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Recruiting NCT07397559

Spatiotemporal tSCS in Spinal Cord Injury

No phase Interventional Spinal Cord Injuries (SCI)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: No Stimulation, Conventional tSCS, Spatiotemporal tSCS.
Who it may be relevant to
Registry conditions: Spinal Cord Injuries (SCI). Basic parameters: 16 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • Other No Stimulation
    Participants complete motor tasks and outcome assessments with no spinal cord stimulation applied.
  • 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
  • Device Spatiotemporal tSCS
    Stimulation parameters, including electrode location, stimulation frequency, and stimulation amplitude, are systematically varied to reinforce leg motor output during study tasks

Primary outcome measures

  • Changes in Torque [Time frame: 30 minutes]
Secondary outcome measures (2)
  • Muscle activation [Time frame: 30 minutes]
  • Pain/Nociception [Time frame: 30 minutes]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Open label
Primary purpose
Basic science

Study locations

United States · 1 center
  • Washington University, St. Louis — St Louis

Identifiers

NCT: NCT07397559 · 202506064

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗