Effect of tSCS on Ankle Movement Training in Individuals With SCI

NCT06596174 | Recruiting

• 1 other identifier: SCI_001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

SCI - Spinal Cord Injury

Keywords

post activation depression; transcutaneous spinal cord electrical stimulation (tSCS); machine-assist therapy

Outcome Measures

Primary Outcomes (9)

• 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 Outcomes (5)

• Foot pressure distribution and peak pressure.

  Measured continuously during CPM

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

  Baseline, 4 weeks.

• Ankle Joint Range of Motion (ROM)

  Baseline, 4 weeks

• Knee Joint ROM

  Baseline, 4 weeks

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

  Baseline, 4 weeks

Study Arms (4)

Stage 1: Healthy people

EXPERIMENTAL

Identify optimal tSCS parameters for non-invasive spinal stimulation.

Procedure: Transcutaneous spinal cord stimulation (tSCS)

Stage 2: SCI Patients

EXPERIMENTAL

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

Stage 3:SCI Patients

EXPERIMENTAL

Long-term clinical effects of combined tSCS and ankle movement training

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

Stage 3:SCI Patients(Control)

NO INTERVENTION

Control Group

Interventions

Transcutaneous spinal cord stimulation (tSCS) PROCEDURE

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

Stage 1: Healthy people

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

Stage 2: SCI Patients

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.

Stage 3:SCI Patients

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Musculoskeletal injuries on legs.
• Osteoporosis.
• SCI subjects:
• \. Participants with chronic spinal cord injury, with injury duration greater than one year.
• 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.

Sponsors & Collaborators

• Chang Gung University: lead

Study Sites (1)

Chang Gung University

Taoyuan District, 333, Taiwan

RECRUITING

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 11, 2024
• First Posted: September 19, 2024
• Study Start: November 25, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

TW (1)