Recruiting

Spinal Cord Stimulation & Training

Sponsor:

Washington University School of Medicine

Code:

NCT05472584

Conditions

Spinal Cord Injuries

Eligibility Criteria

Sex: All

Age: 16 - 65

Healthy Volunteers: Accepted

Interventions

Electrophysiology assessment - corticospinal tract

Electrophysiology assessment - reticulospinal tract

Electrophysiology assessment - spinal motoneuron

Activity-based training

Transcutaneous spinal cord stimulation

Study Details

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.

Conditions

Spinal Cord Injuries

Study ID

NCT05472584

Start date

Jul 21, 2023

Status verified date

Mar, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 16 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Experimental: Non-invasive spinal cord stimulation

This arm will receive 30 minutes of transcutaneous spinal cord stimulation as participants rest.

experimental: Experimental: Activity-based training

This arm will perform 30 minutes of activity-based training using leg movements.

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.

experimental: Experimental: Non-invasive spinal cord stimulation and strength training

This arm will receive transcutaneous spinal cord stimulation as participants perform strengthening exercises.

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.

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

Interventions

Electrophysiology assessment - corticospinal tract

Kinematics and cortical spinal motor excitability

Electrophysiology assessment - reticulospinal tract

Kinematics and reticular spinal motor excitability

Electrophysiology assessment - spinal motoneuron

Kinematics and spinal motoneuron excitability

Activity-based training

Motor task

Transcutaneous spinal cord stimulation

Non-invasive spinal cord stimulation

Primary outcome measure

  • Motor evoked potentials amplitude and latency [ Time Frame: 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 ]
  • F-wave response persistence [ Time Frame: 30 minutes before and 30 minutes after intervention; 4 weeks ]

Central Contacts and Locations

Central contacts

Ismael Seanez, PHD

314-935-7665ismaelseanez@wustl.edu

Locations

Washington University

Recruiting

St Louis, Missouri, United States, 63130

Contacts

Ismael Seanez, PHD

314-935-7665ismaelseanez@wustl.edu

More Information

Sponsor

Washington University School of Medicine

Last update posted

Apr 2, 2026

Last verified

Mar, 2026

Keywords

  • spinal cord injury, spinal cord stimulation, rehabilitation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-07. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-04-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.