Spinal Cord Stimulation and Training for Spinal Cord Injuries

This study is looking into how transcutaneous spinal cord stimulation (a non-invasive way to stimulate the spinal cord) combined with activity-based training (motor tasks) might help improve movement in people with spinal cord injuries. Researchers want to understand how these treatments affect the signals between your brain and spinal cord, both in the short term and over time. The goal is to learn more about how these treatments work so that better therapies can be developed. This study is currently recruiting healthy volunteers between 16 and 65 years old who do not have any major health problems or chronic pain. Success will be measured by changes in how your nerves respond to stimulation and how quickly you react to certain cues over a 4-week period.

Study design: This interventional study plans to enroll 120 participants. It is not specified if it is a randomized or blinded study.
What's involved: Participants will undergo electrophysiology assessments (tests of nerve activity) and engage in activity-based training and transcutaneous spinal cord stimulation. These assessments will occur before and after interventions, and at 4 weeks.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for 4 weeks after the interventions.

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Spinal Cord Stimulation and Training

Recruiting

NAAges 16–65InterventionalBasic science

Washington University School of Medicine

~120 participants

Updated 2026-04-02 on ClinicalTrials.gov

What's tested:Electrophysiology assessment - corticospinal tractElectrophysiology assessment - reticulospinal tractElectrophysiology assessment - spinal motoneuronActivity-based trainingTranscutaneous spinal cord stimulation

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Motor evoked potentials amplitude and latency

Measured over 30 minutes before and 30 minutes after intervention; 4 weeks

+2 more outcomes measured

Conditions

Spinal Cord Injuries

Where it's being run

1 sites across 1 states

Missouri1

Study leadership

Ismael Seanez, PhD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Ismael Seanez, PHD

[email protected]

314-935-7665

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Age between 16 and 65 years old

Healthy people with no major comorbidities of any organ system

Age between 16-65 years old

Traumatic SCI C4-T9 level, incomplete (ASIA C or D)

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

Exclusion

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

Use of caffeine with 3 hours of study appointment

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

What this trial measures

Motor evoked potentials amplitude and latency30 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 response30 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 persistence30 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.

Trialytics