An interventional study of Standing transspinal stimulation followed by robotic gait training and Lying transspinal stimulation followed by robotic gait training in Spinal Cord Injuries, Paraplegia, Spinal and Tetraplegia/Tetraparesis, sponsored by City University of New York. Completed at 2 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by City University of New York · Not applicable, Interventional, and Treatment
Locomotor training is often used with the aim to improve corticospinal function and walking ability in individuals with Spinal Cord Injury. Excitingly, the benefits of locomotor training may be augmented by noninvasive electrical stimulation of the spinal cord and enhance motor recovery at SCI. This study will compare the effects of priming locomotor training with high-frequency noninvasive thoracolumbar spinal stimulation. In people with motor-incomplete SCI, a series of clinical and electrical tests of brain and spinal cord function will be performed before and after 40 sessions of locomotor training where spinal stimulation is delivered immediately before either lying down or during standing.
Spinal cord injury (SCI) greatly impairs standing and walking ability, which severely compromises daily living activities. While these deficits are partially improved by locomotor training, even after multiple training sessions, abnormal muscle activity and coordination still persist. Thus, locomotor training alone cannot fully optimize the neuronal plasticity required to strengthen the synapses connecting the brain, spinal cord, and local circuits. As such, treatment interventions that effectively promote neuromodulation of spinal locomotor networks and strengthen neural connectivity of the injured human spinal cord in combination with physical rehabilitation are greatly needed. It is proposed that transcutaneous spinal cord (transspinal) stimulation as a method to synergistically 'prime' the nervous system to better respond to locomotor training. Transspinal stimulation alters motoneuron excitability over multiple spinal segments, a pre-requisite for functioning descending and local inputs. Importantly, whether concurrent treatment with transspinal stimulation and locomotor training maximizes motor recovery after SCI is unknown. The goal of this clinical trial is to use high frequency (30 Hz) transspinal stimulation to prime locomotor training and ultimately improve standing, walking, and overall function in individuals with chronic incomplete SCI (iSCI). Forty-five individuals with iSCI will undergo 40 sessions of body weight-supported step training primed with high-frequency transspinal stimulation. Participants will be randomized to receive transspinal stimulation during standing (real or sham) or while supine (real). Aim 1 evaluates how priming locomotor training with high-frequency transspinal stimulation in SCI alters corticomotoneuronal connectivity strength, as indicated by motor evoked potentials recorded from the legs.
Aim 2 evaluates how priming locomotor training with high-frequency transspinal stimulation in iSCI affects reorganization and appropriate engagement of spinal neuronal circuits. Finally, Aim 3 evaluates activity-based motor function, ability to stand and walk, and quality of life. These results will support the notion that tonic high-frequency transspinal stimulation strengthens corticomotoneuronal connectivity and improves spinal circuit organization through posture-dependent corticospinal neuroplasticity. It is anticipated that the information gained from this mechanistic clinical trial will greatly impact clinical practice. This is because in real-world clinical settings, noninvasive transspinal stimulation can be more easily and widely implemented than invasive epidural stimulation.
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Transspinal tonic stimulation of the thoracolumbar region will be delivered at a frequency of 30 Hz during standing with as needed body weight support (BWS) in a standing frame or in the Lokomat to ensure safety.
Combination Product: Standing transspinal stimulation followed by robotic gait training
Transspinal tonic stimulation will be delivered at a frequency of 30 Hz while lying supine.
Combination Product: Lying transspinal stimulation followed by robotic gait training
One sham group will be receiving transspinal stimulation during standing at an intensity where sensation is absent.
Other: Standing sham transspinal stimulation followed by robotic gait training
Fifteen people with spinal cord injury will receive 40 daily sessions of 30 minutes of non-invasive high frequency (e.g. 30 Hz) transcutaneous transspinal stimulation during standing followed by 30 minutes of assisted stepping robotic gait training. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.
Also known as: Standing transspinal stimulation
Fifteen people with spinal cord injury will receive 40 daily sessions of 30 minutes of non-invasive high frequency (e.g. 30 Hz) transcutaneous transspinal stimulation while lying supine on a therapy table followed by 30 minutes of assisted stepping robotic gait training. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.
Also known as: Lying transspinal stimulation
Fifteen people with spinal cord injury will receive 40 daily sessions of 30 minutes of sham transspinal stimulation during standing at an intensity where sensation is absent followed by 30 minutes of robotic gait training. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.
Also known as: Robotic gait training
Plasticity of Spinal Neuronal Networks - Homosynaptic Depression
Soleus H-reflexes following posterior tibial nerve stimulation with a 1-ms monophasic pulse were recorded with subjects seated and stimuli delivered every 1 s (1.0 Hz), 3 s (0.33 Hz), 5 s (0.2 Hz), 8 s (0.125 Hz), and 10s (0.1 Hz). Results for each interval vs 0.1 Hz shown.
Time frame: 4-6 months
Plasticity of Spinal Neuronal Networks - Presynaptic Inhibition
Presynaptic inhibition was assessed with a conditioning pulse train of 4 pulses with 9 ms duration, delivered to the CPN at the C-T intervals of 20, 60, or 100 ms. These C-T intervals were selected because the reflex inhibition produced at the intermediate C-T intervals is predominantly presynaptic. The stimulus to the CPN was delivered at 1.27 ± 0.12 (21.8 ± 10.1 mA) and 1.4 ± 0.28 (21.8 ± 10.1 mA) TA motor threshold before and after treatment, respectively. Control and conditioned soleus H-reflexes were randomly recorded across the C-T intervals tested, and 15 H-reflexes were recorded at each C-T interval. For each participant at each timepoint, amplitudes across the 15 H-reflexes per C-T interval were averaged. Results are listed for each C-T interval, pre- and post-intervention.
Time frame: 4-6 months
Plasticity of Spinal Neuronal Networks - Reciprocal Inhigition
To assess restoration of reciprocal Ia inhibition, soleus H-reflexes were recorded following common peroneal nerve (CPN) stimulation at short conditioning-test (C-T) intervals of 0, 1, 2, 3, and 4 ms. The stimulus to the CPN was delivered at 1.27 ± 0.12 (21.8 ± 10.1 mA) and 1.4 ± 0.28 (21.8 ± 10.1 mA) TA motor threshold before and after treatment, respectively. Control and conditioned soleus H-reflexes were randomly recorded across the C-T intervals tested, and 15 H-reflexes were recorded at each C-T interval. For each participant at each timepoint, amplitudes across the 15 H-reflexes per C-T interval were averaged. Results are listed for each C-T interval, pre- and post-intervention.
Time frame: 4-6 months
Plasticity of Corticospinal Networks
Neurophysiological measurements assessing changes in corticospinal excitability from the interventions by recording responses to single-pulse transcranial magnetic stimulation (TMS) at rest and during robotic-assisted stepping. The tibialis anterior resting motor threshold (RMT) was established and corresponded to the lowest TMS maximal stimulator output that induced reproducible evoked potentials of at least \~50 µV in 4 out of 5 consecutive single TMS pulses. RMTs (percentage of maximal stimulator output) are shown pre- and post-intervention.
Time frame: 4-6 months
Ambulatory Function
Change in 10-meter timed test (seconds required to complete 10-meter walk) between baseline and post-intervention. Fewer seconds means faster (better) gait.
Time frame: 4-6 months
Balance
Changes in Berg Balance Scale score between baseline and post-intervention. Scale scores between 0 and 56. Higher scores mean better balance.
Time frame: 4-6 months
Autonomic Function
SCIM III Bladder and Bowel management subscores Bladder subscore rated 0-15 (higher means better bladder function). Bowel subscore rated 0-10 (higher means better bowel function).
Time frame: 4-6 months
Participants with SCI were recruited from various sources: Each site's existing databases of past research participants; people with SCI seen clinically at the James J. Peters VA Medical Center and Mount Sinai Medical Center; via flyers and webpage notices; and through various tabling events at local expositions and gyms that cater to people with SCI.
| Milestone | Real Transspinal Stimulation Delivered During Standing Followed by Locomotor Training | Real Transspinal Stimulation Delivered While Lying Supine Followed by Locomotor Training | Sham Transspinal Stimulation Delivered During Standing Followed by Locomotor Training |
|---|---|---|---|
| Started | 4 | 5 | 5 |
| Completed | 4 | 5 | 5 |
| Not completed | 0 | 0 | 0 |
Soleus H-reflexes following posterior tibial nerve stimulation with a 1-ms monophasic pulse were recorded with subjects seated and stimuli delivered every 1 s (1.0 Hz), 3 s (0.33 Hz), 5 s (0.2 Hz), 8 s (0.125 Hz), and 10s (0.1 Hz). Results for each interval vs 0.1 Hz shown.
| Percent H-reflex amplitude | Real Transspinal Stimulation Delivered During Standing Followed by Locomotor Training | Real Transspinal Stimulation Delivered While Lying Supine Followed by Locomotor Training | Sham Transspinal Stimulation Delivered During Standing Followed by Locomotor Training |
|---|---|---|---|
| 1.0 vs 0.1 Hz, pre-training (baseline) | 53.0 ± 16.1 | 63.9 ± 31.7 | 56.0 ± 14.2 |
| 1.0 vs 0.1 Hz, post-training (4-6 months) | 36.5 ± 15.9 | 54.1 ± 18.1 | 53.3 ± 18.6 |
| 0.33 Hz vs 0.1 Hz, pre-training (baseline) | 93.3 ± 28.0 | 84.3 ± 16.4 | 71.3 ± 15.2 |
| 0.33 Hz vs 0.1 Hz, post-training (4-6 months) | 82.0 ± 19.9 | 75.7 ± 9.8 | 77.3 ± 11.9 |
| 0.2 Hz vs 0.1 Hz, pre-training (baseline) | 97.9 ± 26.0 | 94.2 ± 15.0 | 101.6 ± 35.8 |
| 0.2 Hz vs 0.1 Hz, post-training (4-6 months) | 90.8 ± 15.4 | 85.6 ± 13.7 | 98.1 ± 10.6 |
| 0.125 Hz vs 0.1 Hz, pre-training (baseline) | 102.8 ± 20.1 | 102.7 ± 21.3 | 110.5 ± 32.4 |
| 0.125 Hz vs 0.1 Hz, post-training (4-6 months) | 99.6 ± 17.8 | 94.4 ± 12.8 | 94.5 ± 10.0 |
Presynaptic inhibition was assessed with a conditioning pulse train of 4 pulses with 9 ms duration, delivered to the CPN at the C-T intervals of 20, 60, or 100 ms. These C-T intervals were selected because the reflex inhibition produced at the intermediate C-T intervals is predominantly presynaptic. The stimulus to the CPN was delivered at 1.27 ± 0.12 (21.8 ± 10.1 mA) and 1.4 ± 0.28 (21.8 ± 10.1 mA) TA motor threshold before and after treatment, respectively. Control and conditioned soleus H-reflexes were randomly recorded across the C-T intervals tested, and 15 H-reflexes were recorded at each C-T interval. For each participant at each timepoint, amplitudes across the 15 H-reflexes per C-T interval were averaged. Results are listed for each C-T interval, pre- and post-intervention.
| Conditioned vs unconditioned H-reflex % | Real Transspinal Stimulation Delivered During Standing Followed by Locomotor Training | Real Transspinal Stimulation Delivered While Lying Supine Followed by Locomotor Training | Sham Transspinal Stimulation Delivered During Standing Followed by Locomotor Training |
|---|---|---|---|
| Pre-intervention, 60ms (baseline) | 112.8 ± 14.6 | 100.5 ± 15.2 | 94.4 ± 28.9 |
| Post-intervention, 60ms (4-6 months) | 62.8 ± 30.4 | 77.1 ± 46.3 | 57.4 ± 25.9 |
| Pre-intervention, 20 ms (baseline) | 94.1 ± 15.8 | 95.0 ± 30.3 | 109.4 ± 41.3 |
| Post-intervention, 20 ms (4-6 months) | 90.3 ± 18.9 | 95.4 ± 22.2 | 147.3 ± 74.3 |
| Pre-intervention, 100 ms (baseline) | 79.9 ± 37.3 | 80.7 ± 42.6 | 104.3 ± 37.1 |
| Post-intervention, 100 ms (4-6 months) | 57.7 ± 61.2 | 47.2 ± 45.1 | 45.9 ± 21.5 |
Change in 10-meter timed test (seconds required to complete 10-meter walk) between baseline and post-intervention. Fewer seconds means faster (better) gait.
| seconds | Real Transspinal Stimulation Delivered During Standing Followed by Locomotor Training | Real Transspinal Stimulation Delivered While Lying Supine Followed by Locomotor Training | Sham Transspinal Stimulation Delivered During Standing Followed by Locomotor Training |
|---|---|---|---|
| Ambulatory Function | -2.0 (-2.7 to -1.2) | 2.6 (-0.8 to 9) | -.2 (-12.7 to 14) |
Changes in Berg Balance Scale score between baseline and post-intervention. Scale scores between 0 and 56. Higher scores mean better balance.
| units on a scale | Real Transspinal Stimulation Delivered During Standing Followed by Locomotor Training | Real Transspinal Stimulation Delivered While Lying Supine Followed by Locomotor Training | Sham Transspinal Stimulation Delivered During Standing Followed by Locomotor Training |
|---|---|---|---|
| Balance | 2 (-2 to 6) | -0.33 (-1 to 0) | 5.67 (0 to 16) |
SCIM III Bladder and Bowel management subscores Bladder subscore rated 0-15 (higher means better bladder function). Bowel subscore rated 0-10 (higher means better bowel function).
| units on subscale | Real Transspinal Stimulation Delivered During Standing Followed by Locomotor Training | Real Transspinal Stimulation Delivered While Lying Supine Followed by Locomotor Training | Sham Transspinal Stimulation Delivered During Standing Followed by Locomotor Training |
|---|---|---|---|
| Bladder subscore, pre-intervention (baseline) | 15 ± 0 | 11.5 ± 3.5 | 5.0 ± 8.7 |
| Bladder subscore, post-intervention (4-6 months) | 15 ± 0 | 12.0 ± 4.2 | 5.0 ± 10.6 |
| Bowel subscore, pre-intervention (baseline) | 10 ± 0 | 7.5 ± 3.5 | 5 ± 3.5 |
| Bowel subscore, post-intervention (4-6 months) | 10 ± 0 | 9 ± 1.4 | 5 ± 3.5 |
To assess restoration of reciprocal Ia inhibition, soleus H-reflexes were recorded following common peroneal nerve (CPN) stimulation at short conditioning-test (C-T) intervals of 0, 1, 2, 3, and 4 ms. The stimulus to the CPN was delivered at 1.27 ± 0.12 (21.8 ± 10.1 mA) and 1.4 ± 0.28 (21.8 ± 10.1 mA) TA motor threshold before and after treatment, respectively. Control and conditioned soleus H-reflexes were randomly recorded across the C-T intervals tested, and 15 H-reflexes were recorded at each C-T interval. For each participant at each timepoint, amplitudes across the 15 H-reflexes per C-T interval were averaged. Results are listed for each C-T interval, pre- and post-intervention.
| Conditioned vs unconditioned H-reflex % | Real Transspinal Stimulation Delivered During Standing Followed by Locomotor Training | Real Transspinal Stimulation Delivered While Lying Supine Followed by Locomotor Training | Sham Transspinal Stimulation Delivered During Standing Followed by Locomotor Training |
|---|---|---|---|
| Pre-intervention, 1ms (baseline) | 102.7 ± 5.4 | 103.3 ± 17.3 | 103.4 ± 20.3 |
| Post-intervention, 1ms (4-6 months) | 101.3 ± 11.2 | 85.8 ± 18.6 | 89.2 ± 12.3 |
| Pre-intervention, 2ms (baseline) | 101.9 ± 14.5 | 84.7 ± 13.2 | 104.6 ± 25.5 |
| Post-intervention, 2ms (4-6 months) | 99.5 ± 14.0 | 78.8 ± 7.4 | 83.0 ± 165 |
| Pre-intervention, 3ms (baseline) | 92.1 ± 12.9 | 92.3 ± 11.3 | 104.2 ± 22.7 |
| Post-intervention, 3ms (4-6 months) | 101.9 ± 13.1 | 77.8 ± 23.9 | 84.7 ± 14.4 |
| Pre-intervention, 4ms (baseline) | 99.7 ± 12.5 | 89.8 ± 13.5 | 99.4 ± 26.4 |
| Post-intervention, 4ms (4-6 months) | 96.0 ± 7.8 | 78.9 ± 4.5 | 93.5 ± 16.5 |
Neurophysiological measurements assessing changes in corticospinal excitability from the interventions by recording responses to single-pulse transcranial magnetic stimulation (TMS) at rest and during robotic-assisted stepping. The tibialis anterior resting motor threshold (RMT) was established and corresponded to the lowest TMS maximal stimulator output that induced reproducible evoked potentials of at least \~50 µV in 4 out of 5 consecutive single TMS pulses. RMTs (percentage of maximal stimulator output) are shown pre- and post-intervention.
| % TMS maximal stimulator output | Real Transspinal Stimulation Delivered During Standing Followed by Locomotor Training | Real Transspinal Stimulation Delivered While Lying Supine Followed by Locomotor Training | Sham Transspinal Stimulation Delivered During Standing Followed by Locomotor Training |
|---|---|---|---|
| Pre-intervention (baseline) | 44.6 ± 17.6 | 49.5 ± 14.7 | 46.1 ± 10.0 |
| Post-intervention (4-6 months) | 33.8 ± 8.0 | 30.5 ± 17.5 | 41.2 ± 6.9 |
Collected over From enrollment through the final followup, up to 1 week.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Real Transspinal Stimulation Delivered During Standing Followed by Locomotor Training | 0/4 (0%) | 0/4 (0%) | 1/4 (25%) |
| Real Transspinal Stimulation Delivered While Lying Supine Followed by Locomotor Training | 0/5 (0%) | 0/5 (0%) | 3/5 (60%) |
| Sham Transspinal Stimulation Delivered During Standing Followed by Locomotor Training | 0/5 (0%) | 0/5 (0%) | 2/5 (40%) |
| Event | Real Transspinal Stimulation Delivered During Standing Followed by Locomotor Training | Real Transspinal Stimulation Delivered While Lying Supine Followed by Locomotor Training | Sham Transspinal Stimulation Delivered During Standing Followed by Locomotor Training |
|---|---|---|---|
| AbrasionSkin and subcutaneous tissue disorders | 1/4 | 2/5 | 2/5 |
| UTIRenal and urinary disorders | 0/4 | 1/5 | 0/5 |
| COVIDInfections and infestations | 0/4 | 1/5 | 0/5 |
| fecal incontinenceGastrointestinal disorders | 0/4 | 1/5 | 0/5 |
| Age, Continuous(Years) | Real Transspinal Stimulation Delivered During Standing Followed by Locomotor Training | Real Transspinal Stimulation Delivered While Lying Supine Followed by Locomotor Training | Sham Transspinal Stimulation Delivered During Standing Followed by Locomotor Training | Total |
|---|---|---|---|---|
| Mean | 44.5 ± 17.2 | 38.2 ± 13.4 | 45.2 ± 17.9 | 42.5 ± 15.3 |
| Sex: Female, Male(Participants) | Real Transspinal Stimulation Delivered During Standing Followed by Locomotor Training | Real Transspinal Stimulation Delivered While Lying Supine Followed by Locomotor Training | Sham Transspinal Stimulation Delivered During Standing Followed by Locomotor Training | Total |
|---|---|---|---|---|
| Female | 2 | 2 | 1 | 5 |
| Male | 2 | 3 | 4 | 9 |
| Race (NIH/OMB)(Participants) | Real Transspinal Stimulation Delivered During Standing Followed by Locomotor Training | Real Transspinal Stimulation Delivered While Lying Supine Followed by Locomotor Training | Sham Transspinal Stimulation Delivered During Standing Followed by Locomotor Training | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 0 | 3 |
| White | 3 | 3 | 3 | 9 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Real Transspinal Stimulation Delivered During Standing Followed by Locomotor Training | Real Transspinal Stimulation Delivered While Lying Supine Followed by Locomotor Training | Sham Transspinal Stimulation Delivered During Standing Followed by Locomotor Training | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 0 | 1 |
| Not Hispanic or Latino | 4 | 4 | 4 | 12 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Aug 2021 to primary completion in Dec 2024, 40 months.
Results were first posted in Aug 2026, 1 year 8 months after primary completion.
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 40 months is close to that.
Counting every sponsor, half of 839 studies reached it within 36 months; a quarter within 17 and three quarters within 64.
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City University of New York