Spinal Neurorehabilitation for Veterans With SCI

Part of paid clinical trials in Providence, Rhode Island.

Sponsor
VA Office of Research and Development
Study ID
NCT07222046
Status
Not Yet Recruiting

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Conditions

  • Spinal Cord Injuries

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jan 23, 2026
Status verified
Oct 2025
Primary completion
Dec 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

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

Primary Outcome Measure

Axial completeness of chronic spinal cord injury based on spine MRI [ Time Frame: 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Providence VA Medical Center, Providence, RIProvidenceRhode Island02908-4734
Jonathan Calvert, MD
[email protected]
401-273-7100
Alison Gorbatov
[email protected]
(401) 271-7100
Jonathan Calvert, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Providence VA Medical Center, Providence, RI· Providence, RI

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