Actively Recruiting
Effect of Transcutaneous Spinal Cord Stimulation on Ankle Movement Training and Spinal Circuitry Adaptation in Individuals With Spinal Cord Injury
Led by Chang Gung University · Updated on 2024-11-26
80
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of transcutaneous spinal cord stimulation (tSCS), a non-invasive method, on spinal circuitry adaptation in people with spinal cord injury (SCI). The trial aims to find the best tSCS settings for spinal stimulation, explore how tSCS enhances spinal function during machine-assisted ankle movement training, and study the long-term results of combining tSCS with ankle training. Both healthy individuals and those with complete or incomplete SCI will participate to better understand spinal re-adaptation. Participants will receive different interventions depending on their group. Healthy volunteers undergo tSCS sessions lasting 20 minutes. Those with SCI participate in machine-assisted ankle movement training combined with tSCS for 30 minutes per session. The long-term treatment involves three 30-minute sessions per week over four weeks. A control group of SCI patients will not receive the intervention, allowing comparison of outcomes. Throughout the study, researchers will assess spinal reflexes using measures like the H-reflex and M-wave, muscle spasticity, tone, elasticity, stiffness, and mechanical stress at the start and after four weeks. Additional evaluations include foot pressure, walking tests, joint motion range, and patient-reported spasticity impact. These assessments help track spinal circuitry changes and muscle function. The study is randomized and runs until August 2026.
CONDITIONS
Brief Title
Effect of tSCS on Ankle Movement Training in Individuals With SCI
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 20 years or older
- Participants with chronic spinal cord injury lasting more than one year (for SCI subjects)
- Healthy volunteers without musculoskeletal injuries (for healthy subjects)
You will not qualify if you...
- Musculoskeletal injuries on legs
- Osteoporosis
- Current musculoskeletal or joint injuries in the lower limbs (for SCI subjects)
- 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 (for SCI subjects)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Single session
Participants undergo 30 minutes of machine-assisted ankle movement training combined with transcutaneous spinal cord stimulation (tSCS) at a time.
1 visit (in-person)
Duration - 4 weeks
Participants undergo machine-assisted ankle movement training combined with transcutaneous spinal cord stimulation (tSCS). Each session lasts for 30 minutes, conducted three times per week, over a period of four weeks.
Three visits per week for 4 weeks
Trial Site Locations
Total: 1 location
1
Chang Gung University
Taoyuan, Taiwan, 333
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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