Spinal Cord InjuryNCT07418398
Exoskeletal-assisted Walking Combined With Transcutaneous Spinal Cord Stimulation: Effect on Imaging and Serum Biomarkers of Skeletal Muscle Mass and Bone Strength.
A study testing Exoskeleton-Assisted Walking (EAW) and Active Transcutaneous Spinal Cord Stimulation (tSCS) in people with Spinal Cord Injury, run by VA Office of Research and Development at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 60 years
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Exoskeleton-Assisted Walking (EAW) and Active Transcutaneous Spinal Cord Stimulation (tSCS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Nov 2026to 1 Nov 2032
- 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 21 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Non-walkers with an SCI greater than 3 years post injury
- As measured by a member of the study staff, participants who have a lower extremity motor score greater or equal to 16 on the INSCSCI exam with an impairment grade of C or D
- Neurologic level of injury as determined by study staff between C5-T10 (completed at participant's screening)
- Capable of gripping Lofstrand crutches and/or a walker without assistance
- Wheelchair reliant 100% of the time
- Height is between 62 inches and 74 inches
Show all 10Show fewer
- Weight less than 220lbs
- Anthropometric compatibility with the EAW device:
- Thigh length between 14 and 19 in (36 and 48 cm)
- Shank length between 17 and 22 in (43 and 55 cm)
Who cannot join
- As determined by the study physician from the screening health exam, a history of fragility or traumatic fractures, unhealed fractures, and signs of swelling, bruising, and discoloration of the legs
- Current bone disease diagnosis (e.g., osteomyelitis, hyperparathyroidism)
- As determined by the study physician from the screening DXA study, a T-score at the total hip < -3.5 or aBMD of the knee (proximal tibia and/or distal femur) < 0.60 g/cm2 from the DXA screen
- Positive pregnancy test at any of the study intervention or assessment visits, or if female participants plan to become pregnant over the course of the study, they will be excluded or withdrawn (if already enrolled) from participation
- Currently in a gym/rehabilitation program performing ambulatory interventions such as EAW, as determined by the study staff
- Currently prescribed any medications that can affect muscle and/or bone metabolism, as determined by the study staff
Show all 18Show fewer
- Medically unsafe to receive an MRI scan
- Claustrophobia
- Baclofen pump
- Body metal, including any of the following:
- metal fragments or pieces in eyes or any other part of body
- pacemakers or other implanted electrical devices
- aneurysm clips (metal clips on wall of a large artery)
- metallic prostheses (metal pins and heart valves)
- internal hearing aids (cochlear implants)
- permanent eyeliner
- shrapnel fragments
- piercing that cannot be removed
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468-3904
Robert Jordan, (718) 584-9000 ext. 6020, robert.jordan@va.gov
Juan C Bandres, MD, (718) 584-9000 ext. 6667, juan.bandres2@va.gov
Kessler Foundation
West Orange, New Jersey, 07052
Gail F Forrest, PhD, 973-731-3900, gforrest@kesslerfoundation.org
Steven C Kirshblum, MD, 9737313900, skirshblum@kessler-rehab.com
About this study
Official title: Exoskeletal-assisted Walking Combined With Transcutaneous Spinal Cord Stimulation: Effect on Imaging and Serum Biomarkers of Skeletal Muscle Mass and Bone Strength
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.
Read the detailed description
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.
- Conditions
- Spinal Cord Injury
- Being tested
- Exoskeleton-Assisted Walking (EAW), Sham Transcutaneous Spinal Cord Stimulation (tSCS), Active Transcutaneous Spinal Cord Stimulation (tSCS)
- Keywords
- Spinal Cord Injury, Transcutaneous Spinal Cord Stimulation, Bone Mineral Density, Exoskeleton-Assisted Walking, Muscle Cross Sectional Area
- 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.
Exoskeleton-Assisted Walking (EAW)Device
Participants will perform EAW will for 60 minutes per session for a total of 108 sessions (3 X week for 36 weeks).
Sham Transcutaneous Spinal Cord Stimulation (tSCS)Device
The lumbosacral tSCS electrical signal is set too low to have any biological effect while simultaneously performing EAW.
Active Transcutaneous Spinal Cord Stimulation (tSCS)Device
Participants in the active tSCS group will receive simultaneous lumbosacral tSCS while simultaneously performing EAW.
| Study group | Role | What they receive |
|---|---|---|
| Exoskeleton-Assisted Walking (EAW) + active Transcutaneous Spinal Cord Stimulation (tSCS) | Experimental | The EAW + active tSCS group will receive simultaneous lumbosacral tSCS while simultaneously performing EAW. Receives: Device: Exoskeleton-Assisted Walking (EAW); Device: Active Transcutaneous Spinal Cord Stimulation (tSCS) |
| Exoskeleton-assisted walking (EAW) + sham Transcutaneous Spinal Cord Stimulation (tSCS) | Sham comparator | 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). Receives: Device: Exoskeleton-Assisted Walking (EAW); Device: Sham Transcutaneous Spinal Cord Stimulation (tSCS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Obtained prior to starting the study at enrollment (baseline) and again at the 9 month study time point (post intervention).
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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).
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2030 (estimated)
- Study completion1 Nov 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental: Exoskeleton-Assisted Walking (EAW) + active Transcutaneous Spinal Cord Stimulation (tSCS) Arm Description: The EAW + active tSCS group will receive simultaneous lumbosacral tSCS while simultaneously performing EAW. Sham Comparator: Exoskeleton-assisted walking (EAW) + sham Transcutaneous Spinal Cord Stimulation (tSCS) Arm Description: 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).
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Chris Cirnigliaro, MS, Principal investigator, James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07418398
- Sponsor's protocol ID
- RRD8-002-25M
- Other IDs
- 1IK2RD000484-01A1
- Status last verified
- Jul 2026
- First submitted
- 10 Feb 2026
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Totosy de Zepetnek JO, Craven BC, Giangregorio LM. An evaluation of the muscle-bone unit theory among individuals with chronic spinal cord injury. Spinal Cord. 2012 Feb;50(2):147-52. doi: 10.1038/sc.2011.99. Epub 2011 Sep 6.
PubMed 21894164Samejima S, Caskey CD, Inanici F, Shrivastav SR, Brighton LN, Pradarelli J, Martinez V, Steele KM, Saigal R, Moritz CT. Multisite Transcutaneous Spinal Stimulation for Walking and Autonomic Recovery in Motor-Incomplete Tetraplegia: A Single-Subject Design. Phys Ther. 2022 Jan 1;102(1):pzab228. doi: 10.1093/ptj/pzab228.
PubMed 35076067Gerasimenko Y, Gorodnichev R, Moshonkina T, Sayenko D, Gad P, Reggie Edgerton V. Transcutaneous electrical spinal-cord stimulation in humans. Ann Phys Rehabil Med. 2015 Sep;58(4):225-231. doi: 10.1016/j.rehab.2015.05.003. Epub 2015 Jul 20.
PubMed 26205686Gerasimenko YP, Lu DC, Modaber M, Zdunowski S, Gad P, Sayenko DG, Morikawa E, Haakana P, Ferguson AR, Roy RR, Edgerton VR. Noninvasive Reactivation of Motor Descending Control after Paralysis. J Neurotrauma. 2015 Dec 15;32(24):1968-80. doi: 10.1089/neu.2015.4008. Epub 2015 Aug 20.
PubMed 26077679Karelis AD, Carvalho LP, Castillo MJ, Gagnon DH, Aubertin-Leheudre M. Effect on body composition and bone mineral density of walking with a robotic exoskeleton in adults with chronic spinal cord injury. J Rehabil Med. 2017 Jan 19;49(1):84-87. doi: 10.2340/16501977-2173.
PubMed 27973679
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exoskeletal-assisted Walking Combined With Transcutaneous Spinal Cord Stimulation: Effect on Imaging and Serum Biomarkers of Skeletal Muscle Mass and Bone Strength
- ClinicalTrials.gov ID
- NCT07418398
- Acronym / sponsor ID
- RRD8-002-25M
- Conditions
- Spinal Cord Injury
- Keywords
- Spinal Cord Injury, Transcutaneous Spinal Cord Stimulation, Bone Mineral Density, Exoskeleton-Assisted Walking, Muscle Cross Sectional Area
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2030 (estimated)
- Study completion
- 1 Nov 2032 (estimated)
- First posted
- 18 Feb 2026 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental: Exoskeleton-Assisted Walking (EAW) + active Transcutaneous Spinal Cord Stimulation (tSCS) Arm Description: The EAW + active tSCS group will receive simultaneous lumbosacral tSCS while simultaneously performing EAW. Sham Comparator: Exoskeleton-assisted walking (EAW) + sham Transcutaneous Spinal Cord Stimulation (tSCS) Arm Description: 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).
| Arm | Type | Receives |
|---|---|---|
| Exoskeleton-Assisted Walking (EAW) + active Transcutaneous Spinal Cord Stimulation (tSCS) | Experimental | Device: Exoskeleton-Assisted Walking (EAW), Device: Active Transcutaneous Spinal Cord Stimulation (tSCS)The EAW + active tSCS group will receive simultaneous lumbosacral tSCS while simultaneously performing EAW. |
| Exoskeleton-assisted walking (EAW) + sham Transcutaneous Spinal Cord Stimulation (tSCS) | Sham comparator | Device: Exoskeleton-Assisted Walking (EAW), Device: Sham 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). |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Non-walkers with an SCI greater than 3 years post injury
- As measured by a member of the study staff, participants who have a lower extremity motor score greater or equal to 16 on the INSCSCI exam with an impairment grade of C or D
- Neurologic level of injury as determined by study staff between C5-T10 (completed at participant's screening)
- Capable of gripping Lofstrand crutches and/or a walker without assistance
- Wheelchair reliant 100% of the time
Key exclusion criteria (18 listed)
- As determined by the study physician from the screening health exam, a history of fragility or traumatic fractures, unhealed fractures, and signs of swelling, bruising, and discoloration of the legs
- Current bone disease diagnosis (e.g., osteomyelitis, hyperparathyroidism)
- As determined by the study physician from the screening DXA study, a T-score at the total hip < -3.5 or aBMD of the knee (proximal tibia and/or distal femur) < 0.60 g/cm2 from the DXA screen
- Positive pregnancy test at any of the study intervention or assessment visits, or if female participants plan to become pregnant over the course of the study, they will be excluded or withdrawn (if already enrolled) from participation
- Currently in a gym/rehabilitation program performing ambulatory interventions such as EAW, as determined by the study staff
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 |
|---|---|---|
| Exoskeleton-Assisted Walking (EAW)Participants will perform EAW will for 60 minutes per session for a total of 108 sessions (3 X week for 36 weeks). | Device | Exoskeleton-Assisted Walking (EAW) + active Transcutaneous Spinal Cord Stimulation (tSCS), Exoskeleton-assisted walking (EAW) + sham Transcutaneous Spinal Cord Stimulation (tSCS) |
| Sham Transcutaneous Spinal Cord Stimulation (tSCS)The lumbosacral tSCS electrical signal is set too low to have any biological effect while simultaneously performing EAW. | Device | Exoskeleton-assisted walking (EAW) + sham Transcutaneous Spinal Cord Stimulation (tSCS) |
| Active Transcutaneous Spinal Cord Stimulation (tSCS)Participants in the active tSCS group will receive simultaneous lumbosacral tSCS while simultaneously performing EAW. | Device | Exoskeleton-Assisted Walking (EAW) + active Transcutaneous Spinal Cord Stimulation (tSCS) |
Primary outcome
Muscle cross sectional area of the mid-thigh
Time frame: Obtained prior to starting the study at enrollment (baseline) and again at the 9 month study time point (post intervention).
EAW + active tSCS will increase muscle cross sectional area of the mid-thigh more than EAW + sham tSCS.
3 secondary outcomes
Bone Strength at the Distal Femur and Proximal Tibia
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
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
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).
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 22 Jul 2026.
- Background: PubMed 21894164Totosy de Zepetnek JO, Craven BC, Giangregorio LM. An evaluation of the muscle-bone unit theory among individuals with chronic spinal cord injury. Spinal Cord. 2012 Feb;50(2):147-52. doi: 10.1038/sc.2011.99. Epub 2011 Sep 6.
- Background: PubMed 35076067Samejima S, Caskey CD, Inanici F, Shrivastav SR, Brighton LN, Pradarelli J, Martinez V, Steele KM, Saigal R, Moritz CT. Multisite Transcutaneous Spinal Stimulation for Walking and Autonomic Recovery in Motor-Incomplete Tetraplegia: A Single-Subject Design. Phys Ther. 2022 Jan 1;102(1):pzab228. doi: 10.1093/ptj/pzab228.
- Background: PubMed 26205686Gerasimenko Y, Gorodnichev R, Moshonkina T, Sayenko D, Gad P, Reggie Edgerton V. Transcutaneous electrical spinal-cord stimulation in humans. Ann Phys Rehabil Med. 2015 Sep;58(4):225-231. doi: 10.1016/j.rehab.2015.05.003. Epub 2015 Jul 20.
- Background: PubMed 26077679Gerasimenko YP, Lu DC, Modaber M, Zdunowski S, Gad P, Sayenko DG, Morikawa E, Haakana P, Ferguson AR, Roy RR, Edgerton VR. Noninvasive Reactivation of Motor Descending Control after Paralysis. J Neurotrauma. 2015 Dec 15;32(24):1968-80. doi: 10.1089/neu.2015.4008. Epub 2015 Aug 20.
- Background: PubMed 27973679Karelis AD, Carvalho LP, Castillo MJ, Gagnon DH, Aubertin-Leheudre M. Effect on body composition and bone mineral density of walking with a robotic exoskeleton in adults with chronic spinal cord injury. J Rehabil Med. 2017 Jan 19;49(1):84-87. doi: 10.2340/16501977-2173.
- Individual participant dataSharing planned: No
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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.
Chris Cirnigliaro, MS principal investigator
James J. Peters Veterans Affairs Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exoskeleton-Assisted Walking (EAW) and Active Transcutaneous Spinal Cord Stimulation (tSCS) in people with Spinal Cord Injury, run by VA Office of Research and Development at 2 sites 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 10 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: opening soon, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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 Chris Cirnigliaro, MS ((973) 731-3900 ext. 2755, christopher.cirnigliaro@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle cross sectional area of the mid-thigh (time frame: Obtained prior to starting the study at enrollment (baseline) and again at the 9 month study time point (post intervention).). 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 NCT07418398, which also lists 5 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 22 Jul 2026.