SCI - Spinal Cord InjuryNCT06596174
Effect of tSCS on Ankle Movement Training in Individuals With SCI
A study testing Transcutaneous spinal cord stimulation (tSCS), Short-term Machine-Assisted Ankle Movement Training with tSCS and Long-term Effects of Machine-Assisted Ankle Movement Training with tSCS in people with SCI - Spinal Cord Injury, run by Chang Gung University at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- SCI - Spinal Cord Injury
- What is being tested?
- Transcutaneous spinal cord stimulation (tSCS), Short-term Machine-Assisted Ankle Movement Training with tSCS and Long-term Effects of Machine-Assisted Ankle Movement Training with tSCS
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Nov 2024to Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1. Participants with chronic spinal cord injury, with injury duration greater than one year.
Who cannot join
- Musculoskeletal injuries on legs.
- Osteoporosis.
- SCI subjects:
- Current musculoskeletal or joint injuries in the lower limbs.
- History of central or peripheral neuromuscular diseases.
- Presence of a pacemaker.
Show all 9Show fewer
- Current use of antispastic or antidepressant medications.
- Current venous thromboembolism or osteoporosis.
- Impairment of the soleus H-reflex arc.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site, 1 recruiting
- Recruiting
Chang Gung University
Taoyuan, 333
Ya-Ju Chang, PhD, 88632118800 ext. 5515, yjchang@mail.cgu.edu.tw
About this study
Official title: 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:
Read more
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
- Being tested
- Transcutaneous spinal cord stimulation (tSCS), Short-term Machine-Assisted Ankle Movement Training with tSCS, Long-term Effects of Machine-Assisted Ankle Movement Training with tSCS
- Keywords
- post activation depression, transcutaneous spinal cord electrical stimulation (tSCS), machine-assist therapy
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous spinal cord stimulation (tSCS)Procedure or surgery
The subjects will undergo 20 minutes transcutaneous spinal cord stimulation (tSCS).
Short-term Machine-Assisted Ankle Movement Training with tSCSProcedure or surgery
The subjects will undergo 30 minutes of machine-assisted ankle movement training combined with transcutaneous spinal cord stimulation (tSCS) at a time
Long-term Effects of Machine-Assisted Ankle Movement Training with tSCSProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1: Healthy people | Experimental | Identify optimal tSCS parameters for non-invasive spinal stimulation. Receives: 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. Receives: 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 Receives: Procedure: Long-term Effects of Machine-Assisted Ankle Movement Training with tSCS |
| Stage 3:SCI Patients(Control) | No intervention | Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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.
Measured: 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)
Measured: 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).
Measured: 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.
Measured: 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
Measured: 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
Measured: 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).
Measured: Baseline, 4 weeks
Secondary outcomes (5)
Foot pressure distribution and peak pressure.
Foot pressure will be measured using pressure sensors during ankle movement
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start25 Nov 2024
- Primary completionAug 2026 (estimated)
- Study completionAug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SCI - Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Ju Chang, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06596174
- Sponsor's protocol ID
- SCI_001
- Status last verified
- Nov 2024
- First submitted
- 11 Sep 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of tSCS on Ankle Movement Training - Evidence From Spinal Circuitry Adaptation in Individuals With SCI
- ClinicalTrials.gov ID
- NCT06596174
- Acronym / sponsor ID
- SCI_001
- Conditions
- SCI - Spinal Cord Injury
- Keywords
- post activation depression, transcutaneous spinal cord electrical stimulation (tSCS), machine-assist therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- 25 Nov 2024 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Stage 1: Healthy people | Experimental | Procedure: Transcutaneous spinal cord stimulation (tSCS)Identify optimal tSCS parameters for non-invasive spinal stimulation. |
| Stage 2: SCI Patients | Experimental | Procedure: Short-term Machine-Assisted Ankle Movement Training with tSCSAssess the priming effect of tSCS on spinal circuitry during machine-assisted ankle movement training. |
| Stage 3:SCI Patients | Experimental | Procedure: Long-term Effects of Machine-Assisted Ankle Movement Training with tSCSLong-term clinical effects of combined tSCS and ankle movement training |
| Stage 3:SCI Patients(Control) | No intervention | –Control Group |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Participants with chronic spinal cord injury, with injury duration greater than one year.
Key exclusion criteria (9 listed)
- Musculoskeletal injuries on legs.
- Osteoporosis.
- Current musculoskeletal or joint injuries in the lower limbs.
- History of central or peripheral neuromuscular diseases.
- Presence of a pacemaker.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcutaneous spinal cord stimulation (tSCS)The subjects will undergo 20 minutes transcutaneous spinal cord stimulation (tSCS). | Procedure or surgery | Stage 1: Healthy people |
| Short-term Machine-Assisted Ankle Movement Training with tSCSThe subjects will undergo 30 minutes of machine-assisted ankle movement training combined with transcutaneous spinal cord stimulation (tSCS) at a time | Procedure or surgery | Stage 2: SCI Patients |
| Long-term Effects of Machine-Assisted Ankle Movement Training with tSCSThe 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. | Procedure or surgery | Stage 3:SCI Patients |
Primary outcome
Latency and amplitude of the H-reflex
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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).
5 secondary outcomes
Foot pressure distribution and peak pressure.
Time frame: Measured continuously during CPM
The score of 10-meter walking test (10MWT)
Time frame: Baseline, 4 weeks.
Ankle Joint Range of Motion (ROM)
Time frame: Baseline, 4 weeks
Knee Joint ROM
Time frame: Baseline, 4 weeks
Overall the Patient Reported Impact of Spasticity Measure(PRISM) Score
Time frame: Baseline, 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcutaneous spinal cord stimulation (tSCS), Short-term Machine-Assisted Ankle Movement Training with tSCS and Long-term Effects of Machine-Assisted Ankle Movement Training with tSCS in people with SCI - Spinal Cord Injury, run by Chang Gung University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Latency and amplitude of the H-reflex (time frame: Baseline, 4 weeks). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.