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Non Traumatic Spinal Cord InjuryNCT07911657

Functional Electrical Stimulation vs Transcutaneous Stimulation in Patients With Subacute Spinal Cord Injury

A study testing RTI Xcite and ExaStim in people with Non Traumatic Spinal Cord Injury and Sub-Acute Rehabilitation, run by Center for Veterans Research and Education at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
RTI Xcite and ExaStim
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
18 Jun 2026to 1 Jun 2030
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

  • • Veterans admitted to the Minneapolis VA Health Care System's (MVAHCS) SCI inpatient unit for sub-acute rehabilitation following non-traumatic cervical SCI.
  • Veterans are eligible for enrollment within 90 days of the onset of their spinal cord injury.
  • Non-traumatic SCI, level T2 or above; AIS A,B,C,D.
  • Age 18+.

Who cannot join

  • • Study clinicians determine that the veteran would likely not benefit from FES.
  • Open wounds where electrodes would be placed.
  • Cognitive impairments identified during the consent process indicating a veteran's Inability to comprehend essential information about the study.
  • Contraindications to electrical stimulation (pacemaker, defibrillator, pregnancy, active tissue infection in area of stimulation).
  • Active implanted medical device for electrical stimulation.
  • Other internal metallic objects of unknown or foreign origin (unidentifiable surgical implants, shrapnel, bullet fragments, etc.)
Show all 18Show fewer
  • Acute medical conditions under active treatment that would contraindicate standard rehabilitation." History of a non-SCID related neurological condition (stroke, brain injury, etc.) impacting upper extremity.
  • Uncontrolled, severe autonomic dysreflexia.
  • Need for ventilator support.
  • Inability to participate in therapy session >60 minutes.
  • Botulinum toxin injections to the upper limb in prior 3 months.
  • BMI > 40.0 (morbid obesity).
  • Allergy to hydrogel, silicone, latex or other product materials.
  • Uncontrolled cardiopulmonary disease.
  • Uncontrolled epilepsy or seizures.
  • Unmanaged depression, psychiatric disorders or ongoing substance abuse.
  • Participation in another clinical trial that may interfere with this study.
  • Pregnancy is contra-indicated for both TSS and FES. Women of childbearing years will be excluded as the enrollment timeline won't allow time for pregnancy testing.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Katherine Metcalf contact

612-467-3538

Katherine.Metcalf@va.gov

United States1 site, 1 recruiting

  • Minneapolis VA Health Care Systems

    Minneapolis, Minnesota, 55417

    Jennifer L Robb, PhD, (763) 346-9826, Jennifer.Robb2@va.gov

    John M Looft, PhD

    Recruiting

Other trials in United States

About this study

Official title: Comparison of Traditional Functional Electrical Stimulation to Transcutaneous Stimulation on Upper Extremity Outcomes in Patients With Subacute Spinal Cord Injury

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.

Read the detailed description

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.

Being tested
RTI Xcite, ExaStim
Keywords
Cervical spinal cord injury, Non-traumatic spinal cord injury, Veterans, Upper extremity function, Sub-acute rehabilitation, Functional electrical stimulation, Transcutaneous spinal stimulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RTI XciteDevice

    Functional electrical stimulation

  • ExaStimDevice

    Transcutaneous spinal stimulation

Study groups in NCT07911657
Study groupRoleWhat they receive
Functional electrical stimulationActive comparatorRTI Xcite
Receives: Device: RTI Xcite
Transcutaneous spinal stimulationExperimentalExaStim
Receives: Device: ExaStim

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.)

    Measured: Baseline, 4-week, 8-week

Secondary outcomes (3)

  1. 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).

    Measured: Baseline, 8-weeks

  2. 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.

    Measured: Baseline, 8-weeks

  3. 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.

    Measured: Baseline, 8-weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2026
  2. Study start18 Jun 2026
  3. Primary completion1 Jun 2030 (estimated)
  4. Study completion1 Jun 2030 (estimated)

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07911657
Sponsor's protocol ID
1904131
Status last verified
Oct 2026
First submitted
27 Oct 2026
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: All IPD that underlie results in a publication

Publications

  • Zhang F, Momeni K, Ramanujam A, Ravi M, Carnahan J, Kirshblum S, Forrest GF. Cervical Spinal Cord Transcutaneous Stimulation Improves Upper Extremity and Hand Function in People With Complete Tetraplegia: A Case Study. IEEE Trans Neural Syst Rehabil Eng. 2020 Dec;28(12):3167-3174. doi: 10.1109/TNSRE.2020.3048592. Epub 2021 Jan 28.

    PubMed 33382659

  • Verma N, Oh J, Bedoy E, Chetty N, Steele AG, Park SJ, Guerrero JR, Faraji AH, Weber D, Sayenko DG. Transcutaneous stimulation of the cervical spinal cord facilitates motoneuron firing and improves hand-motor function after spinal cord injury. J Neurophysiol. 2025 Jul 1;134(1):128-143. doi: 10.1152/jn.00422.2024. Epub 2025 Jun 10.

    PubMed 40493910

  • Taylor C, McHugh C, Mockler D, Minogue C, Reilly RB, Fleming N. Transcutaneous spinal cord stimulation and motor responses in individuals with spinal cord injury: A methodological review. PLoS One. 2021 Nov 18;16(11):e0260166. doi: 10.1371/journal.pone.0260166. eCollection 2021.

    PubMed 34793572

  • Moritz C, Field-Fote EC, Tefertiller C, van Nes I, Trumbower R, Kalsi-Ryan S, Purcell M, Janssen TWJ, Krassioukov A, Morse LR, Zhao KD, Guest J, Marino RJ, Murray LM, Wecht JM, Rieger M, Pradarelli J, Turner A, D'Amico J, Squair JW, Courtine G. Non-invasive spinal cord electrical stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial. Nat Med. 2024 May;30(5):1276-1283. doi: 10.1038/s41591-024-02940-9. Epub 2024 May 20.

    PubMed 38769431

  • Molinares DM, Gater DR, Daniel S, Pontee NL. Nontraumatic Spinal Cord Injury: Epidemiology, Etiology and Management. J Pers Med. 2022 Nov 8;12(11):1872. doi: 10.3390/jpm12111872.

    PubMed 36579590

  • Liu GF, Lu K, Mogg R, Mallick M, Mehrotra DV. Should baseline be a covariate or dependent variable in analyses of change from baseline in clinical trials? Stat Med. 2009 Sep 10;28(20):2509-30. doi: 10.1002/sim.3639.

    PubMed 19610129

  • Lakens D. Calculating and reporting effect sizes to facilitate cumulative science: a practical primer for t-tests and ANOVAs. Front Psychol. 2013 Nov 26;4:863. doi: 10.3389/fpsyg.2013.00863.

    PubMed 24324449

  • Inanici F, Brighton LN, Samejima S, Hofstetter CP, Moritz CT. Transcutaneous Spinal Cord Stimulation Restores Hand and Arm Function After Spinal Cord Injury. IEEE Trans Neural Syst Rehabil Eng. 2021;29:310-319. doi: 10.1109/TNSRE.2021.3049133. Epub 2021 Mar 2.

    PubMed 33400652

  • Inanici F, Samejima S, Gad P, Edgerton VR, Hofstetter CP, Moritz CT. Transcutaneous Electrical Spinal Stimulation Promotes Long-Term Recovery of Upper Extremity Function in Chronic Tetraplegia. IEEE Trans Neural Syst Rehabil Eng. 2018 Jun;26(6):1272-1278. doi: 10.1109/TNSRE.2018.2834339.

    PubMed 29877852

  • Ge L, Arul K, Ikpeze T, Baldwin A, Nickels JL, Mesfin A. Traumatic and Nontraumatic Spinal Cord Injuries. World Neurosurg. 2018 Mar;111:e142-e148. doi: 10.1016/j.wneu.2017.12.008. Epub 2017 Dec 15.

    PubMed 29253698

  • Freyvert Y, Yong NA, Morikawa E, Zdunowski S, Sarino ME, Gerasimenko Y, Edgerton VR, Lu DC. Engaging cervical spinal circuitry with non-invasive spinal stimulation and buspirone to restore hand function in chronic motor complete patients. Sci Rep. 2018 Oct 19;8(1):15546. doi: 10.1038/s41598-018-33123-5.

    PubMed 30341390

  • Clifton L, Clifton DA. The correlation between baseline score and post-intervention score, and its implications for statistical analysis. Trials. 2019 Jan 11;20(1):43. doi: 10.1186/s13063-018-3108-3.

    PubMed 30635021

  • Chandrasekaran S, Bhagat NA, Ramdeo R, Ebrahimi S, Sharma PD, Griffin DG, Stein A, Harkema SJ, Bouton CE. Targeted transcutaneous spinal cord stimulation promotes persistent recovery of upper limb strength and tactile sensation in spinal cord injury: a pilot study. Front Neurosci. 2023 Jul 7;17:1210328. doi: 10.3389/fnins.2023.1210328. eCollection 2023.

    PubMed 37483349

  • Chan AW, Boutron I, Hopewell S, Moher D, Schulz KF, Collins GS, Tunn R, Aggarwal R, Berkwits M, Berlin JA, Bhandari N, Butcher NJ, Campbell MK, Chidebe RCW, Elbourne DR, Farmer AJ, Fergusson DA, Golub RM, Goodman SN, Hoffmann TC, Ioannidis JPA, Kahan BC, Knowles RL, Lamb SE, Lewis S, Loder E, Offringa M, Ravaud P, Richards DP, Rockhold FW, Schriger DL, Siegfried NL, Staniszewska S, Taylor RS, Thabane L, Torgerson DJ, Vohra S, White IR, Hrobjartsson A. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. BMJ. 2025 Apr 28;389:e081477. doi: 10.1136/bmj-2024-081477.

    PubMed 40294953

  • Alito A, Filardi V, Fama F, Bruschetta D, Ruggeri C, Basile G, Stancanelli L, D'Amico C, Bianconi S, Tisano A. Traumatic and non-traumatic spinal cord injury: Demographic characteristics, neurological and functional outcomes. A 7-year single centre experience. J Orthop. 2021 Nov 20;28:62-66. doi: 10.1016/j.jor.2021.11.007. eCollection 2021 Nov-Dec.

    PubMed 34880567

Questions about this trial

What is this clinical trial studying?

A study testing RTI Xcite and ExaStim in people with Non Traumatic Spinal Cord Injury and Sub-Acute Rehabilitation, run by Center for Veterans Research and Education 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 4 inclusion and 18 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 3 Nov 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 Katherine Metcalf (612-467-3538, Katherine.Metcalf@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Capabilities of Upper Extremity Test (CUE-T) (time frame: Baseline, 4-week, 8-week). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07911657, which also lists 15 linked publications.

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 3 Nov 2026.

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