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

NCT ID: NCT05982171

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-15
• Study Completion Date: 2025-12-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Exoskeleton+Transcutaneous Spinal Cord Stimulation

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.

Group Type: EXPERIMENTAL

Exo + TSCS

Intervention Type: 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+Sham Stimluation

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.

Group Type: SHAM_COMPARATOR

Exo + Sham

Intervention Type: 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.

Interventions

Exo + TSCS

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.

Intervention Type: DEVICE

Exo + Sham

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Craig Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Craig Hospital

Englewood, Colorado, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Clare Morey, MA

Role: CONTACT

cmorey@craighospital.org

303-789-8621

Katie Hays, DPT

Role: CONTACT

khays@craighospital.org

303-789-8276

Facility Contacts

Clare Morey, MA

Role: primary

cmorey@craighospital.org

303-789-8621

Other Identifiers

IRB#2023877

Identifier Type: -

Identifier Source: org_study_id