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Spinal Cord Stimulation and Training

Neural Plasticity by Spinal Cord Stimulation and Training in People With Spinal Cord Injury

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05472584
Enrollment
120
Registered
2022-07-25
Start date
2023-07-21
Completion date
2027-08-01
Last updated
2026-04-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injuries

Keywords

spinal cord injury, spinal cord stimulation, rehabilitation

Brief 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.

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.

Interventions

Kinematics and cortical spinal motor excitability

Kinematics and reticular spinal motor excitability

OTHERElectrophysiology assessment - spinal motoneuron

Kinematics and spinal motoneuron excitability

OTHERActivity-based training

Motor task

OTHERTranscutaneous spinal cord stimulation

Non-invasive spinal cord stimulation

Sponsors

Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Motor evoked potentials amplitude and latency30 minutes before and 30 minutes after intervention; 4 weeksThis 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 weeksThis 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 weeksThis 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.

Secondary

MeasureTime frameDescription
Changes in time to completion from baselineBaseline, 30 minutes, and 4 weeksParticipants will perform cursor control as a computer game. This outcome measure is the time it takes participants to complete each task.
Change in movement smoothnessBaseline, 30 minutes, and 4 weeksThis outcome is a measure of changes in movement smoothness when operating the computer cursor with the body.

Countries

United States

Contacts

CONTACTIsmael Seanez, PHD
ismaelseanez@wustl.edu314-935-7665
PRINCIPAL_INVESTIGATORIsmael Seanez, PhD

Washington University School of Medicine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026