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

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Spinal Cord Injuries

In brief

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

Key facts

Study ID

NCT05982171

Run by

Craig Hospital

People needed

30

Starts

2023-11-15

Expected to finish

2026-03-31

Last updated by the study team

2026-02-05

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• < 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

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

Where it is running

• Craig Hospital — Englewood, Colorado, United States

Full record on ClinicalTrials.gov

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