Spatiotemporal tSCS in Spinal Cord Injury

Spatiotemporal Control of Transcutaneous Spinal Cord Stimulation for Motor Function in SCI

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.

Study Overview

• Status: Recruiting
• Conditions: Spinal Cord Injuries (SCI)
• Intervention / Treatment: Other: No Stimulation; Device: Conventional tSCS; Device: Spatiotemporal tSCS

Detailed Description

Spinal cord injury (SCI) is a life-altering event that leads to long-lasting motor impairment. Currently, there is no cure for paralysis. Transcutaneous spinal cord stimulation (tSCS) combined with exercise training can restore posture control, voluntary walking, and arm/hand function in people with SCI. However, its low selectivity in activating specific muscles compared to invasive approaches limits the rehabilitation exercises that can be practiced and help with recovery. This project will generate evidence-based knowledge of the neural mechanisms underlying spatial, frequency, and amplitude control of tSCS in generating different types of leg movements. Participants with SCI will perform leg movements using different stimulation parameter configurations in non-invasive tSCS. We will quantify changes in muscle recruitment, torque generation, and pain enabled by the different stimulation parameters. A clear understanding of the mechanisms by which these different parameters in non-invasive tSCS can be used to selectively target different muscle groups will promote the development of personalized therapies that directly target only those muscles that need assistance while respecting individuals' residual motor function.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ismael Seanez, PHD; Phone Number: 314-935-7665; Email: ismaelseanez@wustl.edu
• Study Contact Backup: Name: Carolyn Atkinson, BS; Phone Number: 314-935-4530; Email: a.carolyn@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63130
      • Recruiting
      • Washington University, St. Louis
      • Contact: Ismael Seanez, PHD; Phone Number: 314-935-7665; Email: ismaelseanez@wustl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age between 16 and 65 years.
2. Have a spinal cord injury (neurological level C3-T12) that occurred ≥1 year (chronic stage) prior to enrollment.
3. American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification C or D
4. Able to voluntarily contract (motor score ≥ 1) at least two leg muscles (visual or palpable contraction).
5. Use of prescription medication(s) for control of spasticity has not changed in the last 2 weeks
6. Able to provide consent
7. Ability to follow multiple instructions and communicate pain or discomfort

Exclusion Criteria:

1. Progressive spinal lesions, including degenerative disorders of the spinal cord
2. Pregnant, planning to become pregnant, or currently breastfeeding
3. History of cardiopulmonary disease or cardiac symptoms
4. Implanted stimulators of any type (baclofen pump, epidural spinal stimulator, cardiac defibrillator, pace-maker, etc.)
5. Presence of orthopedic conditions that would negatively affect participation in leg exercise
6. History of autonomic dysreflexia that is severe, unstable, and/or uncontrolled
7. 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
8. Spasms that limit the ability to participate in leg exercise activity
9. Breakdown in skin area that will be in contact with electrodes

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: No stimulation; Participants complete the study motor tasks and assessments without transcutaneous spinal cord stimulation (tSCS).	Other: No Stimulation; Participants complete motor tasks and outcome assessments with no spinal cord stimulation applied.
Active Comparator: Conventional tSCS; Participants complete the same experimental tasks and assessments while receiving conventional, non-invasive transcutaneous spinal cord stimulation (tSCS) using a single cathode and 30 Hz.	Device: Conventional tSCS; 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
Experimental: Spatiotemporal tSCS; Participants 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.	Device: Spatiotemporal tSCS; Stimulation parameters, including electrode location, stimulation frequency, and stimulation amplitude, are systematically varied to reinforce leg motor output during study tasks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Torque	The primary outcome is a measure of changes in voluntary torque production (Nm)	30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle activation	Muscle activation will be measured through electromyography as the peak-to-peak of the evoked responses (mV)	30 minutes
Pain/Nociception	Pain will be evaluated using the Nociception Level (NOL) index during the different stimulation conditions. (Range: 0-100, 0 = no detectable nociceptive response, 100 = extreme nociceptive response)	30 minutes

Collaborators and Investigators

• Sponsor: Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2026
• Primary Completion (Estimated): August 31, 2030
• Study Completion (Estimated): August 31, 2030

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 2, 2026
• First Posted (Actual): February 9, 2026

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: rehabilitation; spinal cord injury; transcutaneous spinal cord stimulation
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries
• Other Study ID Numbers: 202506064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No