Spinal Cord InjuriesNCT05982171
Transcutaneous Spinal Cord Stimulation to Promote Walking Recovery After Spinal Cord Injury
A study testing Exo + TSCS in people with Spinal Cord Injuries, run by Craig Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Exo + TSCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2023to 31 Mar 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- < 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
Show all 10Show fewer
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Exo + TSCS, Exo + Sham
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exo + TSCSDevice
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 + ShamDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Exoskeleton+Transcutaneous Spinal Cord Stimulation | Experimental | 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. Receives: Device: Exo + TSCS |
| Exoskeleton+Sham Stimluation | Sham comparator | 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. Receives: Device: Exo + Sham |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to Immediately After Intervention
Secondary outcomes (7)
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)
Measured: 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
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: Baseline to Immediately After Intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2023
- Study start15 Nov 2023
- Primary completion27 Feb 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05982171
- Sponsor's protocol ID
- IRB#2023877
- Status last verified
- Oct 2026
- First submitted
- 24 Jul 2023
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No