Spatiotemporal tSCS in Spinal Cord Injury
Spatiotemporal Control of Transcutaneous Spinal Cord Stimulation for Motor Function in SCI
1 other identifier
interventional
48
1 country
1
Brief Summary
Spinal cord injury leads to long-lasting impairment, and currently, there is no cure for paralysis. Although transcutaneous spinal cord stimulation has shown promising results in recovering lost movements, its poor selectivity in muscle recruitment compared to invasive approaches limits the type of rehabilitation exercises that can be practiced. This project studies how spatial, frequency, and amplitude control of stimulation can be used to selectively target different neural pathways and muscle groups.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2026
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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 19, 2026
CompletedFirst Submitted
Initial submission to the registry
February 2, 2026
CompletedFirst Posted
Study publicly available on registry
February 9, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2030
February 12, 2026
February 1, 2026
4.6 years
February 2, 2026
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Changes in Torque
The primary outcome is a measure of changes in voluntary torque production (Nm)
30 minutes
Secondary Outcomes (2)
Muscle activation
30 minutes
Pain/Nociception
30 minutes
Study Arms (3)
No stimulation
OTHERParticipants complete the study motor tasks and assessments without transcutaneous spinal cord stimulation (tSCS).
Conventional tSCS
ACTIVE COMPARATORParticipants complete the same experimental tasks and assessments while receiving conventional, non-invasive transcutaneous spinal cord stimulation (tSCS) using a single cathode and 30 Hz.
Spatiotemporal tSCS
EXPERIMENTALParticipants complete the same tasks and assessments while receiving spatiotemporal tSCS in which stimulation parameters are systematically varied across sessions, including electrode location/configuration (spatial control), frequency, and amplitude (temporal/intensity control), to optimize targeted muscle recruitment and voluntary motor output.
Interventions
Participants complete motor tasks and outcome assessments with no spinal cord stimulation applied.
Non-invasive transcutaneous spinal cord stimulation (tSCS) is delivered at 30 Hz using a single cathode electrode targeting the lumbar spinal cord to reinforce leg motor output during study tasks
Stimulation parameters, including electrode location, stimulation frequency, and stimulation amplitude, are systematically varied to reinforce leg motor output during study tasks
Eligibility Criteria
You may qualify if:
- Age between 16 and 65 years.
- Have a spinal cord injury (neurological level C3-T12) that occurred ≥1 year (chronic stage) prior to enrollment.
- American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification C or D
- Able to voluntarily contract (motor score ≥ 1) at least two leg muscles (visual or palpable contraction).
- Use of prescription medication(s) for control of spasticity has not changed in the last 2 weeks
- Able to provide consent
- Ability to follow multiple instructions and communicate pain or discomfort
You may not qualify if:
- Progressive spinal lesions, including degenerative disorders of the spinal cord
- Pregnant, planning to become pregnant, or currently breastfeeding
- History of cardiopulmonary disease or cardiac symptoms
- Implanted stimulators of any type (baclofen pump, epidural spinal stimulator, cardiac defibrillator, pace-maker, etc.)
- Presence of orthopedic conditions that would negatively affect participation in leg exercise
- History of autonomic dysreflexia that is severe, unstable, and/or uncontrolled
- Unstable or significant medical conditions that can interfere with exercise or neurophysiological evaluations, such as severe neuropathic pain, depression, mood disorders, or other cognitive disorders
- Spasms that limit the ability to participate in leg exercise activity
- Breakdown in skin area that will be in contact with electrodes
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Washington University, St. Louis
St Louis, Missouri, 63130, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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
February 2, 2026
First Posted
February 9, 2026
Study Start
January 19, 2026
Primary Completion (Estimated)
August 31, 2030
Study Completion (Estimated)
August 31, 2030
Last Updated
February 12, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ANALYTIC CODE
- Time Frame
- IPD and supporting information will be made available no later than the time of publication of the primary results and/or at the end of the study performance period, whichever occurs first. Data will remain available for at least 5 years following the end of the study, subject to repository policies and continued availability of the hosting platforms.
- Access Criteria
- Access will be provided to qualified researchers for non-commercial scientific purposes. Shared datasets will be de-identified/anonymized and will not include direct identifiers or any information that could reasonably be used to re-identify participants. Data will be accessed via public repositories when available (e.g., Open Data Commons for Spinal Cord Injury) and/or through controlled-access request mechanisms (e.g., NICHD DASH) as applicable.
De-identified and anonymized individual participant data including kinematic measures, EMG torque, stimulation parameters, nociception/pain measures, and associated session/task metadata. Processed datasets and summary statistics used for publications will be shared. Identifiable video recordings will not be shared.