Exoskeletal-assisted Walking Combined With Transcutaneous Spinal Cord Stimulation: Effect on Imaging and Serum Biomarkers of Skeletal Muscle Mass and Bone Strength.

NCT07418398 | Not Yet Recruiting FDA Device

• 2 other identifiers: RRD8-002-25M1IK2RD000484-01A1
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 2

Brief 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. 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.

Conditions

Spinal Cord Injury

Keywords

Spinal Cord Injury; Transcutaneous Spinal Cord Stimulation; Bone Mineral Density; Exoskeleton-Assisted Walking; Muscle Cross Sectional Area

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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).

Study Arms (2)

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.

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).

Device: Exoskeleton-Assisted Walking (EAW); Device: Sham Transcutaneous Spinal Cord Stimulation (tSCS)

Interventions

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).

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) DEVICE

The lumbosacral tSCS electrical signal is set too low to have any biological effect while simultaneously performing EAW.

Exoskeleton-assisted walking (EAW) + sham Transcutaneous Spinal Cord Stimulation (tSCS)

Active Transcutaneous Spinal Cord Stimulation (tSCS) DEVICE

Participants in the active tSCS group will receive simultaneous lumbosacral tSCS while simultaneously performing EAW.

Exoskeleton-Assisted Walking (EAW) + active Transcutaneous Spinal Cord Stimulation (tSCS)

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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)

You may not qualify if:

• 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
• 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)

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

James J. Peters VA Medical Center, Bronx, NY

The Bronx, New York, 10468-3904, United States

Location

Related Publications (5)

• 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.

  PMID: 21894164 BACKGROUND

• Samejima 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.

  PMID: 35076067 BACKGROUND

• Gerasimenko 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.

  PMID: 26205686 BACKGROUND

• Gerasimenko 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.

  PMID: 26077679 BACKGROUND

• Karelis 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.

  PMID: 27973679 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Chris Cirnigliaro, MS

  James J. Peters Veterans Affairs Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chris Cirnigliaro, MS

CONTACT

(973) 731-3900; christopher.cirnigliaro@va.gov

Christopher Cardozo, MD

CONTACT

(718) 584-9000; Christopher.Cardozo@va.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 18, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2032
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)