Spinal Cord InjurytSCScwRTNCT07907952
tSCS Combined With Rehabilitation Training in Treating Paraplegic Patients After SCI
A study testing Transcutaneous Spinal Cord Stimulation Combined with Rehabilitation Training in people with Spinal Cord Injury and Paraplegia, Spinal, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
Trial summary
This clinical trial aims to evaluate the safety and efficacy of transcutaneous spinal cord stimulation (tSCS) combined with rehabilitation training for treating paraplegia after spinal cord injury (SCI). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Spinal Cord Injury, Paraplegia, Spinal
- What is being tested?
- Transcutaneous Spinal Cord Stimulation Combined with Rehabilitation Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Dec 2027
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years old;
- Spinal cord injury classified as AIS Grade A, B, C, or D, with the distance between the injury level and the conus medullaris at least 60mm
- Able to cooperate with rehabilitation training;
- Stable and healthy physiological condition, as determined by the researcher; must be able to complete the entire study period and cooperate with rehabilitation training.
Who cannot join
- 1. Obvious mental disorders (anxiety, depression, etc.) resulting in inability to complete relevant subjective assessments2. Presence of mental or cognitive impairments preventing participation in transcutaneous spinal electrical stimulation and follow-up3. Severe autonomic reflex disorders4. Severe muscle atrophy or joint contractures5. Life expectancy less than 1 year6. Progressive spinal instability or severe spinal deformities7. Uncontrolled hypertension, severe heart disease, or serious medical/respiratory conditions8. Severe hydronephrosis or renal dysfunction9. Individuals considered unsuitable by the researcher
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Beijing Tsinghua Chang Gung Hospital
Beijing
010-56112345 ext. +86, office@btch.edu.cn
About this study
Official title: Clinical Trial on the Safety and Efficacy of Transcutaneous Spinal Cord Stimulation Combined With Rehabilitation Training in the Treatment of Paraplegic Patients After Spinal Cord Injury
This clinical trial aims to evaluate the safety and efficacy of transcutaneous spinal cord stimulation (tSCS) combined with rehabilitation training for treating paraplegia after spinal cord injury (SCI). Previous studies have shown that applying tSCS in the thoracolumbar region can enable patients with complete and incomplete SCI to immediately restore partial voluntary movement, but there are currently no domestic reports on the treatment of SCI paraplegia using tSCS combined with rehabilitation training. The main questions this study aims to answer include: 1. Compared with using tSCS alone, does combined rehabilitation therapy enable patients to better restore voluntary movement? 2. Will this treatment protocol result in fewer adverse events? 3. Can the tSCS combined with rehabilitation training protocol be applied to a large number of patients with paraplegia after SCI to help them restore voluntary movement?For paraplegic patients with SCI (spinal cord injury) whose injury duration exceeds 1 week, baseline data (pre-stimulation, at the end of the first week of stimulation, and post-experiment) need to be collected after assessment. After adjusting the stimulation parameters of tSCS (transcutaneous spinal cord stimulation) and modifying the rehabilitation training plan, a one-month personalized rehabilitation training program will be conducted, followed by at least four weeks of follow-up. Researchers will compare the assessment results recorded at different stages and use specific indicators to evaluate the safety and effectiveness of this treatment protocol.
- Conditions
- Spinal Cord Injury, Paraplegia, Spinal
- Being tested
- Transcutaneous Spinal Cord Stimulation Combined with Rehabilitation Training
- Keywords
- Transcutaneous Spinal Cord Stimulation, Rehabilitation Training, Spinal Cord Injury, paraplegia
- Medical subject headings
- Spinal Cord Injuries, Paraplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcutaneous Spinal Cord Stimulation Combined with Rehabilitation TrainingOther
For paraplegic patients with SCI (spinal cord injury) whose injury duration exceeds 1 week, baseline data (pre-stimulation, at the end of week 1 of stimulation, and post-experiment) need to be collected after assessment. After adjusting the stimulation parameters of tSCS (transcutaneous spinal cord stimulation) and modifying the rehabilitation training plan, a one-month personalized rehabilitation training program will be conducted, followed by at least four weeks of follow-up.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous Spinal Cord Stimulation Combined with Rehabilitation Training | Experimental | Not described Receives: Other: Transcutaneous Spinal Cord Stimulation Combined with Rehabilitation Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Walking Index for Spinal Cord Injury, WISCI Ⅱ
The commonly used ordinal scale in clinical trials to measure walking ability in patients with spinal cord injury. Based on the severity of walking impairment, the walking function is divided into 21 levels (from level 0, where patients cannot stand or walk, to level 20, where patients can walk at least 10 meters without facilities or assistance) based on the equipment, braces, and assistance required for patients to walk 10 meters.
Measured: Baseline、Week 1 of Stimulation and Completion of experiment
10-Meter Walk Test, 10MWT
Walking speed test: measures the time required for patients to walk 10 meters, used to assess their short-distance walking ability.
Measured: Baseline、Week 1 of Stimulation and Completion of experiment
Weight Bearing Capacity, WBC
It is a crucial outcome that requires monitoring, especially for patients with severe motor disorders who are unable to walk independently.
Measured: Baseline、Week 1 of Stimulation and Completion of experiment
Secondary outcomes (4)
Berg Balance Scale, BBS
Used for clinical assessment of balance function. The assessment includes 14 items, with each item scored from 0 to 4 points, resulting in a total score of 56 points. The scores are divided into three groups: 0-20, 21-40, and 41-56, which correspond to three activity states: wheelchair use, assisted walking, and independent walking. If the total score is less than 40 points, it indicates a risk of falling.
Measured: Baseline、Week 1 of Stimulation and Completion of experiment
36-Item Short Form Health Survey，SF-36
Including 36 items divided into 8 dimensions: physiological function, role-physical, bodily pain, general health, vitality, social function, role-emotional, and mental health. These dimensions belong to two major categories: physical health and mental health. The final score for each dimension ranges from 0 (lowest) to 100 (highest), with higher scores indicating better quality of life.
Measured: Baseline、Week 1 of Stimulation and Completion of experiment
6-Min Walk Test, 6MWT
The walking speed test, which measures the distance a patient can walk in 6 minutes, reflects the overall functional status of the cardiorespiratory and musculoskeletal systems in daily activities.
Measured: Baseline、Week 1 of Stimulation and Completion of experiment
Kinematic Assessment
The three-dimensional motion capture system is used to obtain kinematic records (gait temporal parameters, spatial parameters; hip, knee, and ankle joint angles) of patients during walking. The system's infrared cameras capture human kinematics by using infrared reflective markers placed on anatomical landmarks. High-definition cameras are used to capture patients' timing photographic images, which demonstrate the dynamics of patient movement through superimposed consecutive snapshots.
Measured: Baseline、Week 1 of Stimulation and Completion of experiment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2026
- Study start1 Dec 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Beijing Tsinghua Chang Gung HospitalThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Tsinghua Chang Gung Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yang Lu, Beijing Tsinghua Chang Gung Hospital
- Investigators
- Yang Lu, Principal investigator, Beijing Tsinghua Chang Gung Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07907952
- Sponsor's protocol ID
- 20241128
- Acronym
- tSCScwRT
- Status last verified
- Jan 2026
- First submitted
- 26 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Safety and Efficacy of Transcutaneous Spinal Cord Stimulation Combined With Rehabilitation Training in the Treatment of Paraplegic Patients After Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07907952
- Acronym / sponsor ID
- tSCScwRT / 20241128
- Conditions
- Spinal Cord Injury, Paraplegia, Spinal
- Keywords
- Transcutaneous Spinal Cord Stimulation, Rehabilitation Training, Spinal Cord Injury, paraplegia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Beijing Tsinghua Chang Gung HospitalUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Oct 2026 (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 aims to evaluate the safety and efficacy of transcutaneous spinal cord stimulation (tSCS) combined with rehabilitation training for treating paraplegia after spinal cord injury (SCI). Previous studies have shown that applying tSCS in the thoracolumbar region can enable patients with complete and incomplete SCI to immediately restore partial voluntary movement, but there are currently no domestic reports on the treatment of SCI paraplegia using tSCS combined with rehabilitation training. The main questions this study aims to answer include: 1. Compared with using tSCS alone, does combined rehabilitation therapy enable patients to better restore voluntary movement? 2. Will this treatment protocol result in fewer adverse events? 3. Can the tSCS combined with rehabilitation training protocol be applied to a large number of patients with paraplegia after SCI to help them restore voluntary movement?For paraplegic patients with SCI (spinal cord injury) whose injury duration exceeds 1 week, baseline data (pre-stimulation, at the end of the first week of stimulation, and post-experiment) need to be collected after assessment. After adjusting the stimulation parameters of tSCS (transcutaneous spinal cord stimulation) and modifying the rehabilitation training plan, a one-month personalized rehabilitation training program will be conducted, followed by at least four weeks of follow-up. Researchers will compare the assessment results recorded at different stages and use specific indicators to evaluate the safety and effectiveness of this treatment protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous Spinal Cord Stimulation Combined with Rehabilitation Training | Experimental | Other: Transcutaneous Spinal Cord Stimulation Combined with Rehabilitation Training |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 60 years old;
- Spinal cord injury classified as AIS Grade A, B, C, or D, with the distance between the injury level and the conus medullaris at least 60mm
- Able to cooperate with rehabilitation training;
- Stable and healthy physiological condition, as determined by the researcher; must be able to complete the entire study period and cooperate with rehabilitation training.
Key exclusion criteria (1 listed)
- 1. Obvious mental disorders (anxiety, depression, etc.) resulting in inability to complete relevant subjective assessments2. Presence of mental or cognitive impairments preventing participation in transcutaneous spinal electrical stimulation and follow-up3. Severe autonomic reflex disorders4. Severe muscle atrophy or joint contractures5. Life expectancy less than 1 year6. Progressive spinal instability or severe spinal deformities7. Uncontrolled hypertension, severe heart disease, or serious medical/respiratory conditions8. Severe hydronephrosis or renal dysfunction9. Individuals considered unsuitable by the researcher
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 Combined with Rehabilitation TrainingFor paraplegic patients with SCI (spinal cord injury) whose injury duration exceeds 1 week, baseline data (pre-stimulation, at the end of week 1 of stimulation, and post-experiment) need to be collected after assessment. After adjusting the stimulation parameters of tSCS (transcutaneous spinal cord stimulation) and modifying the rehabilitation training plan, a one-month personalized rehabilitation training program will be conducted, followed by at least four weeks of follow-up. | Other | Transcutaneous Spinal Cord Stimulation Combined with Rehabilitation Training |
Primary outcome
Walking Index for Spinal Cord Injury, WISCI Ⅱ
Time frame: Baseline、Week 1 of Stimulation and Completion of experiment
The commonly used ordinal scale in clinical trials to measure walking ability in patients with spinal cord injury. Based on the severity of walking impairment, the walking function is divided into 21 levels (from level 0, where patients cannot stand or walk, to level 20, where patients can walk at least 10 meters without facilities or assistance) based on the equipment, braces, and assistance required for patients to walk 10 meters.
10-Meter Walk Test, 10MWT
Time frame: Baseline、Week 1 of Stimulation and Completion of experiment
Walking speed test: measures the time required for patients to walk 10 meters, used to assess their short-distance walking ability.
Weight Bearing Capacity, WBC
Time frame: Baseline、Week 1 of Stimulation and Completion of experiment
It is a crucial outcome that requires monitoring, especially for patients with severe motor disorders who are unable to walk independently.
4 secondary outcomes
Berg Balance Scale, BBS
Time frame: Baseline、Week 1 of Stimulation and Completion of experiment
36-Item Short Form Health Survey，SF-36
Time frame: Baseline、Week 1 of Stimulation and Completion of experiment
6-Min Walk Test, 6MWT
Time frame: Baseline、Week 1 of Stimulation and Completion of experiment
Kinematic Assessment
Time frame: Baseline、Week 1 of Stimulation and Completion of experiment
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 30 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Yang Lu principal investigator
Beijing Tsinghua Chang Gung Hospital
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 Combined with Rehabilitation Training in people with Spinal Cord Injury and Paraplegia, Spinal, run by Beijing Tsinghua Chang Gung Hospital at 1 site in China.
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 4 inclusion and 1 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 30 Oct 2026. 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 China. 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?
Contact Yang Lu, MD (+8656119530, yanglu@btch.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking Index for Spinal Cord Injury, WISCI Ⅱ (time frame: Baseline、Week 1 of Stimulation and Completion of experiment). The study lists 3 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 30 Oct 2026.