Effect of tSCS on Ankle Movement Training in Individuals With SCI

Chang Gung University

Status: Enrolling

Conditions: SCI - Spinal Cord Injury

Treatments: Procedure: Transcutaneous spinal cord stimulation (tSCS); Procedure: Long-term Effects of Machine-Assisted Ankle Movement Training with tSCS; Procedure: Short-term Machine-Assisted Ankle Movement Training with tSCS

Study type: Interventional

Funder types: Other

Identifiers

NCT06596174

SCI_001

Details and patient eligibility

About

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups

Stage 1: Healthy people

Experimental group

Description:

Identify optimal tSCS parameters for non-invasive spinal stimulation.

Treatment:

Procedure: Transcutaneous spinal cord stimulation (tSCS)

Stage 2: SCI Patients

Experimental group

Description:

Assess the priming effect of tSCS on spinal circuitry during machine-assisted ankle movement training.

Treatment:

Procedure: Short-term Machine-Assisted Ankle Movement Training with tSCS

Stage 3:SCI Patients

Experimental group

Description:

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

Treatment:

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

Stage 3:SCI Patients(Control)

No Intervention group

Description:

Control Group