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NCT Number: NCT05472584

Spinal Cord Stimulation and Training

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.

Recruiting

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Key information

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University

St Louis, Missouri, 63130, United States

Location status: Recruiting

Location contact

Ismael Seanez, PHD

CONTACT

[email protected]

314-935-7665

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electrophysiology assessment - corticospinal tract

Other

Kinematics and cortical spinal motor excitability

Electrophysiology assessment - reticulospinal tract

Other

Kinematics and reticular spinal motor excitability

Electrophysiology assessment - spinal motoneuron

Other

Kinematics and spinal motoneuron excitability

Activity-based training

Other

Motor task

transcutaneous spinal cord stimulation

Other

Non-invasive spinal cord stimulation

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ismael Seanez, PHD

CONTACT

[email protected]

314-935-7665

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 25, 2022
Registry last updated
Apr 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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