Spinal Neurorehabilitation for Veterans With SCI

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: Not yet recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Diagnostic test: Neurophysiological and anatomical testing; Device: Transcutaneous Spinal Stimulation

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: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alison Gorbatov; Phone Number: 16367 (401) 271-7100; Email: Alison.Gorbatov@va.gov
• Study Contact Backup: Name: Jonathan Calvert, MD; Phone Number: (401) 273-7100; Email: Jonathan.Calvert2@va.gov

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02908-4734
      • Providence VA Medical Center, Providence, RI
      • Contact: Alison Gorbatov; Phone Number: 16367 (401) 271-7100; Email: Alison.Gorbatov@va.gov
      • Contact: Jonathan Calvert, MD; Phone Number: 401-273-7100; Email: Jonathan.Calvert2@va.gov
      • Principal Investigator: Jonathan Calvert, MD

Participation Criteria

Eligibility Criteria

• 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 MRI scan or performing neurorehabilitation exercises
• Frequent and significant spasticity that may preclude an MRI scan or neurorehabilitation exercises.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

Outcome Measure	Measure Description	Time Frame
Axial completeness of chronic spinal cord injury based on spine MRI	Spared region volume at the injury site as assessed by spine MRI will be compared with clinical SCI score as measured by the ISCNSCI exam.	5 years
Sagittal completeness of chronic spinal cord injury based on spine MRI	Intramedullary lesion length will be measured via spine MRI and compared with clinical SCI score as measured by the ISCNSCI exam.	5 years
Presence of descending connections in chronic spinal cord injury based on transcranial magnetic stimulation	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.	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Research priorities of Veteran spinal cord injury stakeholders	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	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	Participants will self-report any changes in sensation during the application of non-invasive transcutaneous spinal stimulation.	5 years

Collaborators and Investigators

• Sponsor: VA Office of Research and Development
• Investigators: Principal Investigator: Jonathan Calvert, MD, Providence VA Medical Center, Providence, RI

Study record dates

Study Major Dates

• Study Start (Estimated): January 23, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: October 15, 2025
• First Submitted That Met QC Criteria: October 27, 2025
• First Posted (Estimated): October 29, 2025

Study Record Updates

• Last Update Posted (Estimated): October 29, 2025
• Last Update Submitted That Met QC Criteria: October 27, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Neurorehabilitation; Spinal cord stimulation; Transcutaneous stimulation; Neuroanatomy; Spinal neuromodulation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID 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