Health TrialsbyHealthPanel

Effect of tSCS on Ankle Movement Training in Individuals With SCI

ConditionSCI - Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20+
SponsorChang Gung University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Musculoskeletal injuries on legs.

Osteoporosis.

Current musculoskeletal or joint injuries in the lower limbs.

History of central or peripheral neuromuscular diseases.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transcutaneous spinal cord stimulation (tSCS)

    Procedure/Surgery

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

  • Short-term Machine-Assisted Ankle Movement Training with tSCS

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

80 Participants
are divided into 4 treatment groups
Group A: Stage 1: Healthy peopleExperimental treatment 1 intervention
Group B: Stage 2: SCI PatientsExperimental treatment 1 intervention
Group C: Stage 3:SCI PatientsExperimental treatment 1 intervention
Group D: Stage 3:SCI Patients(Control)No intervention 0 interventions

Trial outcomes

Primary outcomes

1

Latency and amplitude of the H-reflex

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.

Time frame
Baseline, 4 weeks
2

Latency, amplitude, and duration of the M-wave

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).

Time frame
Baseline, 4 weeks
3

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

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.

Time frame
Baseline, 4 weeks
4

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

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)

Time frame
Baseline, 4 weeks

Secondary outcomes

1

Foot pressure distribution and peak pressure.

Foot pressure will be measured using pressure sensors during ankle movement

Time frame
Measured continuously during CPM
2

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

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

Time frame
Baseline, 4 weeks.
3

Ankle Joint Range of Motion (ROM)

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.

Time frame
Baseline, 4 weeks
4

Knee Joint ROM

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.

Time frame
Baseline, 4 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Chang Gung University

Lead sponsor

Source ClinicalTrials.gov
Apply now