Effect of tSCS on Ankle Movement Training in Individuals With SCI

Recruiting · NCT06596174 · Interventional (participants receive a specific treatment) · Lead sponsor: Chang Gung University

View the official record on ClinicalTrials.gov →

Depression

Interventions studied

Long-term Effects of Machine-Assisted Ankle Movement Training with tSCSShort-term Machine-Assisted Ankle Movement Training with tSCSTranscutaneous spinal cord stimulation (tSCS)

What this trial is about

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.

Who can take part

Age range

20 Years and older

Sex

All (male and female)

Healthy volunteers

Yes - healthy volunteers may be accepted

Phase

Not applicable (e.g. observational or device study)

Study type

Interventional (participants receive a specific treatment)

Eligibility criteria (as published)

Health subjects: Exclusion Criteria: 1. Musculoskeletal injuries on legs. 2. Osteoporosis. SCI subjects: Inclusion Criteria 1\. Participants with chronic spinal cord injury, with injury duration greater than one year. Exclusion Criteria 1. Current musculoskeletal or joint injuries in the lower limbs. 2. History of central or peripheral neuromuscular diseases. 3. Presence of a pacemaker. 4. Current use of antispastic or antidepressant medications. 5. Current venous thromboembolism or osteoporosis. 6. Impairment of the soleus H-reflex arc.

Where it is running

1 location listed.

Chang Gung University - Taoyuan, Taiwan

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →