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NCT Number: NCT06596174

Effect of tSCS on Ankle Movement Training in Individuals With SCI

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.

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Key information

Conditions

SCI - Spinal Cord Injury Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Trauma, Nervous System Wounds and Injuries

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung University

Taoyuan, 333, Taiwan

Location status: Recruiting

Location contact

Ya-Ju Chang, PhD

CONTACT

[email protected]

88632118800 ext. 5515

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Health subjects:

Exclusion criteria

  • 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.

Treatment and study plan

Transcutaneous spinal cord stimulation (tSCS)

Procedure

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

Short-term Machine-Assisted Ankle Movement Training with tSCS

Procedure

The subjects will undergo 30 minutes of machine-assisted ankle movement training combined with transcutaneous spinal cord stimulation (tSCS) at a time

Long-term Effects of Machine-Assisted Ankle Movement Training with tSCS

Procedure

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 outcomes

  1. Latency and amplitude of the H-reflex

    Time frame: Baseline, 4 weeks

    The H-reflex will be elicited through electrical stimulation of the tibial nerve (or sciatic nerve) using electromyography (EMG) to record the resulting muscle response.

  2. Latency, amplitude, and duration of the M-wave

    Time frame: Baseline, 4 weeks

    The M-wave will be elicited by direct electrical stimulation of the motor nerve (e.g., tibial nerve) and recorded using electromyography (EMG) from the target muscle (e.g., soleus muscle).

  3. Level of Post-Activation Depression (PAD) of the H-reflex

    Time frame: Baseline, 4 weeks

    The H-reflex will be elicited by electrical stimulation of the tibial nerve (or other motor nerves), and PAD will be assessed by measuring the reduction in H-reflex amplitude following a series of repetitive stimuli. The amplitude of the H-reflex after repeated stimulation will be compared to the baseline single stimulus.

  4. Latency and amplitude of the Posterior Root Muscle (PRM) reflex

    Time frame: Baseline, 4 weeks

    The PRM reflex will be elicited by stimulating the posterior roots of the spinal cord (typically via electrical stimulation of the dorsal roots), and the resulting muscle activity will be recorded using electromyography (EMG)

  5. Muscle spasticity levels as assessed by the Modified Ashworth Scale (MAS).

    Time frame: Baseline, 4 weeks

    Muscle spasticity will be evaluated using the MAS, which grades the resistance encountered during passive movement of the affected limb (e.g., arm or leg). The scale ranges from 0 (no increase in muscle tone) to 4 (affected part rigid in flexion or extension).

  6. Muscle Tone (Frequency, Hz)

    Time frame: Baseline, 4 weeks

    This parameter measures the natural oscillation frequency of the muscle in response. It reflects the muscle's state of tension or readiness.

  7. Elasticity (Dynamic Stiffness, N/m)

    Time frame: Baseline, 4 weeks

    Elasticity, measured in Newtons per meter, reflects the muscle's ability to return to its original shape after being deformed by the impulse

  8. Stiffness (Decay, ms)

    Time frame: Baseline, 4 weeks

    This parameter quantifies the rate at which the muscle returns to its initial state after the impulse, indicating the muscle's stiffness

  9. Mechanical Stress (Creep, s) and Relaxation (S)

    Time frame: Baseline, 4 weeks

    These parameters measure the time it takes for muscle tissue to adapt to a sustained force (creep) and the time it takes for the muscle to return to a relaxed state after removing the force (relaxation).

Secondary outcomes

  1. Foot pressure distribution and peak pressure.

    Time frame: Measured continuously during CPM

    Foot pressure will be measured using pressure sensors during ankle movement

  2. The score of 10-meter walking test (10MWT)

    Time frame: Baseline, 4 weeks.

    To measure walking speed over a short distance as a quantitative index of walking ability.

  3. Ankle Joint Range of Motion (ROM)

    Time frame: Baseline, 4 weeks

    These movements measure the ability to move the foot up towards the shin (dorsiflexion) and down away from the body (plantarflexion). Typical instruments used include a universal goniometer or an inclinometer. The patient is typically seated or lying down with the knee extended for accurate measurement.

  4. Knee Joint ROM

    Time frame: Baseline, 4 weeks

    These are the primary movements of the knee, involving bending (flexion) and straightening (extension) of the leg. Measurements are taken with the patient seated or lying down. A goniometer is placed on the lateral aspect of the knee to record the angle of maximum bend and extension.

  5. Overall the Patient Reported Impact of Spasticity Measure(PRISM) Score

    Time frame: Baseline, 4 weeks

    An aggregated score derived from all the individual items within the questionnaire, providing a comprehensive measure of the impact of spasticity on the patient's quality of life

Sponsors and collaborators

Lead sponsor

Chang Gung University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 19, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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