Effect of tSCS on Ankle Movement Training in Individuals With SCI

Effect of tSCS on Ankle Movement Training - Evidence From Spinal Circuitry Adaptation 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.

Study Overview

• Status: Recruiting
• Conditions: SCI - Spinal Cord Injury
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taoyuan, Taiwan, 333
    • Recruiting
    • Chang Gung University
    • Contact: Ya-Ju Chang, PhD; Phone Number: 5515 88632118800; Email: yjchang@mail.cgu.edu.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage 1: Healthy people; Identify optimal tSCS parameters for non-invasive spinal stimulation.	Procedure: Transcutaneous spinal cord stimulation (tSCS); The subjects will undergo 20 minutes transcutaneous spinal cord stimulation (tSCS).
Experimental: Stage 2: SCI Patients; Assess the priming effect of tSCS on spinal circuitry during machine-assisted ankle movement training.	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
Experimental: Stage 3:SCI Patients; Long-term clinical effects of combined tSCS and ankle movement training	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.
No Intervention: Stage 3:SCI Patients(Control); Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 4 weeks
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).	Baseline, 4 weeks
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.	Baseline, 4 weeks
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)	Baseline, 4 weeks
Muscle spasticity levels as assessed by the Modified Ashworth Scale (MAS).	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).	Baseline, 4 weeks
Muscle Tone (Frequency, Hz)	This parameter measures the natural oscillation frequency of the muscle in response. It reflects the muscle's state of tension or readiness.	Baseline, 4 weeks
Elasticity (Dynamic Stiffness, N/m)	Elasticity, measured in Newtons per meter, reflects the muscle's ability to return to its original shape after being deformed by the impulse	Baseline, 4 weeks
Stiffness (Decay, ms)	This parameter quantifies the rate at which the muscle returns to its initial state after the impulse, indicating the muscle's stiffness	Baseline, 4 weeks
Mechanical Stress (Creep, s) and Relaxation (S)	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).	Baseline, 4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Chang Gung University

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: September 11, 2024
• First Submitted That Met QC Criteria: September 11, 2024
• First Posted (Actual): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 24, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: post activation depression; transcutaneous spinal cord electrical stimulation (tSCS); machine-assist therapy
• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Spinal Cord Injuries; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antioxidants; Protective Agents; Anticarcinogenic Agents; Trans-sodium crocetinate
• Other Study ID Numbers: SCI_001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No