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

Conditions

• Spinal Cord Injury

Eligibility Criteria

Sex

ALL

Age

21 Years - 60 Years

Healthy Volunteers

Not accepted

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).
• 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 Details

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.

Key Dates

Start date

Jul 1, 2026

Status verified

Feb 2026

Primary completion

Jul 1, 2030

Completion

Jul 1, 2032

Study Design

Enrollment

24 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Exoskeleton-Assisted Walking (EAW) + active Transcutaneous Spinal Cord Stimulation (tSCS)
  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)
  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).

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). ]

Central Contacts

• Chris Cirnigliaro, MS
  (973) 731-3900
  [email protected]
• Christopher Cardozo, MD
  (718) 584-9000
  [email protected]

Locations (2)

Find similar trials in West Orange, NJ

Related Studies

• Exoskeleton and Spinal Cord Stimulation for SCI
  Recruiting · Kessler Foundation · West Orange, New Jersey
• Chronic Transcutaneous Stimulation to Promote Motor Function and Recovery in Individuals With Paralysis or Paresis
  EARLY_PHASE1 · Recruiting · Northwell Health · Manhasset, New York
• Autonomic Effects of Stimulation in SCI
  Recruiting · VA Office of Research and Development · The Bronx, New York
• Time Restricted Eating to Mitigate Obesity in Veterans With Spinal Cord Injury
  Enrolling By Invitation · VA Office of Research and Development · Syracuse, New York