Clinical trial NCT06596174: Effect of tSCS on Ankle Movement Training in Individuals With SCI
Official title: Effect of tSCS on Ankle Movement Training - Evidence From Spinal Circuitry Adaptation in Individuals With SCI
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: SCI - Spinal Cord Injury
Keywords: post activation depression
transcutaneous spinal cord electrical stimulation (tSCS)
machine-assist therapy
Lead sponsor: Chang Gung University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Latency and amplitude of the H-reflex
timeFrame: Baseline, 4 weeks
measure: Latency, amplitude, and duration of the M-wave
timeFrame: Baseline, 4 weeks
measure: Level of Post-Activation Depression (PAD) of the H-reflex
timeFrame: Baseline, 4 weeks
measure: Latency and amplitude of the Posterior Root Muscle (PRM) reflex
timeFrame: Baseline, 4 weeks
measure: Muscle spasticity levels as assessed by the Modified Ashworth Scale (MAS).
timeFrame: Baseline, 4 weeks
measure: Muscle Tone (Frequency, Hz)
timeFrame: Baseline, 4 weeks
measure: Elasticity (Dynamic Stiffness, N/m)
timeFrame: Baseline, 4 weeks
measure: Stiffness (Decay, ms)
timeFrame: Baseline, 4 weeks
measure: Mechanical Stress (Creep, s) and Relaxation (S)
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Foot pressure distribution and peak pressure.
timeFrame: Measured continuously during CPM
measure: The score of 10-meter walking test (10MWT)
timeFrame: Baseline, 4 weeks.
measure: Ankle Joint Range of Motion (ROM)
timeFrame: Baseline, 4 weeks
measure: Knee Joint ROM
timeFrame: Baseline, 4 weeks
measure: Overall the Patient Reported Impact of Spasticity Measure(PRISM) Score
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Taoyuan
country: Taiwan
facility: Chang Gung University
Study officials:
References: