Spinal Cord Stimulation and Training

March 31, 2026 updated by: Ismael Seáñez, Washington University School of Medicine

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Missouri
      • St Louis, Missouri, United States, 63130
        • Recruiting
        • Washington University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

16 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Healthy Volunteers

  • Age between 16 and 65 years old
  • Healthy people with no major comorbidities of any organ system

Exclusion Criteria:

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
  • Use of caffeine with 3 hours of study appointment

Inclusion criteria:

Participants with spinal cord injury (SCI)

  • 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 criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: Non-invasive spinal cord stimulation
This arm will receive 30 minutes of transcutaneous spinal cord stimulation as participants rest.
Other: Electrophysiology assessment - corticospinal tract
Kinematics and cortical spinal motor excitability
Other: Electrophysiology assessment - reticulospinal tract
Kinematics and reticular spinal motor excitability
Other: Electrophysiology assessment - spinal motoneuron
Kinematics and spinal motoneuron excitability
Other: Transcutaneous spinal cord stimulation
Non-invasive spinal cord stimulation
Experimental: Experimental: Activity-based training
This arm will perform 30 minutes of activity-based training using leg movements.
Other: Electrophysiology assessment - corticospinal tract
Kinematics and cortical spinal motor excitability
Other: Electrophysiology assessment - reticulospinal tract
Kinematics and reticular spinal motor excitability
Other: Electrophysiology assessment - spinal motoneuron
Kinematics and spinal motoneuron excitability
Other: Activity-based training
Motor task
Experimental: Experimental: Activity-based training wtih non-invasive spinal cord stimulation
This arm will receive transcutaneous spinal cord stimulation as participants perform 30 minutes of activity-based training using leg movements.
Other: Electrophysiology assessment - corticospinal tract
Kinematics and cortical spinal motor excitability
Other: Electrophysiology assessment - reticulospinal tract
Kinematics and reticular spinal motor excitability
Other: Electrophysiology assessment - spinal motoneuron
Kinematics and spinal motoneuron excitability
Other: Transcutaneous spinal cord stimulation
Non-invasive spinal cord stimulation
Other: Activity-based training
Motor task
Experimental: Experimental: Non-invasive spinal cord stimulation and strength training
This arm will receive transcutaneous spinal cord stimulation as participants perform strengthening exercises.
Other: Electrophysiology assessment - corticospinal tract
Kinematics and cortical spinal motor excitability
Other: Electrophysiology assessment - reticulospinal tract
Kinematics and reticular spinal motor excitability
Other: Electrophysiology assessment - spinal motoneuron
Kinematics and spinal motoneuron excitability
Other: Transcutaneous spinal cord stimulation
Non-invasive spinal cord stimulation
Other: Activity-based training
Motor task
Experimental: Experimental: Non-invasive spinal cord stimulation and precision training
This arm will receive transcutaneous spinal cord stimulation as participants perform precision-control and dexterity exercises.
Other: Electrophysiology assessment - corticospinal tract
Kinematics and cortical spinal motor excitability
Other: Electrophysiology assessment - reticulospinal tract
Kinematics and reticular spinal motor excitability
Other: Electrophysiology assessment - spinal motoneuron
Kinematics and spinal motoneuron excitability
Other: Transcutaneous spinal cord stimulation
Non-invasive spinal cord stimulation
Other: Activity-based training
Motor task
Experimental: Experimental: Long-term activity-based training with non-invasive spinal cord stimulation
This arm will receive 4 weeks of activity-based training with transcutaneous spinal cord stimulation
Other: Electrophysiology assessment - corticospinal tract
Kinematics and cortical spinal motor excitability
Other: Electrophysiology assessment - reticulospinal tract
Kinematics and reticular spinal motor excitability
Other: Electrophysiology assessment - spinal motoneuron
Kinematics and spinal motoneuron excitability
Other: Transcutaneous spinal cord stimulation
Non-invasive spinal cord stimulation
Other: Activity-based training
Motor task

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
30 minutes before and 30 minutes after intervention; 4 weeks
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.
30 minutes before and 30 minutes after intervention; 4 weeks
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.
30 minutes before and 30 minutes after intervention; 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in time to completion from baseline
Time Frame: Baseline, 30 minutes, and 4 weeks
Participants will perform cursor control as a computer game. This outcome measure is the time it takes participants to complete each task.
Baseline, 30 minutes, and 4 weeks
Change in movement smoothness
Time Frame: Baseline, 30 minutes, and 4 weeks
This outcome is a measure of changes in movement smoothness when operating the computer cursor with the body.
Baseline, 30 minutes, and 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Washington University School of Medicine

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ismael Seanez, PhD, Washington University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 21, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 8, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202206159

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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