Effect of tSCS on Ankle Movement Training in Individuals With SCI

Condition(s) studied

Investigational drug(s) / intervention(s)

Transcutaneous spinal cord stimulation (tSCS): The subjects will undergo 20 minutes transcutaneous spinal cord stimulation (tSCS).

Short-term Machine-Assisted Ankle Movement Training with tSCS: The subjects will undergo 30 minutes of machine-assisted ankle movement training combined with transcutaneous spinal cord stimulation (tSCS) at a time

Long-term Effects of Machine-Assisted Ankle Movement Training with tSCS: The subjects will undergo machine-assisted ankle movement training combined with transcutaneous spinal cord stimulation (tSCS). Each session will last for 30 minutes, conducted three times per week, over a period of four weeks.

Study summary

This clinical trial explores the effectiveness of transcutaneous spinal cord stimulation (tSCS), a non-invasive technique, in facilitating spinal circuitry adaptation in individuals with spinal cord injury (SCI). While epidural spinal cord stimulation (eSCS) has shown functional benefits, its application is limited by the side effects associated with implanted electrodes. tSCS, which shares a similar mechanism but does not require surgery, has yet to be extensively studied in large human trials.

The study aims to:

Determine optimal tSCS parameters for non-invasive spinal stimulation. Investigate the priming effect of tSCS on spinal circuitry during machine-assisted ankle movement training.

Examine the long-term clinical outcomes of combining tSCS with ankle movement training in individuals with incomplete SCI.

The trial will include both healthy participants and individuals with complete and incomplete SCI, using the soleus post-activation depression (PAD) model to evaluate spinal circuitry adaptation. The results will provide insights into spinal re-adaptation and potentially introduce a novel, non-invasive approach for SCI rehabilitation.

Eligibility

Primary outcome measure(s)

• Latency and amplitude of the H-reflex — Baseline, 4 weeks
  The H-reflex will be elicited through electrical stimulation of the tibial nerve (or sciatic nerve) using electromyography (EMG) to record the resulting muscle response.
• Latency, amplitude, and duration of the M-wave — Baseline, 4 weeks
  The M-wave will be elicited by direct electrical stimulation of the motor nerve (e.g., tibial nerve) and recorded using electromyography (EMG) from the target muscle (e.g., soleus muscle).
• Level of Post-Activation Depression (PAD) of the H-reflex — Baseline, 4 weeks
  The H-reflex will be elicited by electrical stimulation of the tibial nerve (or other motor nerves), and PAD will be assessed by measuring the reduction in H-reflex amplitude following a series of repetitive stimuli. The amplitude of the H-reflex after repeated stimulation will be compared to the baseline single stimulus.
• Latency and amplitude of the Posterior Root Muscle (PRM) reflex — Baseline, 4 weeks
  The PRM reflex will be elicited by stimulating the posterior roots of the spinal cord (typically via electrical stimulation of the dorsal roots), and the resulting muscle activity will be recorded using electromyography (EMG)
• Muscle spasticity levels as assessed by the Modified Ashworth Scale (MAS). — Baseline, 4 weeks
  Muscle spasticity will be evaluated using the MAS, which grades the resistance encountered during passive movement of the affected limb (e.g., arm or leg). The scale ranges from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension).
• Muscle Tone (Frequency, Hz) — Baseline, 4 weeks
  This parameter measures the natural oscillation frequency of the muscle in response. It reflects the muscle's state of tension or readiness.
• Elasticity (Dynamic Stiffness, N/m) — Baseline, 4 weeks
  Elasticity, measured in Newtons per meter, reflects the muscle's ability to return to its original shape after being deformed by the impulse
• Stiffness (Decay, ms) — Baseline, 4 weeks
  This parameter quantifies the rate at which the muscle returns to its initial state after the impulse, indicating the muscle's stiffness
• Mechanical Stress (Creep, s) and Relaxation (S) — Baseline, 4 weeks
  These parameters measure the time it takes for muscle tissue to adapt to a sustained force (creep) and the time it takes for the muscle to return to a relaxed state after removing the force (relaxation).

Trial sites (1)

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