Spinal Cord InjuriesNCT05472584
Spinal Cord Stimulation and Training
A study testing Electrophysiology assessment - corticospinal tract, Electrophysiology assessment - reticulospinal tract and Electrophysiology assessment - spinal motoneuron in people with Spinal Cord Injuries, run by Washington University School of Medicine at 1 site in United States.
Trial summary
This study will help the investigators better understand the changes in short-term excitability and long-term plasticity of corticospinal, reticulospinal and spinal neural circuits and how the changes impact the improvements of spinal cord stimulation (SCS) mediated motor function. Read more about this study
- Who is it for?
- Ages 16 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Electrophysiology assessment - corticospinal tract, Electrophysiology assessment - reticulospinal tract and Electrophysiology assessment - spinal motoneuron
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jul 2023to Aug 2027
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy Volunteers
- Age between 16 and 65 years old
- Healthy people with no major comorbidities of any organ system
- Participants with spinal cord injury (SCI)
- Age between 16-65 years old
- Traumatic SCI C4-T9 level, incomplete (ASIA C or D)
Show all 11Show fewer
- at least 1 year post injury
- Stable medical condition
- difficulty independently performing leg movements in routine activities
- able to follow simple commands
- able to speak and respond to questions
Who cannot join
- Healthy Volunteers
- Subjects younger than 16 or older than 65 years old
- Subjects not providing consent or not able to consent
- Subjects with any acute or chronic pain condition
- Subjects with any acute or chronic disease of a major organ system
- Use of analgesics within 24 hours prior to study period
Show all 33Show fewer
- Use of caffeine with 3 hours of study appointment
- Participants with spinal cord injury (SCI)
- Subjects younger than 16 or older than 65 years old
- Not willing or able to provide consent
- Any acute or chronic pain condition
- Any acute or chronic disease of a major organ system
- Use of analgesics within 24 hours prior to study appointment
- Use of caffeine with 3 hours of study appointment
- Presence of tremors, spasms and other significant involuntary movements
- Etiology of SCI other than trauma
- Concomitant neurologic disease traumatic brain injury (TBI) that will significantly impact the ability to follow through on study directions, multiple sclerosis (MS), stroke or peripheral neuropathy)
- History of significant medical illness (cardiovascular disease, uncontrolled diabetes, uncontrolled hypertension, osteoporosis, cancer, chronic obstructive pulmonary disease, severe asthma requiring hospitalization for treatment, renal insufficiency requiring dialysis, autonomic dysreflexia, etc).
- Severe joint contractures disabling or restricting lower limb movements.
- Unhealed fracture, contracture, pressure sore, urinary tract infection or other uncontrolled infections, other illnesses that might interfere with lower extremity exercises or testing activities
- Depression, anxiety, or cognitive impairment
- Deficit of visuospatial orientation
- Sitting tolerance less than 1 hour
- Severe hearing or visual deficiency
- Miss more than 3 appointments without notification
- Unable to comply with any of the procedures in the protocol
- Botulinum toxin injection in lower extremity muscles in the prior six months
- Any passive implants (osteosynthesis material, metallic plates or screws) below T9.
- Any implanted stimulator in the body (pacemaker, vagus nerve stimulator, etc.)
- History of alcoholism or another drug abuse
- Pregnancy (or possible pregnancy)
- Having an Intrathecal Baclofen Therapy Pump (ITB pump)
- History of epilepsy
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, Missouri, 63130
Ismael Seanez, PHD, 314-935-7665, ismaelseanez@wustl.edu
About this study
Official title: Neural Plasticity by Spinal Cord Stimulation and Training in People With Spinal Cord Injury
This study will help the investigators better understand the changes in short-term excitability and long-term plasticity of corticospinal, reticulospinal and spinal neural circuits and how the changes impact the improvements of spinal cord stimulation (SCS) mediated motor function.
Read the detailed description
The goal of this project is to determine the changes in short-term excitability and long-term plasticity of corticospinal, reticulospinal, and spinal neural circuits that are involved in SCS-mediated motor function improvements in individuals with spinal cord injury (SCI). The study will: (1) Determine the short-term effects in neural excitability induced by SCS and activity-based training. (2) Determine the effect of motor training on short-term changes in neural excitability enabled by SCS. (3) Determine the long-term changes in motor control and neural plasticity induced by combined SCS and activity-based training in individuals with chronic SCI. Having a better understanding of the neural mechanisms that are enhanced by SCS can allow the development of therapies that directly target the excitability and plasticity states of these structures towards improved and accelerated recovery.
- Conditions
- Spinal Cord Injuries
- Being tested
- Electrophysiology assessment - corticospinal tract, Electrophysiology assessment - reticulospinal tract, Electrophysiology assessment - spinal motoneuron, Activity-based training, Transcutaneous spinal cord stimulation
- Keywords
- spinal cord injury, 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.
Electrophysiology assessment - corticospinal tractOther
Kinematics and cortical spinal motor excitability
Electrophysiology assessment - reticulospinal tractOther
Kinematics and reticular spinal motor excitability
Electrophysiology assessment - spinal motoneuronOther
Kinematics and spinal motoneuron excitability
Activity-based trainingOther
Motor task
Transcutaneous spinal cord stimulationOther
Non-invasive spinal cord stimulation
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Non-invasive spinal cord stimulation | Experimental | This arm will receive 30 minutes of transcutaneous spinal cord stimulation as participants rest. Receives: Other: Electrophysiology assessment - corticospinal tract; Other: Electrophysiology assessment - reticulospinal tract; Other: Electrophysiology assessment - spinal motoneuron; Other: Transcutaneous spinal cord stimulation |
| Experimental: Activity-based training | Experimental | This arm will perform 30 minutes of activity-based training using leg movements. Receives: Other: Electrophysiology assessment - corticospinal tract; Other: Electrophysiology assessment - reticulospinal tract; Other: Electrophysiology assessment - spinal motoneuron; Other: Activity-based training |
| Experimental: Activity-based training wtih non-invasive spinal cord stimulation | Experimental | This arm will receive transcutaneous spinal cord stimulation as participants perform 30 minutes of activity-based training using leg movements. Receives: Other: Electrophysiology assessment - corticospinal tract; Other: Electrophysiology assessment - reticulospinal tract; Other: Electrophysiology assessment - spinal motoneuron; Other: Activity-based training; Other: Transcutaneous spinal cord stimulation |
| Experimental: Non-invasive spinal cord stimulation and strength training | Experimental | This arm will receive transcutaneous spinal cord stimulation as participants perform strengthening exercises. Receives: Other: Electrophysiology assessment - corticospinal tract; Other: Electrophysiology assessment - reticulospinal tract; Other: Electrophysiology assessment - spinal motoneuron; Other: Activity-based training; Other: Transcutaneous spinal cord stimulation |
| Experimental: Non-invasive spinal cord stimulation and precision training | Experimental | This arm will receive transcutaneous spinal cord stimulation as participants perform precision-control and dexterity exercises. Receives: Other: Electrophysiology assessment - corticospinal tract; Other: Electrophysiology assessment - reticulospinal tract; Other: Electrophysiology assessment - spinal motoneuron; Other: Activity-based training; Other: Transcutaneous spinal cord stimulation |
| Experimental: Long-term activity-based training with non-invasive spinal cord stimulation | Experimental | This arm will receive 4 weeks of activity-based training with transcutaneous spinal cord stimulation Receives: Other: Electrophysiology assessment - corticospinal tract; Other: Electrophysiology assessment - reticulospinal tract; Other: Electrophysiology assessment - spinal motoneuron; Other: Activity-based training; Other: Transcutaneous spinal cord stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Motor evoked potentials amplitude and latency
This primary outcome is a measure of changes in corticospinal tract excitability and plasticity as quantified by changes in the amplitude size and onset latency of motor evoked potentials elicited via transcranial magnetic stimulation.
Measured: 30 minutes before and 30 minutes after intervention; 4 weeks
Reaction time to startle response
This primary outcome is a measure of changes in reticulospinal tract excitability after training as quantified by changes in reaction time after a startling auditory stimulus.
Measured: 30 minutes before and 30 minutes after intervention; 4 weeks
F-wave response persistence
This primary outcome is a measure of changes in spinal motoneuron excitability as quantified by changes in the persistence of F-wave responses elicited via peripheral nerve stimulation.
Measured: 30 minutes before and 30 minutes after intervention; 4 weeks
Secondary outcomes (2)
Changes in time to completion from baseline
Participants will perform cursor control as a computer game. This outcome measure is the time it takes participants to complete each task.
Measured: Baseline, 30 minutes, and 4 weeks
Change in movement smoothness
This outcome is a measure of changes in movement smoothness when operating the computer cursor with the body.
Measured: Baseline, 30 minutes, and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2022
- Study start21 Jul 2023
- Primary completionAug 2027 (estimated)
- Study completionAug 2027 (estimated)
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.
- 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
- 120 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
- Investigators
- Ismael Seanez, PhD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05472584
- Sponsor's protocol ID
- 202206159
- Status last verified
- Mar 2026
- First submitted
- 8 Jul 2022
- Last updated
- 2 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neural Plasticity by Spinal Cord Stimulation and Training in People With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05472584
- Acronym / sponsor ID
- 202206159
- Conditions
- Spinal Cord Injuries
- Keywords
- spinal cord injury, spinal cord stimulation, rehabilitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 21 Jul 2023 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 25 Jul 2022 (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.
This study will help the investigators better understand the changes in short-term excitability and long-term plasticity of corticospinal, reticulospinal and spinal neural circuits and how the changes impact the improvements of spinal cord stimulation (SCS) mediated motor function.
Detailed description
The goal of this project is to determine the changes in short-term excitability and long-term plasticity of corticospinal, reticulospinal, and spinal neural circuits that are involved in SCS-mediated motor function improvements in individuals with spinal cord injury (SCI). The study will: (1) Determine the short-term effects in neural excitability induced by SCS and activity-based training. (2) Determine the effect of motor training on short-term changes in neural excitability enabled by SCS. (3) Determine the long-term changes in motor control and neural plasticity induced by combined SCS and activity-based training in individuals with chronic SCI. Having a better understanding of the neural mechanisms that are enhanced by SCS can allow the development of therapies that directly target the excitability and plasticity states of these structures towards improved and accelerated recovery.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Experimental: Non-invasive spinal cord stimulation | Experimental | Other: Electrophysiology assessment - corticospinal tract, Other: Electrophysiology assessment - reticulospinal tract, Other: Electrophysiology assessment - spinal motoneuron, Other: Transcutaneous spinal cord stimulationThis arm will receive 30 minutes of transcutaneous spinal cord stimulation as participants rest. |
| Experimental: Activity-based training | Experimental | Other: Electrophysiology assessment - corticospinal tract, Other: Electrophysiology assessment - reticulospinal tract, Other: Electrophysiology assessment - spinal motoneuron, Other: Activity-based trainingThis arm will perform 30 minutes of activity-based training using leg movements. |
| Experimental: Activity-based training wtih non-invasive spinal cord stimulation | Experimental | Other: Electrophysiology assessment - corticospinal tract, Other: Electrophysiology assessment - reticulospinal tract, Other: Electrophysiology assessment - spinal motoneuron, Other: Activity-based training, Other: Transcutaneous spinal cord stimulationThis arm will receive transcutaneous spinal cord stimulation as participants perform 30 minutes of activity-based training using leg movements. |
| Experimental: Non-invasive spinal cord stimulation and strength training | Experimental | Other: Electrophysiology assessment - corticospinal tract, Other: Electrophysiology assessment - reticulospinal tract, Other: Electrophysiology assessment - spinal motoneuron, Other: Activity-based training, Other: Transcutaneous spinal cord stimulationThis arm will receive transcutaneous spinal cord stimulation as participants perform strengthening exercises. |
| Experimental: Non-invasive spinal cord stimulation and precision training | Experimental | Other: Electrophysiology assessment - corticospinal tract, Other: Electrophysiology assessment - reticulospinal tract, Other: Electrophysiology assessment - spinal motoneuron, Other: Activity-based training, Other: Transcutaneous spinal cord stimulationThis arm will receive transcutaneous spinal cord stimulation as participants perform precision-control and dexterity exercises. |
| Experimental: Long-term activity-based training with non-invasive spinal cord stimulation | Experimental | Other: Electrophysiology assessment - corticospinal tract, Other: Electrophysiology assessment - reticulospinal tract, Other: Electrophysiology assessment - spinal motoneuron, Other: Activity-based training, Other: Transcutaneous spinal cord stimulationThis arm will receive 4 weeks of activity-based training with transcutaneous spinal cord stimulation |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Healthy Volunteers
- Age between 16 and 65 years old
- Healthy people with no major comorbidities of any organ system
- Participants with spinal cord injury (SCI)
- Age between 16-65 years old
Key exclusion criteria (33 listed)
- Healthy Volunteers
- Subjects younger than 16 or older than 65 years old
- Subjects not providing consent or not able to consent
- Subjects with any acute or chronic pain condition
- Subjects with any acute or chronic disease of a major organ system
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 |
|---|---|---|
| Electrophysiology assessment - corticospinal tractKinematics and cortical spinal motor excitability | Other | Experimental: Activity-based training, Experimental: Activity-based training wtih non-invasive spinal cord stimulation, Experimental: Long-term activity-based training with non-invasive spinal cord stimulation, Experimental: Non-invasive spinal cord stimulation, Experimental: Non-invasive spinal cord stimulation and precision training, Experimental: Non-invasive spinal cord stimulation and strength training |
| Electrophysiology assessment - reticulospinal tractKinematics and reticular spinal motor excitability | Other | Experimental: Activity-based training, Experimental: Activity-based training wtih non-invasive spinal cord stimulation, Experimental: Long-term activity-based training with non-invasive spinal cord stimulation, Experimental: Non-invasive spinal cord stimulation, Experimental: Non-invasive spinal cord stimulation and precision training, Experimental: Non-invasive spinal cord stimulation and strength training |
| Electrophysiology assessment - spinal motoneuronKinematics and spinal motoneuron excitability | Other | Experimental: Activity-based training, Experimental: Activity-based training wtih non-invasive spinal cord stimulation, Experimental: Long-term activity-based training with non-invasive spinal cord stimulation, Experimental: Non-invasive spinal cord stimulation, Experimental: Non-invasive spinal cord stimulation and precision training, Experimental: Non-invasive spinal cord stimulation and strength training |
| Activity-based trainingMotor task | Other | Experimental: Activity-based training, Experimental: Activity-based training wtih non-invasive spinal cord stimulation, Experimental: Long-term activity-based training with non-invasive spinal cord stimulation, Experimental: Non-invasive spinal cord stimulation and precision training, Experimental: Non-invasive spinal cord stimulation and strength training |
| Transcutaneous spinal cord stimulationNon-invasive spinal cord stimulation | Other | Experimental: Activity-based training wtih non-invasive spinal cord stimulation, Experimental: Long-term activity-based training with non-invasive spinal cord stimulation, Experimental: Non-invasive spinal cord stimulation, Experimental: Non-invasive spinal cord stimulation and precision training, Experimental: Non-invasive spinal cord stimulation and strength training |
Primary outcome
Motor evoked potentials amplitude and latency
Time frame: 30 minutes before and 30 minutes after intervention; 4 weeks
This primary outcome is a measure of changes in corticospinal tract excitability and plasticity as quantified by changes in the amplitude size and onset latency of motor evoked potentials elicited via transcranial magnetic stimulation.
Reaction time to startle response
Time frame: 30 minutes before and 30 minutes after intervention; 4 weeks
This primary outcome is a measure of changes in reticulospinal tract excitability after training as quantified by changes in reaction time after a startling auditory stimulus.
F-wave response persistence
Time frame: 30 minutes before and 30 minutes after intervention; 4 weeks
This primary outcome is a measure of changes in spinal motoneuron excitability as quantified by changes in the persistence of F-wave responses elicited via peripheral nerve stimulation.
2 secondary outcomes
Changes in time to completion from baseline
Time frame: Baseline, 30 minutes, and 4 weeks
Change in movement smoothness
Time frame: Baseline, 30 minutes, and 4 weeks
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 2 Apr 2026.
Related trials for Spinal Cord Injuries
Recruiting
Implant for Walking After Incomplete SCI
Spinal Cord Injury (SCI), Gait
Recruiting
MindEx: A Novel, Multifocal, Cognitive Brain-Machine Interface System
Paralysis; Quadriplegic, Quadraplegia
Recruiting
tSCS Combined With Rehabilitation Training in Treating Paraplegic Patients After SCI
Spinal Cord Injury, Paraplegia, Spinal
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
Recruiting
Neuromodulation for Metabolic Dysfunction
Spinal Cord Injuries (SCI), Prediabetes / Type 2 Diabetes
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.
Ismael Seanez, PhD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrophysiology assessment - corticospinal tract, Electrophysiology assessment - reticulospinal tract and Electrophysiology assessment - spinal motoneuron in people with Spinal Cord Injuries, 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 11 inclusion and 33 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 2 Apr 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 Seanez, 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?
Motor evoked potentials amplitude and latency (time frame: 30 minutes before and 30 minutes after intervention; 4 weeks). The study lists 3 primary outcomes in all. 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 2 Apr 2026.