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

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries
• Intervention / Treatment: Device: Exo + TSCS; Device: Exo + Sham

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Clare Morey, MA; Phone Number: 303-789-8621; Email: cmorey@craighospital.org
• Study Contact Backup: Name: Katie Hays, DPT; Phone Number: 303-789-8276; Email: khays@craighospital.org

Study Locations

• United States
  • Colorado
    • Englewood, Colorado, United States, 80113-2811
      • Recruiting
      • Craig Hospital
      • Contact: Clare Morey, MA; Phone Number: 303-789-8621; Email: cmorey@craighospital.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Sham Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in score on Walking Index for SCI (WISCI) II	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)	Baseline to Immediately After Intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in walking speed as measured by the 10 Meter Walk Test	Participants walk a ten-meter track; time to walk the middle six meters is recorded and converted to meters/second (speed)	Baseline to Immediately After Intervention
Change in distance walked as measured by the 6 Meter Walk Test	Measures distance walked (in meters) over 6 minute time period	Baseline to Immediately After Intervention
Change in lower extremity strength as measured by Lower Extremity Motor Score (LEMS)	Assesses strength in 10 lower extremity muscle groups (each muscle scored 0-5 with higher score for greater strength; total score ranges 0-50.	Baseline to Post-treatment
Change in spasm frequency and severity as measured by Penn Spasm Frequency	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)	Baseline to Immediately After Intervention
Change in bowel function as measured by Neurogenic Bowel Dysfunction Scale	Symptom based questionnaire evaluating bowel dysfuntion and its impact on quality of life (score 0-47 with higher score indicating greater bowel dysfunction)	Baseline to Immediately After Intervention
Change in bladder function as measured by Neurogenic Bladder Symptom Scale	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	Baseline to Immediately After Intervention
Change in balance/trunk control as measure by the Function in Sitting Test Spinal Cord Injury	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.	Baseline to Immediately After Intervention

Collaborators and Investigators

• Sponsor: Craig Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2023
• Primary Completion (Estimated): September 15, 2024
• Study Completion (Estimated): September 15, 2024

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: August 1, 2023
• First Posted (Actual): August 8, 2023

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Spinal Cord Diseases; Wounds and Injuries; Spinal Cord Injuries
• Other Study ID Numbers: IRB#2023877

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No