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NCT Number: NCT07397559

Spatiotemporal tSCS in Spinal Cord Injury

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.

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Key information

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University, St. Louis

St Louis, Missouri, 63130, United States

Location status: Recruiting

Location contact

Ismael Seáñez, PhD

CONTACT

[email protected]

314-935-7665

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

No stimulation

Other

Participants complete motor tasks and outcome assessments with no spinal cord stimulation applied.

Conventional tSCS

Device

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

Spatiotemporal tSCS

Device

Stimulation parameters, including electrode location, stimulation frequency, and stimulation amplitude, are systematically varied to reinforce leg motor output during study tasks

Primary outcomes

  1. Changes in Torque

    Time frame: 30 minutes

    The primary outcome is a measure of changes in voluntary torque production (Nm)

Secondary outcomes

  1. Muscle activation

    Time frame: 30 minutes

    Muscle activation will be measured through electromyography as the peak-to-peak of the evoked responses (mV)

  2. Pain/Nociception

    Time frame: 30 minutes

    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)

Study contacts

Contact information is provided by the study sponsor or research team.

Carolyn Atkinson, BS

CONTACT

[email protected]

314-935-4530

Ismael Seáñez, PhD

CONTACT

[email protected]

314-935-7665

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Feb 9, 2026
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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