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

Craig Hospital

Status: Enrolling

Conditions: Spinal Cord Injuries

Treatments: Device: Exo + TSCS; Device: Exo + Sham

Study type: Interventional

Funder types: Other

Identifiers

NCT05982171

IRB#2023877

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

Exoskeleton+Transcutaneous Spinal Cord Stimulation

Experimental group

Description:

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.

Treatment:

Device: Exo + TSCS

Exoskeleton+Sham Stimluation

Sham Comparator group

Description:

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.

Treatment:

Device: Exo + Sham