Health TrialsbyHealthPanel

Spatiotemporal tSCS in Spinal Cord Injury

ConditionSpinal Cord Injuries (SCI)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-65
SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.)

Trial design

Design model

Crossover

Treatments tested in this trial

  • No Stimulation

    Other intervention

    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

Treatment groups

48 Participants
are divided into 3 treatment groups
Group A: No stimulationOther 1 intervention
Group B: Conventional tSCSActive comparator 1 intervention
Group C: Spatiotemporal tSCSExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Changes in Torque

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

Time frame
30 minutes

Secondary outcomes

1

Muscle activation

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

Time frame
30 minutes
2

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)

Time frame
30 minutes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Washington University School of Medicine

Lead sponsor

Source ClinicalTrials.gov
Apply now