RecruitingNot ApplicableNCT06596174

Effect of tSCS on Ankle Movement Training in Individuals With SCI

Effect of tSCS on Ankle Movement Training - Evidence From Spinal Circuitry Adaptation in Individuals With SCI


Sponsor

Chang Gung University

Enrollment

80 participants

Start Date

Nov 25, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 20 Years

Inclusion Criteria2

  • Health subjects:
  • \. Participants with chronic spinal cord injury, with injury duration greater than one year.

Exclusion Criteria9

  • Musculoskeletal injuries on legs.
  • Osteoporosis.
  • SCI subjects:
  • Current musculoskeletal or joint injuries in the lower limbs.
  • History of central or peripheral neuromuscular diseases.
  • Presence of a pacemaker.
  • Current use of antispastic or antidepressant medications.
  • Current venous thromboembolism or osteoporosis.
  • Impairment of the soleus H-reflex arc.

Interventions

PROCEDURETranscutaneous spinal cord stimulation (tSCS)

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

PROCEDUREShort-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

PROCEDURELong-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.


Locations(1)

Chang Gung University

Taoyuan District, Taiwan

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NCT06596174


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