An interventional study of RTI Xcite and ExaStim in Non Traumatic Spinal Cord Injury, Sub-Acute Rehabilitation and Spinal Cord Injury Cervical, sponsored by Center for Veterans Research and Education. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Center for Veterans Research and Education · Not applicable, Interventional, and Treatment
Among 968 studies in Spinal Cord Injuries with a site in United States — 250 open to participants now, 308 under way, 7 of them phase 3. Spinal Cord Injuries · United States.
Among the 968 studies in Spinal Cord Injuries with a site in United States, this one is the 444th largest by planned enrollment of the 836 interventional ones that give a count, is one of 71 that started in 2026, is one of 601 with no phase, reaches primary completion later than 285 of the 307 other live ones, and was the 966th registered.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
Browse Spinal Cord Injuries studies →250 of the 968 studies in Spinal Cord Injuries with a site in United States are open now. Recruiting first, the newest first:
Johns Hopkins University · Sites in United States
University of Miami · Sites in United States
Neuralink Corp · Sites in United States
Rahul Sachdeva · Sites in United States
Northwell Health · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 375 Spinal Cord Injuries studies recruiting now, 166 (44%) set no upper age limit and 158 (42%) stop at 75 or younger; 41 take children under 18; 52 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
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968 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 94 · Phase 2 132 · Phase 3 39 · Phase 4 27
First in 1986; this study’s year is marked. 71 started in 2026.
This study's planned enrollment of 20 is below the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Median enrollment 24 across the 836 interventional studies, 58 across the 128 observational. Of the 576 that completed or were terminated, 223 (39%) have results posted.
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75 of 968 have an industry lead sponsor. The 10 most frequent:
Center for Veterans Research and Education is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
Center for Veterans Research and Education has 1 study filed under Spinal Cord Injuries — fewer than ten, so there is no comparison to draw.
120 of the studies in Spinal Cord Injuries with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05903859Phase 3University of MiamiImprovement of Reproductive Function in Men With Spinal Cord Injury (SCI) | 2027-05-31 |
| NCT07625332Phase 3Northwell HealthPilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI) | 2027-08 |
| NCT03930056Shirley Ryan AbilityLabC-Brace II Spinal Cord Injury | 2026-11 |
| NCT04077346University of LouisvilleNeuromodulation of Spinal Locomotor Circuitry to Elicit Stepping After Pediatric Spinal Cord Injury | 2026-11 |
| NCT05423600Virginia Commonwealth UniversityTransspinal Stimulation With and Without Blood Flow Restricted Exercise Via Telehealth in Persons With Tetraplegia | 2026-11 |
Among the 968 studies in Spinal Cord Injuries with a site in United States, from their registry updates:
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Cervical spinal cord injuries (SCI) are the most common form of spinal cord injuries within the veteran population. Losing arm function is a major concern with these injuries. Doctors often use a treatment called functional electrical stimulation (FES) during rehab sessions targeted at improving arm and hand function. For FES, clinicians places sticky pads on the skin over the muscles that need to move. A newer treatment, called transcutaneous spinal stimulation (TSS), places the pads on the skin over the spine instead. This study compares the two treatments in veterans with non-traumatic spinal cord injuries while they are in the hospital's rehab program. The main goal is to see how well each treatment improves arm and hand function, which is measured with the Capabilities of Upper Extremity Test. If TSS works well, it could help veterans regain more arm and hand function which may result in increased independence.
Cervical spinal cord injuries (SCI) are the most prevalent form of spinal cord injuries within the veteran population. Cervical spinal cord injuries can result in functional limitations to both the lower and upper extremities. Among cervical SCI patients, addressing loss of function in the upper extremities is an extremely important issue to address. Current strategies to treat cervical spinal cord injuries during sub-acute rehabilitation incorporate functional electrical stimulation (FES), with electrodes placed on the skin directly over the targeted muscle groups. With this study current standard care FES will be compared with a new type of muscle stimulation - transcutaneous spinal stimulation (TSS) using the ExaStim® Stimulation System - where electrodes are placed on the skin over the spine. This study is a randomized controlled trial comparing the experimental use of TSS vs FES/standard care among veterans with non-traumatic spinal cord injury during their inpatient sub-acute stay. Outcome evaluations include physical outcome measures and patient-reported outcomes. The primary outcome measure is the Capabilities of Upper Extremity Test. Data will be collected by staff who are blinded to participants' group assignment. This study will provide evidence on the potential benefits of a promising new rehabilitation treatment modality - TSS - for supporting veterans with cervical SCI in achieving optimal outcomes in function and independence.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Veterans admitted to the Minneapolis VA Health Care System's (MVAHCS) SCI inpatient unit for sub-acute rehabilitation following non-traumatic cervical SCI.
Exclusion Criteria:
Study clinicians determine that the veteran would likely not benefit from FES.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RTI Xcite
Device: RTI Xcite
ExaStim
Device: ExaStim
Functional electrical stimulation
Transcutaneous spinal stimulation
Capabilities of Upper Extremity Test (CUE-T)
A performance measure focused on quantifying upper limb limitations and impairment. The CUE-T assesses 17-19 tasks including reaching, lifting (up to 2kg), wheelchair push up, dynamometer strength testing, and active range of motion. Scoring is scored from 0 (unable) to 4 (no difficulty) with high scores indicating better upper limb function. This measure will be completed by a study staff (licensed physical or occupational therapist) who is blinded to treatment allocation. This instrument typically requires 15-30 minutes to complete. CUE-T evaluation sessions will be video-recorded so that observations of participant activities can be validated for study purposes. These video recordings will be destroyed as soon as the CUE-T assessment score has been finalized (within 2 weeks of completing the CUE-T.)
Time frame: Baseline, 4-week, 8-week
Upper Extremity Motor Score UEMS
The UEMS is an upper limb strength assessment of upper limb muscles stratified by spinal nerve level innervation, using traditional manual muscle testing scoring (0-5/5). This requires the participant to demonstrate available movement against gravity, then if full movement is available that motion could be tested against resistance of the tester. If unable to move against gravity the muscles would be tested in gravity eliminated position (ie., horizontal plane) for active range of motion for full/partial range or palpable activity of the targeted muscle group. These tests are consistent with clinical practice to assess spinal cord injury level. This subscale may be performed by the blinded assessor if not completed by clinical staff as part of the ASIA Impairment Scale/International Standards for Neurological Classification of Spinal Cord Injury (AIS/ISNCSCI).
Time frame: Baseline, 8-weeks
Modified Ashworth Scale for Upper Extremity
This is an impairment scale to measure muscle spasticity or tone in response to passive lengthening of a muscle. It requires the participant to lay supine while study staff, the blinded assessor/therapist, passively moves a joint to lengthen a muscle over a joint's full range of motion over approximately 1 second, or approximately at the speed of gravity. Each joint/muscle tested may be tested up to three times. The scale rates resistance to passive movement from 0 (no increase in tone) to 4 (joint fixed in flexion or extension). For this study, only the upper limb will be tested as part of the protocol.
Time frame: Baseline, 8-weeks
Capabilities of Upper Extremity Questionnaire CUE-Q
The CUE-Q is a 32-item questionnaire that evaluates functional limitations of the hands and arms using a scale of perceived difficulty from 0 (unable) - 4 (no difficulty). Activities inquired about include reaching, lifting objects, pulling/sliding objects, holding small objects like coins, etc. This may take 5-15 minutes to administer.
Time frame: Baseline, 8-weeks
Inpatient Rehabilitation Facility Patient Assessment Instrument IRF-PAI (Section GG codes)
This assessment is designed solely for use during inpatient rehabilitation; it replaced the previous use of the FIM measure for inpatient rehabilitation. For this outcome, assessments will be completed by VA clinical therapist(s) who will categorize typical function over a 3-day admission period and during the final three days prior to discharge. This assessment categorizes functional level from 01 (dependent) to 6 (independent). For this study, this assessment will be completed as a portion of clinical assessment, and will include observation of specific functional activities as deemed appropriate \& safe for clinical assessment including but not limited to: Self-care (upper body dressing, bathing,, toileting, oral hygiene, eating, etc), mobility ((rolling, sit to lying, lying to sitting edge of bed, sit to stand, chair to chair transfer, toilet transfer, walking various distances, stairs, wheeled mobility, etc), bowel and bladder continence, and health history (falls, pain, etc).
Time frame: Baseline, 8-weeks
PROMIS Pain Intensity and Pain Interference Scales
Promis Pain Intensity and Interference scales are short form assessments using a Likert scale addressing levels of pain or pain interference from 1 (not at all/never) - 7 (very much/always). These scales would take less than 10 minutes to complete.
Time frame: Baseline, 8-weeks
Spinal Cord Injury Quality of Life - Resilience SCI-QOL
This assessment focused on measuring quality of life (QOL) across physical, emotional and global health domains using a Likert scale with ratings from 1 (lowest frequency, or never) to 5 (highest frequency or always). This scale is sometimes called the NeuroQOL, and has been updated to be structured like the PROMIS measures where it can be completed via paper forms, short forms, or a computer adaptive testing on a tool such as REDcap. The adaptive testing can take as little as 10 minutes and provides a T-score across a normalized scoring distribution of 100, where the mean is 50.
Time frame: Baseline, 8-weeks
Plan to share: Yes — All IPD that underlie results in a publication
Supporting information: Statistical analysis plan, Analytic code
Time frame: The CRADA associated with this research indicates that the IPD and supporting information can be released after 180 days upon completion of the CRADA. We anticipate having the IPD and supporting information available after that period.
Access criteria: The PI and Statistician will review requests.
Started Jun 2026 (actual). Primary completion is estimated for Jun 2030, 47 months after the start.
Of 790 non-industry interventional studies with no phase under Spinal Cord Injuries, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 65. This study's planned 47 months is above that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Center for Veterans Research and Education