NCT05982171

Transcutaneous Spinal Cord Stimulation to Promote Walking Recovery After Spinal Cord Injury

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Craig Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to investigate the effects of transcutaneous spinal cord stimulation (TSCS) combined with exoskeleton training, as compared to exoskeleton training alone to improve motor function in individuals with incomplete spinal cord injury who are 12 months or less post-injury. Participants will be randomly assigned to a treatment group (exoskeleton training with TSCS, or exoskeleton training without TSCS). Participants in both groups will undergo a baseline evaluation, then take part in 24, 1-hour training sessions at Craig Hospital. After the 24 sessions have concluded, participants will undergo a post-treatment evaluation as well as a follow-up evaluation four weeks after training is completed. Researchers will compare the two groups by evaluating the following areas: * walking ability and speed * lower extremity strength, activation, and spasticity * trunk control * bowel and bladder function

Conditions

• Spinal Cord Injuries

Interventions

Type	Name	Description
DEVICE	Exo + TSCS	Participants will receive TSCS delivered with the ONWARD Lift system at 1ms using a 10kHz carrier frequency delivered at 30Hz, with an amplitude set for each participant based on their ability to increase voluntary movement output.
DEVICE	Exo + Sham	The ONWARD Lift system will also be used to deliver sham stimulation which will also be delivered at 1ms using a 10kHz carrier frequency delivered at 30Hz, and an amplitude of 1ma which has been used in other sham stimulation protocols and is not sufficient to induce activation of lumbosacral neuronal pools.

Timeline

• Start date: 2023-11-15
• Primary completion: 2026-02-27
• Completion: 2026-03-31
• First posted: 2023-08-08
• Last updated: 2026-02-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study