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Recruiting NCT06596174

Effect of tSCS on Ankle Movement Training in Individuals With SCI

No phase Interventional SCI - Spinal Cord Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcutaneous spinal cord stimulation (tSCS), Short-term Machine-Assisted Ankle Movement Training with tSCS, Long-term Effects of Machine-Assisted Ankle Movement Training with tSCS.
Who it may be relevant to
Registry conditions: SCI - Spinal Cord Injury. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Latency and amplitude of the H-reflex [Time frame: Baseline, 4 weeks]
  • Latency, amplitude, and duration of the M-wave [Time frame: Baseline, 4 weeks]
  • Level of Post-Activation Depression (PAD) of the H-reflex [Time frame: Baseline, 4 weeks]
  • Latency and amplitude of the Posterior Root Muscle (PRM) reflex [Time frame: Baseline, 4 weeks]
  • Muscle spasticity levels as assessed by the Modified Ashworth Scale (MAS). [Time frame: Baseline, 4 weeks]
  • Muscle Tone (Frequency, Hz) [Time frame: Baseline, 4 weeks]
  • Elasticity (Dynamic Stiffness, N/m) [Time frame: Baseline, 4 weeks]
  • Stiffness (Decay, ms) [Time frame: Baseline, 4 weeks]
  • Mechanical Stress (Creep, s) and Relaxation (S) [Time frame: Baseline, 4 weeks]
Secondary outcome measures (5)
  • Foot pressure distribution and peak pressure. [Time frame: Measured continuously during CPM]
  • The score of 10-meter walking test (10MWT) [Time frame: Baseline, 4 weeks.]
  • Ankle Joint Range of Motion (ROM) [Time frame: Baseline, 4 weeks]
  • Knee Joint ROM [Time frame: Baseline, 4 weeks]
  • Overall the Patient Reported Impact of Spasticity Measure(PRISM) Score [Time frame: Baseline, 4 weeks]

Eligibility criteria

Health subjects:

Exclusion criteria

  • Musculoskeletal injuries on legs.
  • Osteoporosis.

SCI subjects:

Inclusion criteria

1\. 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Taiwan · 1 center
  • Chang Gung University — Taoyuan

Identifiers

NCT: NCT06596174 · SCI_001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗