Spinal Neurorehabilitation for Veterans With SCI

NCT07222046 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: RRD8-003-24W
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Spinal neuromodulation; Transcutaneous stimulation; Spinal cord stimulation; Neuroanatomy; Neurorehabilitation

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (3)

• Research priorities of Veteran spinal cord injury stakeholders

  2 years

• Voluntary motor function in the presence of non-invasive stimulation

  5 years

• Sensory responses in the presence of non-invasive stimulation

  5 years

Study Arms (1)

Single-arm

EXPERIMENTAL

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

Diagnostic Test: Neurophysiological and anatomical testing; Device: Transcutaneous Spinal Stimulation

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).

Single-arm

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.

Also known as: Digitimer DS7

Single-arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Providence VA Medical Center, Providence, RI

Providence, Rhode Island, 02908-4734, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Jonathan Calvert, MD

  Providence VA Medical Center, Providence, RI

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jonathan Calvert, MD

CONTACT

(401) 273-7100; Jonathan.Calvert2@va.gov

Alison Gorbatov

CONTACT

(401) 271-7100; Alison.Gorbatov@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Due to the uniqueness of each injury, all staff will be aware of each participant's history. All participants will receive the same intervention.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: All participants will be Veterans with spinal cord injury to evaluate neurophysiological and functional effects of non-invasive spinal neuromodulation.

Study Record Dates

• First Submitted: October 15, 2025
• First Posted: October 29, 2025
• Study Start: January 23, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• 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.
• Access Criteria: Deidentified data will be accessible by all who interested parties. Any further requests will be made and reviewed by the PI.

Locations

US (1)