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NCT Number: NCT05982171

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

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Craig Hospital

Englewood, Colorado, 80113-2811, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • < 12 months post traumatic iSCI C4-T10 with signs of upper motor neuron injury
  • AIS C or D classification
  • 18 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Baseline to Immediately After Intervention

    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)

Secondary outcomes

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

    Time frame: Baseline to Immediately After Intervention

    Participants walk a ten-meter track; time to walk the middle six meters is recorded and converted to meters/second (speed)

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

    Time frame: Baseline to Immediately After Intervention

    Measures distance walked (in meters) over 6 minute time period

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

    Time frame: Baseline to Post-treatment

    Assesses strength in 10 lower extremity muscle groups (each muscle scored 0-5 with higher score for greater strength; total score ranges 0-50.

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

    Time frame: Baseline to Immediately After Intervention

    Self-report measure of perception of spasticity frequency (0 to 5 scale with higher score more frequent spasms) and severity (1-3 scale with higher score more severe spasms)

  5. Change in bowel function as measured by Neurogenic Bowel Dysfunction Scale

    Time frame: Baseline to Immediately After Intervention

    Symptom based questionnaire evaluating bowel dysfuntion and its impact on quality of life (score 0-47 with higher score indicating greater bowel dysfunction)

  6. Change in bladder function as measured by Neurogenic Bladder Symptom Scale

    Time frame: Baseline to Immediately After Intervention

    Symptom based questionnaire evaluating bladder function and its impact on quality of lifehe Neurogenic Bladder Symptom Score (NBSS) is a validated 24 item questionnaire that measures bladder symptoms across 3 different domains: incontinence (scored 0-29), storage and voiding (scored 0-22), and consequences (scored 0-23); there is a single general urinary QOL question scored from 0 (pleased) to 4 (unhappy

  7. Change in balance/trunk control as measure by the Function in Sitting Test Spinal Cord Injury

    Time frame: Baseline to Immediately After Intervention

    Assesses static, proactive, and reactive balance as well as sensory integration. Each area assessed on scale of 0-4 with higher score indicating more independent trunk control.

Sponsors and collaborators

Lead sponsor

Craig Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Aug 8, 2023
Registry last updated
Feb 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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