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

Last updated: December 19, 2024
Sponsor: Craig Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Spinal Cord Injuries

Treatment

Exo + TSCS

Exo + Sham

Clinical Study ID

NCT05982171
IRB#2023877
  • Ages > 18
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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 functionallimits

Exclusion

Exclusion Criteria:

  • Unstable or symptomatic cardiac or respiratory issues

  • Recent history of fracture, contractures, pressure injury, deep vein thrombosis, orother 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 studyparticipation

  • Non-English Speaking

Study Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Exo + TSCS
Phase:
Study Start date:
November 15, 2023
Estimated Completion Date:
May 15, 2025

Connect with a study center

  • Craig Hospital

    Englewood, Colorado 80113-2811
    United States

    Active - Recruiting

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