord Injury for Precision Neurorehabilitation

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The International Standards for Neurological Classification of SCI (ISNCSCI) exam is used to classify spinal cord injury (SCI) severity by determining the neurological injury level and functional completeness of SCI. However, anatomical, physiological, and functional studies have indicated that many participants with ISNCSCI-defined complete SCI retain connectivity through the SCI lesion. Due to the heterogeneity of SCI and the small-N in prior spinal neuromodulation studies, there are no diagnostic criteria to determine how SCI lesion profile affects the ability to restore sensorimotor function in the presence of spinal neuromodulation. Development of this knowledge is necessary to design precise spinal neuromodulation approaches and clinical trials that could restore function and improve quality of life for Veterans with chronic SCI. First, stakeholders will be engaged to define research priorities, meaningful outcomes, and barriers to participation in neuromodulation trials. The potential impact of neuromodulation and priorities of Veterans with SCI and their caretakers will be assessed across a nationwide survey. Spinal neuromodulation will be evaluated to determine how it could impact clinical practice and treatment of Veterans though survey of SCI physicians. Qualitative feedback will be obtained from Veterans with SCI regarding the expected and achieved outcomes with neuromodulation prior to and after undergoing functional neuromodulation experiments. Next, baseline anatomical and physiological connectivity measurements across ISNCSCI scores will be established. Veterans with SCI across INSCSCI grades will be recruited to determine residual spinal connectivity. Spinal cord anatomy will be assessed above, below, and at the SCI lesion through MR neuroimaging. Descending corticospinal connectivity will be evaluated with transcranial magnetic stimulation and ascending afferent signals will be evaluated through somatosensory evoked potentials. Finally, functional spinal connectivity during spinal neuromodulation will be evaluated. Volitional motor output will be assessed with and without non-invasive spinal neuromodulation. The sensory effects of spinal neuromodulation will be assessed through user reports of pain and somatosensation. Potential functional improvements in activities of daily living will be assessed with and without spinal neuromodulation.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95655-4200
        • Recruiting
        • VA Northern California Health Care System, Mather, CA
        • Contact:
        • Principal Investigator:
          • Jonathan S Calvert, PhD MD

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single-arm
This is a single-arm study where all participants will undergo the same neurophysiological, imaging, and functional testing.
Diagnostic test: 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).
Device: 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.
Other Names:
  • Digitimer DS7

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Presence of descending connections in chronic spinal cord injury based on transcranial magnetic stimulation
Time Frame: 5 years
The latency of transcranial magnetic stimulation pulses will be measured via electromyography and compared with clinical SCI score as measured by the ISCNSCI exam.
5 years
Presence of ascending connections in chronic spinal cord injury based on somatosensory evoked potentials.
Time Frame: 5 years
The latency of somatosensory evoked potential pulses will be measured via electromyography and compared with clinical SCI score as measured by the ISCNSCI exam.
5 years
Axial completeness of chronic spinal cord injury (SCI) based on spine magnetic resonance imaging (MRI)
Time Frame: 5 years
Spared region volume at the injury site as assessed by spine MRI will be compared with clinical SCI score as measured by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam.
5 years
Sagittal completeness of chronic spinal cord injury (SCI) based on spine magnetic resonance imaging (MRI)
Time Frame: 5 years
Intramedullary lesion length will be measured via spine MRI and compared with clinical SCI score as measured by the ISCNSCI exam.
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Research priorities of Veteran spinal cord injury stakeholders
Time Frame: 2 years
The research priorities of Veterans with chronic spinal cord injury will be obtained and compared with previously published results in the non-Veteran population.
2 years
Voluntary motor function in the presence of non-invasive stimulation
Time Frame: 5 years
Increases in electromyography will be assessed with and without the use of non-invasive transcutaneous spinal stimulation.
5 years
Sensory responses in the presence of non-invasive stimulation
Time Frame: 5 years
Participants will self-report any changes in sensation during the application of non-invasive transcutaneous spinal stimulation.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jonathan S Calvert, PhD MD, VA Northern California Health Care System, Mather, CA

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 31, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2031

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2031

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 15, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 27, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 29, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RRD8-003-24W

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The PI will share de-identified datasets and results collected through this proposal by depositing these data at the National Library of Medicine (NLM) PubMed Central website repository as this is a VA supported data repository. The raw and processed neurophysiological data will be shared with supplementary metadata that includes information about the study methodology used to collect the data, details about the code, and definitions of variables.

IPD Sharing Time Frame

The data will be posted following publication of the data in a scientific journal. It is anticipated that this project will produce approximately 1 publication per year after the second year, with the data published simultaneously. All of the data will be published at the conclusion of the study in five years. The deidentified data will be posted on publicly accessible servers and will be stored there permanently.

IPD Sharing Access Criteria

Deidentified data will be accessible by all who interested parties. Any further requests will be made and reviewed by the PI.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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