Effect of tSCS on Ankle Movement Training in Individuals With SCI

Not Applicable

Recruiting

• Conditions: SCI - Spinal Cord Injury
• Interventions: Procedure: Transcutaneous spinal cord stimulation (tSCS); Procedure: Short-term Machine-Assisted Ankle Movement Training with tSCS; Procedure: Long-term Effects of Machine-Assisted Ankle Movement Training with tSCS

• Registration Number: NCT06596174
• Lead Sponsor: Chang Gung University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-11
• Study First Submitted QC: 2024-09-11
• Study First Posted: 2024-09-19
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-24
• Study Start: 2024-11-25
• Last Update Posted: 2024-11-26
• Primary Completion: 2026-08
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stage 1: Healthy people	Transcutaneous spinal cord stimulation (tSCS)	Identify optimal tSCS parameters for non-invasive spinal stimulation.
Stage 2: SCI Patients	Short-term Machine-Assisted Ankle Movement Training with tSCS	Assess the priming effect of tSCS on spinal circuitry during machine-assisted ankle movement training.
Stage 3:SCI Patients	Long-term Effects of Machine-Assisted Ankle Movement Training with tSCS	Long-term clinical effects of combined tSCS and ankle movement training

Primary Outcome Measures

Name	Time	Method
Latency and amplitude of the H-reflex	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.
Latency, amplitude, and duration of the M-wave	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).
Level of Post-Activation Depression (PAD) of the H-reflex	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.
Latency and amplitude of the Posterior Root Muscle (PRM) reflex	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)
Muscle spasticity levels as assessed by the Modified Ashworth Scale (MAS).	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).
Muscle Tone (Frequency, Hz)	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.
Elasticity (Dynamic Stiffness, N/m)	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
Stiffness (Decay, ms)	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
Mechanical Stress (Creep, s) and Relaxation (S)	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 Outcome Measures

Name	Time	Method
Foot pressure distribution and peak pressure.	Measured continuously during CPM	Foot pressure will be measured using pressure sensors during ankle movement
The score of 10-meter walking test (10MWT)	Baseline, 4 weeks.	To measure walking speed over a short distance as a quantitative index of walking ability.
Ankle Joint Range of Motion (ROM)	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.
Knee Joint ROM	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.
Overall the Patient Reported Impact of Spasticity Measure(PRISM) Score	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

Trial Locations

Locations (1)

Chang Gung University; 🇨🇳 Taoyuan, Taiwan