Spinal Cord Injuries (SCI)NCT07397559
Spatiotemporal tSCS in Spinal Cord Injury
A study testing No Stimulation, Conventional tSCS and Spatiotemporal tSCS in people with Spinal Cord Injuries (SCI), run by Washington University School of Medicine at 1 site in United States.
Trial summary
Spinal cord injury leads to long-lasting impairment, and currently, there is no cure for paralysis. Although transcutaneous spinal cord stimulation has shown promising results in recovering lost movements, its poor selectivity in muscle recruitment compared to invasive approaches limits the type of rehabilitation… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Spinal Cord Injuries (SCI)
- What is being tested?
- No Stimulation, Conventional tSCS and Spatiotemporal tSCS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2026to 31 Aug 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age between 16 and 65 years.
- Have a spinal cord injury (neurological level C3-T12) that occurred ≥1 year (chronic stage) prior to enrollment.
- American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification C or D
- Able to voluntarily contract (motor score ≥ 1) at least two leg muscles (visual or palpable contraction).
- Use of prescription medication(s) for control of spasticity has not changed in the last 2 weeks
- Able to provide consent
- Ability to follow multiple instructions and communicate pain or discomfort
Who cannot join
- Progressive spinal lesions, including degenerative disorders of the spinal cord
- Pregnant, planning to become pregnant, or currently breastfeeding
- History of cardiopulmonary disease or cardiac symptoms
- Implanted stimulators of any type (baclofen pump, epidural spinal stimulator, cardiac defibrillator, pace-maker, etc.)
- Presence of orthopedic conditions that would negatively affect participation in leg exercise
- History of autonomic dysreflexia that is severe, unstable, and/or uncontrolled
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- Unstable or significant medical conditions that can interfere with exercise or neurophysiological evaluations, such as severe neuropathic pain, depression, mood disorders, or other cognitive disorders
- Spasms that limit the ability to participate in leg exercise activity
- Breakdown in skin area that will be in contact with electrodes
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University, St. Louis
St Louis, Missouri, 63130
Ismael Seáñez, PhD, 314-935-7665, ismaelseanez@wustl.edu
About this study
Official title: Spatiotemporal Control of Transcutaneous Spinal Cord Stimulation for Motor Function in SCI
Spinal cord injury leads to long-lasting impairment, and currently, there is no cure for paralysis. Although transcutaneous spinal cord stimulation has shown promising results in recovering lost movements, its poor selectivity in muscle recruitment compared to invasive approaches limits the type of rehabilitation exercises that can be practiced. This project studies how spatial, frequency, and amplitude control of stimulation can be used to selectively target different neural pathways and muscle groups.
Read the detailed description
Spinal cord injury (SCI) is a life-altering event that leads to long-lasting motor impairment. Currently, there is no cure for paralysis. Transcutaneous spinal cord stimulation (tSCS) combined with exercise training can restore posture control, voluntary walking, and arm/hand function in people with SCI. However, its low selectivity in activating specific muscles compared to invasive approaches limits the rehabilitation exercises that can be practiced and help with recovery. This project will generate evidence-based knowledge of the neural mechanisms underlying spatial, frequency, and amplitude control of tSCS in generating different types of leg movements. Participants with SCI will perform leg movements using different stimulation parameter configurations in non-invasive tSCS. We will quantify changes in muscle recruitment, torque generation, and pain enabled by the different stimulation parameters. A clear understanding of the mechanisms by which these different parameters in non-invasive tSCS can be used to selectively target different muscle groups will promote the development of personalized therapies that directly target only those muscles that need assistance while respecting individuals' residual motor function.
- Conditions
- Spinal Cord Injuries (SCI)
- Being tested
- No Stimulation, Conventional tSCS, Spatiotemporal tSCS
- Keywords
- spinal cord injury, transcutaneous spinal cord stimulation, rehabilitation
- 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.
No StimulationOther
Participants complete motor tasks and outcome assessments with no spinal cord stimulation applied.
Conventional tSCSDevice
Non-invasive transcutaneous spinal cord stimulation (tSCS) is delivered at 30 Hz using a single cathode electrode targeting the lumbar spinal cord to reinforce leg motor output during study tasks
Spatiotemporal tSCSDevice
Stimulation parameters, including electrode location, stimulation frequency, and stimulation amplitude, are systematically varied to reinforce leg motor output during study tasks
| Study group | Role | What they receive |
|---|---|---|
| No stimulation | Other | Participants complete the study motor tasks and assessments without transcutaneous spinal cord stimulation (tSCS). Receives: Other: No Stimulation |
| Conventional tSCS | Active comparator | Participants complete the same experimental tasks and assessments while receiving conventional, non-invasive transcutaneous spinal cord stimulation (tSCS) using a single cathode and 30 Hz. Receives: Device: Conventional tSCS |
| Spatiotemporal tSCS | Experimental | Participants complete the same tasks and assessments while receiving spatiotemporal tSCS in which stimulation parameters are systematically varied across sessions, including electrode location/configuration (spatial control), frequency, and amplitude (temporal/intensity control), to optimize targeted muscle recruitment and voluntary motor output. Receives: Device: Spatiotemporal tSCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Torque
The primary outcome is a measure of changes in voluntary torque production (Nm)
Measured: 30 minutes
Secondary outcomes (2)
Muscle activation
Muscle activation will be measured through electromyography as the peak-to-peak of the evoked responses (mV)
Measured: 30 minutes
Pain/Nociception
Pain will be evaluated using the Nociception Level (NOL) index during the different stimulation conditions. (Range: 0-100, 0 = no detectable nociceptive response, 100 = extreme nociceptive response)
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start19 Jan 2026
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ismael Seáñez, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397559
- Sponsor's protocol ID
- 202506064
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified and anonymized individual participant data including kinematic measures, EMG torque, stimulation parameters, nociception/pain measures, and associated session/task metadata. Processed datasets and summary statistics used for publications will be shared. Identifiable video recordings will not be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spatiotemporal Control of Transcutaneous Spinal Cord Stimulation for Motor Function in SCI
- ClinicalTrials.gov ID
- NCT07397559
- Acronym / sponsor ID
- 202506064
- Conditions
- Spinal Cord Injuries (SCI)
- Keywords
- spinal cord injury, transcutaneous spinal cord stimulation, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 19 Jan 2026 (actual)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Spinal cord injury leads to long-lasting impairment, and currently, there is no cure for paralysis. Although transcutaneous spinal cord stimulation has shown promising results in recovering lost movements, its poor selectivity in muscle recruitment compared to invasive approaches limits the type of rehabilitation exercises that can be practiced. This project studies how spatial, frequency, and amplitude control of stimulation can be used to selectively target different neural pathways and muscle groups.
Detailed description
Spinal cord injury (SCI) is a life-altering event that leads to long-lasting motor impairment. Currently, there is no cure for paralysis. Transcutaneous spinal cord stimulation (tSCS) combined with exercise training can restore posture control, voluntary walking, and arm/hand function in people with SCI. However, its low selectivity in activating specific muscles compared to invasive approaches limits the rehabilitation exercises that can be practiced and help with recovery. This project will generate evidence-based knowledge of the neural mechanisms underlying spatial, frequency, and amplitude control of tSCS in generating different types of leg movements. Participants with SCI will perform leg movements using different stimulation parameter configurations in non-invasive tSCS. We will quantify changes in muscle recruitment, torque generation, and pain enabled by the different stimulation parameters. A clear understanding of the mechanisms by which these different parameters in non-invasive tSCS can be used to selectively target different muscle groups will promote the development of personalized therapies that directly target only those muscles that need assistance while respecting individuals' residual motor function.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No stimulation | Other | Other: No StimulationParticipants complete the study motor tasks and assessments without transcutaneous spinal cord stimulation (tSCS). |
| Conventional tSCS | Active comparator | Device: Conventional tSCSParticipants complete the same experimental tasks and assessments while receiving conventional, non-invasive transcutaneous spinal cord stimulation (tSCS) using a single cathode and 30 Hz. |
| Spatiotemporal tSCS | Experimental | Device: Spatiotemporal tSCSParticipants complete the same tasks and assessments while receiving spatiotemporal tSCS in which stimulation parameters are systematically varied across sessions, including electrode location/configuration (spatial control), frequency, and amplitude (temporal/intensity control), to optimize targeted muscle recruitment and voluntary motor output. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 16 and 65 years.
- Have a spinal cord injury (neurological level C3-T12) that occurred ≥1 year (chronic stage) prior to enrollment.
- American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification C or D
- Able to voluntarily contract (motor score ≥ 1) at least two leg muscles (visual or palpable contraction).
- Use of prescription medication(s) for control of spasticity has not changed in the last 2 weeks
Key exclusion criteria (9 listed)
- Progressive spinal lesions, including degenerative disorders of the spinal cord
- Pregnant, planning to become pregnant, or currently breastfeeding
- History of cardiopulmonary disease or cardiac symptoms
- Implanted stimulators of any type (baclofen pump, epidural spinal stimulator, cardiac defibrillator, pace-maker, etc.)
- Presence of orthopedic conditions that would negatively affect participation in leg exercise
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No StimulationParticipants complete motor tasks and outcome assessments with no spinal cord stimulation applied. | Other | No stimulation |
| Conventional tSCSNon-invasive transcutaneous spinal cord stimulation (tSCS) is delivered at 30 Hz using a single cathode electrode targeting the lumbar spinal cord to reinforce leg motor output during study tasks | Device | Conventional tSCS |
| Spatiotemporal tSCSStimulation parameters, including electrode location, stimulation frequency, and stimulation amplitude, are systematically varied to reinforce leg motor output during study tasks | Device | Spatiotemporal tSCS |
Primary outcome
Changes in Torque
Time frame: 30 minutes
The primary outcome is a measure of changes in voluntary torque production (Nm)
2 secondary outcomes
Muscle activation
Time frame: 30 minutes
Pain/Nociception
Time frame: 30 minutes
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Yes. De-identified and anonymized individual participant data including kinematic measures, EMG torque, stimulation parameters, nociception/pain measures, and associated session/task metadata. Processed datasets and summary statistics used for publications will be shared. Identifiable video recordings will not be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing No Stimulation, Conventional tSCS and Spatiotemporal tSCS in people with Spinal Cord Injuries (SCI), run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ismael Seáñez, PhD (314-935-7665, ismaelseanez@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Torque (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.