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

NCT05982171 | Active Not Recruiting FDA Device

• 1 other identifier: IRB#2023877
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in score on Walking Index for SCI (WISCI) II

  Assesses the amount of physical assistance/devices needed for walking following paralysis from SCI (scale of 0-20 with higher score indicating less need for assistance)

  Baseline to Immediately After Intervention

Secondary Outcomes (7)

• Change in walking speed as measured by the 10 Meter Walk Test

  Baseline to Immediately After Intervention

• Change in distance walked as measured by the 6 Meter Walk Test

  Baseline to Immediately After Intervention

• Change in lower extremity strength as measured by Lower Extremity Motor Score (LEMS)

  Baseline to Post-treatment

• Change in spasm frequency and severity as measured by Penn Spasm Frequency

  Baseline to Immediately After Intervention

• Change in bowel function as measured by Neurogenic Bowel Dysfunction Scale

  Baseline to Immediately After Intervention

Study Arms (2)

Exoskeleton+Transcutaneous Spinal Cord Stimulation

EXPERIMENTAL

Treatment in this group will involve walking overground using the assistance of an exoskeleton while receiving a therapeutic level of transcutaneous spinal cord stimulation (TSCS) thoracolumbar spinal cord areas. Focus will be on stepping at a high intensity throughout the session as measured by heart rate.

Device: Exo + TSCS

Exoskeleton+Sham Stimluation

SHAM COMPARATOR

Treatment in this group will involve walking overground using the assistance of an exoskeleton while receiving a non-therapeutic level of stimulation (considered to be a sham). Focus will be on stepping at a high intensity throughout the session as measured by heart rate.

Device: Exo + Sham

Interventions

Exo + TSCS DEVICE

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.

Exoskeleton+Transcutaneous Spinal Cord Stimulation

Exo + Sham DEVICE

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.

Exoskeleton+Sham Stimluation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \< 12 months post traumatic iSCI C4-T10 with signs of upper motor neuron injury
• AIS C or D classification
• years and older
• Height 5'0" to 6'4"
• Weight 220lbs or less
• Sufficient upper extremity strength to manage a stability aide
• Medical clearance for high intensity gait training
• Walking \<1.46 m/s
• Intact skin in on pelvis, lower extremities and back
• Passive range of motion at shoulders, trunk, hips, knees \& ankles within functional limits

You may not qualify if:

• Unstable or symptomatic cardiac or respiratory issues
• Recent history of fracture, contractures, pressure injury, deep vein thrombosis, or other infection that might interfere with participation in study
• Received Botox injections to the lower extremities within the last six months
• Pregnancy
• Cauda Equina injury
• Any other issue that in the opinion of the investigator would impact study participation
• Non-English Speaking

Sponsors & Collaborators

• Craig Hospital: lead

Study Sites (1)

Craig Hospital

Englewood, Colorado, 80113-2811, United States

Location

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 Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 8, 2023
• Study Start: November 15, 2023
• Primary Completion: February 27, 2026
• Study Completion: March 31, 2026
• Last Updated: February 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)