Spinal Cord Stimulation and Training
Neural Plasticity by Spinal Cord Stimulation and Training in People With Spinal Cord Injury
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2023
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 8, 2022
CompletedFirst Posted
Study publicly available on registry
July 25, 2022
CompletedStudy Start
First participant enrolled
July 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2027
April 2, 2026
March 1, 2026
4 years
July 8, 2022
March 31, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Motor evoked potentials amplitude and latency
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
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
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 Outcomes (2)
Changes in time to completion from baseline
Baseline, 30 minutes, and 4 weeks
Change in movement smoothness
Baseline, 30 minutes, and 4 weeks
Study Arms (6)
Experimental: Non-invasive spinal cord stimulation
EXPERIMENTALThis arm will receive 30 minutes of transcutaneous spinal cord stimulation as participants rest.
Experimental: Activity-based training
EXPERIMENTALThis arm will perform 30 minutes of activity-based training using leg movements.
Experimental: Activity-based training wtih non-invasive spinal cord stimulation
EXPERIMENTALThis 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
EXPERIMENTALThis arm will receive transcutaneous spinal cord stimulation as participants perform strengthening exercises.
Experimental: Non-invasive spinal cord stimulation and precision training
EXPERIMENTALThis 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
EXPERIMENTALThis arm will receive 4 weeks of activity-based training with transcutaneous spinal cord stimulation
Interventions
Kinematics and cortical spinal motor excitability
Kinematics and reticular spinal motor excitability
Kinematics and spinal motoneuron excitability
Motor task
Non-invasive spinal cord stimulation
Eligibility Criteria
You may qualify if:
- Healthy Volunteers
- Age between 16 and 65 years old
- Healthy people with no major comorbidities of any organ system
You may not qualify if:
- 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
- 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
- +26 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University
St Louis, Missouri, 63130, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ismael Seanez, PhD
Washington University School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Biomedical Engineering and Neurosurgery
Study Record Dates
First Submitted
July 8, 2022
First Posted
July 25, 2022
Study Start
July 21, 2023
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2027
Last Updated
April 2, 2026
Record last verified: 2026-03