Spinal Cord InjuriesNCT07222046
Spinal Neurorehabilitation for Veterans With SCI
A study testing Neurophysiological and anatomical testing and Transcutaneous Spinal Stimulation in people with Spinal Cord Injuries, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Neurophysiological and anatomical testing and Transcutaneous Spinal Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2026to 30 Jun 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA Northern California Health Care System, Mather, CA
Sacramento, California, 95655-4200
Jonathan S Calvert, PhD MD, (916) 843-7512, Jonathan.Calvert2@va.gov
Jonathan S Calvert, PhD MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Neurophysiological and anatomical testing, Transcutaneous Spinal Stimulation
- Keywords
- Spinal neuromodulation, Transcutaneous stimulation, Spinal cord stimulation, Neuroanatomy, Neurorehabilitation
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neurophysiological and anatomical testingDiagnostic 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 StimulationDevice
Also called Digitimer DS7
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 group | Role | What they receive |
|---|---|---|
| Single-arm | Experimental | This is a single-arm study where all participants will undergo the same neurophysiological, imaging, and functional testing. Receives: Diagnostic Test: Neurophysiological and anatomical testing; Device: Transcutaneous Spinal Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Axial completeness of chronic spinal cord injury (SCI) based on spine magnetic resonance imaging (MRI)
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.
Measured: 5 years
Sagittal completeness of chronic spinal cord injury (SCI) based on spine magnetic resonance imaging (MRI)
Intramedullary lesion length will be measured via spine MRI and compared with clinical SCI score as measured by the ISCNSCI exam.
Measured: 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.
Measured: 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.
Measured: 5 years
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start31 Aug 2026
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will be Veterans with spinal cord injury to evaluate neurophysiological and functional effects of non-invasive spinal neuromodulation.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Jonathan S Calvert, PhD MD, Principal investigator, VA Northern California Health Care System, Mather, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07222046
- Sponsor's protocol ID
- RRD8-003-24W
- Status last verified
- Aug 2026
- First submitted
- 15 Oct 2025
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Residual Connectivity in Veterans With Spinal Cord Injury for Precision Neurorehabilitation
- ClinicalTrials.gov ID
- NCT07222046
- Acronym / sponsor ID
- RRD8-003-24W
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal neuromodulation, Transcutaneous stimulation, Spinal cord stimulation, Neuroanatomy, Neurorehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 31 Aug 2026 (actual)
- Primary completion
- 30 Jun 2031 (estimated)
- Study completion
- 30 Jun 2031 (estimated)
- First posted
- 29 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be Veterans with spinal cord injury to evaluate neurophysiological and functional effects of non-invasive spinal neuromodulation.
| Arm | Type | Receives |
|---|---|---|
| Single-arm | Experimental | Diagnostic Test: Neurophysiological and anatomical testing, Device: Transcutaneous Spinal StimulationThis is a single-arm study where all participants will undergo the same neurophysiological, imaging, and functional testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurophysiological and anatomical testingAll 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). | Diagnostic test | Single-arm |
| Transcutaneous Spinal StimulationAlso: Digitimer DS7All 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. | Device | Single-arm |
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
Research priorities of Veteran spinal cord injury stakeholders
Time frame: 2 years
Voluntary motor function in the presence of non-invasive stimulation
Time frame: 5 years
Sensory responses in the presence of non-invasive stimulation
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jonathan S Calvert, PhD MD principal investigator
VA Northern California Health Care System, Mather, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurophysiological and anatomical testing and Transcutaneous Spinal Stimulation in people with Spinal Cord Injuries, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jonathan S Calvert, PhD MD ((916) 843-7512, Jonathan.Calvert2@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Axial completeness of chronic spinal cord injury (SCI) based on spine magnetic resonance imaging (MRI) (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.