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

Spinal Cord Injuries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05982171
• Other study ID #: IRB#2023877
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2023
• Est. completion date: September 15, 2024

Study information

• Verified date: February 2024
• Source: Craig Hospital
• Contact: Clare Morey, MA
• Phone: 303-789-8621
• Email: cmorey[@]craighospital.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 15, 2024
• Est. primary completion date: September 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Craig Hospital	Englewood	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Craig Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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