An interventional study of Exoskeleton-Assisted Walking (EAW) and Sham Transcutaneous Spinal Cord Stimulation (tSCS) in Spinal Cord Injury, sponsored by VA Office of Research and Development. Not yet recruiting at 2 sites in United States. Open to participants aged 21 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
Immobilization following spinal cord injury (SCI) results in muscle and bone loss below the level of injury, which ultimately predisposes to fracture at several sites throughout the legs and can lead to several medical complications that can devastate quality of life. There is a scarcity of research that has successfully implemented rehabilitation and/or exercise training interventions to preserve the musculoskeletal system during the acute phase SCI, or possibly reverse the muscle and bone loss that has already occurred in chronic SCI. This study will compare the effect of exoskeleton-assisted walking (EAW) training combined with transcutaneous spinal cord stimulation (tSCS) (EAW + active tSCS), to that of EAW + sham tSCS, on measures of muscle and bone health in a cohort of chronically injured motor incomplete SCI. A successful outcome would expand treatment options to improve musculoskeletal health over the lifetime.
Background: Immobilization results in bone loss that predisposes to osteoporosis and fracture, which may be complicated by non-union, infection, and deep venous thrombosis. Reduced muscular contraction after SCI and the elevated release of cortisol contribute to a catabolic state, resulting in a loss of lean tissue mass (LTM) below the level of lesion. Six months after motor-complete SCI, the average muscle cross-sectional area (CSA) significantly decreases at the quadriceps, hamstrings, and hip adductors (14-16%), and 12% and 24% at the soleus and gastrocnemius, respectively. Following SCI, the quadricep muscles generate less total force and force per unit area when evoked by surface electrode electrical stimulation. This loss of muscle CSA and strength in the lower extremities limits the ability to stand, ambulate, and preserve bone - even if neural regenerative strategies could be implemented in the future. In addition to the marked skeletal muscle atrophy, persons with non-ambulatory motor-complete SCI also experience a precipitous loss of bone mineral content (BMC) and bone mineral density (BMD) by as much as 1% per week below the level of lesion. In individuals with motor-incomplete lesions who have not reached their ambulatory potential, there is still considerable bone loss due to immobilization that can reach the fracture threshold years after injury. This rapid bone loss during the first two years after SCI results in volumetric BMD (vBMD) at the DF and PT decreasing by \~ 50% and 26% at the trabecular and cortical compartments, respectively. During the chronic phase of SCI bone loss continues more slowly throughout the individuals lifetime. This loss in muscle and bone places individuals with SCI at high risk for fragility fracture. More than 50% of individuals with SCI experience a fragility fracture over the course of their lifetimes. Objectives: Aim 1: To compare the effects of 108 sessions of EAW + sham tSCS versus EAW + active tSCS on the muscle-bone unit in wheelchair-dependent chronic SCI participants.Aim 2 (exploratory): To determine the acute time-course responses for serum/plasma biomarkers of bone resorption and formation, muscle contractile activity, and the mRNA profiles of circulating exosomes collected prior to (time 0), and again 30, 60, 120, 180, minutes and 24, and 48 hours following an acute session of both the EAW + active tSCS and EAW + sham tSCS training interventions. Setting: Participant enrollment, the clinical trial intervention (EAW + sham tSCS versus EAW + active tSCS), EMG data collection, dual energy X-ray absorptiometry (DXA), peripheral quantitative computed tomography (pQCT), magnetic resonance imaging (MRI) to measure the cross-sectional area of the mid-thigh, and the time-course responses for serum/plasma biomarkers of bone resorption and formation and muscle contractile activity will be performed at the Kessler Foundation and the James J. Peters VA Medical Center.Design: After meeting eligibility criteria, wheelchair users with chronic SCI will be block randomized into the EAW + active tSCS group or the EAW + sham tSCS group (n=12 in each group). Both groups will receive 60 minutes of EAW overground training per session for a total of 108 sessions (3 X week for 36 weeks). In addition to the EAW training, the EAW + active tSCS group will receive simultaneous lumbosacral tSCS targeted to activate the locomotor central pattern generator. Participants: Twenty-four participants (12 participants/group) with SCI will be recruited over a 4-year period and randomly assigned to an EAW + sham tSCS or EAW + active tSCS group. At the end of the first year, approximately 3 participants will have completed the protocol. Outcome measures: At baseline, the investigators will perform imaging to measure bone density and strength, surface EMG to assess muscle contractility, and a time-course response for serum muscle and bone biomarkers following an acute bout of EAW. The investigators will capture these same data again after \~54 training sessions (mid-point), and after 108 training sessions (month 9 timepoint). In addition, MRI of both legs for muscle CSA will be performed at the baseline and month 9 time point.
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's planned enrollment of 24 is close to the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.
Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.
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Inclusion Criteria:
Anthropometric compatibility with the EAW device:
Exclusion Criteria:
Exclusion Criteria from MRI Safety Screening:
Body metal, including any of the following:
The EAW + active tSCS group will receive simultaneous lumbosacral tSCS while simultaneously performing EAW.
Device: Exoskeleton-Assisted Walking (EAW) · Device: Active Transcutaneous Spinal Cord Stimulation (tSCS)
The EAW + sham tSCS group will receive simultaneous lumbosacral sham tSCS while simultaneously performing EAW. Participants in both groups will receive 60 minutes of EAW + sham tSCS overground training per session for a total of 108 sessions (3 X week for 36 weeks).
Device: Exoskeleton-Assisted Walking (EAW) · Device: Sham Transcutaneous Spinal Cord Stimulation (tSCS)
Participants will perform EAW will for 60 minutes per session for a total of 108 sessions (3 X week for 36 weeks).
The lumbosacral tSCS electrical signal is set too low to have any biological effect while simultaneously performing EAW.
Participants in the active tSCS group will receive simultaneous lumbosacral tSCS while simultaneously performing EAW.
Muscle cross sectional area of the mid-thigh
EAW + active tSCS will increase muscle cross sectional area of the mid-thigh more than EAW + sham tSCS.
Time frame: Obtained prior to starting the study at enrollment (baseline) and again at the 9 month study time point (post intervention).
Bone Strength at the Distal Femur and Proximal Tibia
EAW + active tSCS will increase bone strength at the distal femur and proximal tibia more than EAW + sham tSCS.
Time frame: Obtained prior to starting the study at enrollment (baseline), at the 4.5 month study time point (mid-point), with a final measurement completed at the 9 month study time point (post intervention).
Muscle and Bone Serum and Plasma Biomarker Time-Course Response
An intravenous line will be placed to draw serial serum and plasma samples prior to (time 0), and again 30, 60, 120, 180, minutes and 24, and 48 hours following an acute session of either an EAW + sham tSCS or an EAW + active tSCS training intervention depending on that participant's group assignment.
Time frame: Obtained prior to starting the study at enrollment (baseline), at the 4.5 month study time point (mid-point), with a final measurement completed at the 9 month study time point (post intervention).
Seated and Supine Electromyography (EMG) assessments of Muscle Activation
Surface EMG data will be collected from muscles in each leg to assess surface EMG amplitudes of these muscles during attempts at volitional knee extension and flexion and ankle plantar- and dorsi-flexion using surface sensors. Furthermore, the resting EMG protocol will be performed to determine the individualized mapping to determine the minimum tSCS intensity required to evoke a motor evoked potential (MEP).
Time frame: Obtained prior to starting the study at enrollment (baseline), at the 4.5 month study time point (mid-point), with a final measurement completed at the 9 month study time point (post intervention).
Plan to share: No
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