Spinal Cord Stimulation and Training

Not Applicable

Recruiting

• Conditions: Spinal Cord Injuries
• Interventions: Other: Electrophysiology assessment - corticospinal tract; Other: Electrophysiology assessment - reticulospinal tract; Other: Electrophysiology assessment - spinal motoneuron; Other: Activity-based training; Other: Transcutaneous spinal cord stimulation

• Registration Number: NCT05472584
• Lead Sponsor: Washington University School of Medicine

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.

Study Timeline

• Study First Submitted: 2022-07-08
• Study First Submitted QC: 2022-07-20
• Study First Posted: 2022-07-25
• Study Start: 2023-07-21
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-28
• Primary Completion: 2027-08
• Study Completion: 2027-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental: Non-invasive spinal cord stimulation and precision training	Activity-based training	This arm will receive transcutaneous spinal cord stimulation as participants perform precision-control and dexterity exercises.
Experimental: Non-invasive spinal cord stimulation	Electrophysiology assessment - corticospinal tract	This arm will receive 30 minutes of transcutaneous spinal cord stimulation as participants rest.
Experimental: Long-term activity-based training with non-invasive spinal cord stimulation	Electrophysiology assessment - corticospinal tract	This arm will receive 4 weeks of activity-based training with transcutaneous spinal cord stimulation
Experimental: Non-invasive spinal cord stimulation	Electrophysiology assessment - spinal motoneuron	This arm will receive 30 minutes of transcutaneous spinal cord stimulation as participants rest.
Experimental: Activity-based training	Electrophysiology assessment - spinal motoneuron	This arm will perform 30 minutes of activity-based training using leg movements.
Experimental: Activity-based training wtih non-invasive spinal cord stimulation	Electrophysiology assessment - corticospinal tract	This arm will receive transcutaneous spinal cord stimulation as participants perform 30 minutes of activity-based training using leg movements.
Experimental: Activity-based training	Electrophysiology assessment - reticulospinal tract	This arm will perform 30 minutes of activity-based training using leg movements.
Experimental: Activity-based training wtih non-invasive spinal cord stimulation	Electrophysiology assessment - spinal motoneuron	This arm will receive transcutaneous spinal cord stimulation as participants perform 30 minutes of activity-based training using leg movements.
Experimental: Long-term activity-based training with non-invasive spinal cord stimulation	Transcutaneous spinal cord stimulation	This arm will receive 4 weeks of activity-based training with transcutaneous spinal cord stimulation
Experimental: Non-invasive spinal cord stimulation	Electrophysiology assessment - reticulospinal tract	This arm will receive 30 minutes of transcutaneous spinal cord stimulation as participants rest.
Experimental: Activity-based training	Activity-based training	This arm will perform 30 minutes of activity-based training using leg movements.
Experimental: Non-invasive spinal cord stimulation	Transcutaneous spinal cord stimulation	This arm will receive 30 minutes of transcutaneous spinal cord stimulation as participants rest.
Experimental: Activity-based training	Electrophysiology assessment - corticospinal tract	This arm will perform 30 minutes of activity-based training using leg movements.
Experimental: Activity-based training wtih non-invasive spinal cord stimulation	Transcutaneous spinal cord stimulation	This arm will receive transcutaneous spinal cord stimulation as participants perform 30 minutes of activity-based training using leg movements.
Experimental: Non-invasive spinal cord stimulation and strength training	Activity-based training	This arm will receive transcutaneous spinal cord stimulation as participants perform strengthening exercises.
Experimental: Non-invasive spinal cord stimulation and strength training	Transcutaneous spinal cord stimulation	This arm will receive transcutaneous spinal cord stimulation as participants perform strengthening exercises.
Experimental: Non-invasive spinal cord stimulation and precision training	Electrophysiology assessment - corticospinal tract	This arm will receive transcutaneous spinal cord stimulation as participants perform precision-control and dexterity exercises.
Experimental: Non-invasive spinal cord stimulation and precision training	Electrophysiology assessment - reticulospinal tract	This arm will receive transcutaneous spinal cord stimulation as participants perform precision-control and dexterity exercises.
Experimental: Non-invasive spinal cord stimulation and precision training	Electrophysiology assessment - spinal motoneuron	This arm will receive transcutaneous spinal cord stimulation as participants perform precision-control and dexterity exercises.
Experimental: Long-term activity-based training with non-invasive spinal cord stimulation	Electrophysiology assessment - reticulospinal tract	This arm will receive 4 weeks of activity-based training with transcutaneous spinal cord stimulation
Experimental: Long-term activity-based training with non-invasive spinal cord stimulation	Electrophysiology assessment - spinal motoneuron	This arm will receive 4 weeks of activity-based training with transcutaneous spinal cord stimulation
Experimental: Activity-based training wtih non-invasive spinal cord stimulation	Electrophysiology assessment - reticulospinal tract	This arm will receive transcutaneous spinal cord stimulation as participants perform 30 minutes of activity-based training using leg movements.
Experimental: Activity-based training wtih non-invasive spinal cord stimulation	Activity-based training	This arm will receive transcutaneous spinal cord stimulation as participants perform 30 minutes of activity-based training using leg movements.
Experimental: Non-invasive spinal cord stimulation and strength training	Electrophysiology assessment - corticospinal tract	This arm will receive transcutaneous spinal cord stimulation as participants perform strengthening exercises.
Experimental: Non-invasive spinal cord stimulation and strength training	Electrophysiology assessment - spinal motoneuron	This arm will receive transcutaneous spinal cord stimulation as participants perform strengthening exercises.
Experimental: Non-invasive spinal cord stimulation and strength training	Electrophysiology assessment - reticulospinal tract	This arm will receive transcutaneous spinal cord stimulation as participants perform strengthening exercises.
Experimental: Non-invasive spinal cord stimulation and precision training	Transcutaneous spinal cord stimulation	This arm will receive transcutaneous spinal cord stimulation as participants perform precision-control and dexterity exercises.
Experimental: Long-term activity-based training with non-invasive spinal cord stimulation	Activity-based training	This arm will receive 4 weeks of activity-based training with transcutaneous spinal cord stimulation

Primary Outcome Measures

Name	Time	Method
Motor evoked potentials amplitude and latency	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.
Reaction time to startle response	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.
F-wave response persistence	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 Outcome Measures

Name	Time	Method
Change in movement smoothness	Baseline, 30 minutes, and 4 weeks	This outcome is a measure of changes in movement smoothness when operating the computer cursor with the body.
Changes in time to completion from baseline	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.

Trial Locations

Locations (1)

Washington University; 🇺🇸 Saint Louis, Missouri, United States