Effect of tSCS on Ankle Movement Training in Individuals With SCI

Recruiting now · Not applicable

Conditions studied: SCI - Spinal Cord Injury

In brief

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.

Key facts

Study ID

NCT06596174

Run by

Chang Gung University

People needed

80

Starts

2024-11-25

Expected to finish

2026-08-01

Last updated by the study team

2024-11-26

Who can join

Age: 20 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Participants with chronic spinal cord injury, with injury duration greater than one year.
• Exclusion Criteria
• 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.

You may not qualify if…

• Musculoskeletal injuries on legs.
• Osteoporosis.
• SCI subjects:
• Inclusion Criteria
• Participants with chronic spinal cord injury, with injury duration greater than one year.
• Exclusion Criteria
• 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.

Where it is running

• Chang Gung University — Taoyuan, Taiwan (enrolling)

Full record on ClinicalTrials.gov

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