Spinal Cord InjuriesNCT06455137
Epidural Electrical Stimulation for Spinal Cord Injury Patients and Corticospinal Motor Circuit Improvement
A study testing Epidural Stimulator in people with Spinal Cord Injuries, run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
The study aims to examine the plausible interventional mechanisms underlying the effects of epidural spinal cord stimulation. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Epidural Stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Apr 2024to 31 Dec 2029
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- SCI ASIA: A, B, C,D
- Between 20 and 70 year of age
- >1 year post SCI
- Complete or incomplete spinal cord injury.
- Expected will undergo spinal cord stimulation surgery.
- Continued rehabilitation after surgery for spinal cord injury.
- Able to comply with procedures and follow up.
- Stable medical condition without cardiopulmonary disease or dysautonomia that would - contraindicate participation in lower extremity rehabilitation or testing activities
Who cannot join
- Have significant cognitive impairment (MMSE<24).
- Had a mental illness within one year or been treated in the past.
- Have Major depressive disorder.
- Active cancer diagnosis.
- Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training.
- Cardiovascular or musculoskeletal disease or injury that would prevent full participation in physical therapy intervention.
- Unable to read and/or comprehend the consent form.
- Have concerns about this trial and do not sign consent.
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
Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital
Hualien City, 970
Sheng-Tzung Tsai, M.D., Ph.D., +886-3-856-1825 ext. 13054, flydream.tsai@gmail.com
Yu-Chen Chen, +886-3-856-1825 ext. 13054, spring810569@gmail.com
About this study
The study aims to examine the plausible interventional mechanisms underlying the effects of epidural spinal cord stimulation.
Read the detailed description
The purpose of this study is for the treatment of spinal cord injury (SCI) paralysis patients use the signal by electrophysiological analysis of epidural spinal cord stimulation (SCS) settings that promote limbs activity so that SCI patients can restore motor ability under multiple sensory stimuli and multimodal electrical stimulation rehabilitation. The investigators hope to establish an atresia nerve regulation strategy and observe that the original blocked neural circuits can improve nerve plasticity by SCS. Even can establish new connections through residual nerves and allow SCI patients to rebuild neural circuits without SCS to restore limbs mobility and improve quality of life.
- Conditions
- Spinal Cord Injuries
- Being tested
- Epidural Stimulator
- 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.
Epidural StimulatorDevice
Participants will have a 16-electrode epidural array implanted in the C4-C7 and T11-L2 areas of the spinal cord. Following a 2 weeks recovery period, patients will engage in a structured training of physical rehabilitation and electrical stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Epidural Stimulator | Experimental | Participants will have a 16-electrode epidural array implanted in the C4-C7 and T11-L2 areas of the spinal cord. Following a 2 weeks recovery period, patients will engage in a structured training of physical rehabilitation and electrical stimulation. Receives: Device: Epidural Stimulator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Electroencephalography and Electromyography
To measure activity in the brain
Measured: To measure assessing change between pre-implant and every 3 months until 24 months.
Electromyographic analysis
Average of 5-repetitive EMG activity for each superficial component of muscles from a five-second ramp contraction to the end of a ten-second rest
Measured: To measure assessing change between pre-implant and every 3 months until 24 months.
Single transcranial magnetic stimulation
To evaluate the function of corticospinal tract nerve conduction
Measured: To measure assessing change between pre-implant and every 3 months until 24 months.
Motion Analysis
To evaluate the angles that can be achieved at each joint of the upper limbs
Measured: To measure assessing change between pre-implant and every 3 months until 24 months.
Functional Test
To evaluate gait for subjects who can walk by assistive device or independently
Measured: To measure assessing change between pre-implant and every 3 months until 24 months.
Secondary outcomes (9)
American Spinal Injury Association (ASIA-2019) Impairment Scale
To measure and record disease history
In simpler terms, it's a 5-point scale that categorizes individuals from "A" (complete spinal cord injury) to "E" (normal sensory and motor function), with each letter representing a different level of injury severity:
A: Complete spinal cord injury. B: Sensory incomplete injury. C: Motor incomplete injury. D: Motor incomplete injury. E: Normal sensory and motor function.
Measured: To measure assessing change between pre-implant and every 3 months until 24 months.
Modified Ashworth scale
To measure the increase of muscle tone,it uses a 6-point system. Scores range from 0 to 4. Lower scores indicate normal muscle tone, while higher scores indicate spasticity or increased resistance to passive movement.
Measured: To measure assessing change between pre-implant and every 3 months until 24 months.
Barthel Index
To measure performance in activities of daily living
Measured: To measure assessing change between pre-implant and every 3 months until 24 months.
World Health Organization Quality of Life Brief Version
A brief version scale of World Health Organization Quality-of-Life scale
Measured: To measure assessing change between pre-implant and every 3 months until 24 months.
Spinal Cord Independence Measure
To measure performance in activities of daily living and mobility
Measured: To measure assessing change between pre-implant and every 3 months until 24 months.
Box and Block Test
To measure unilateral gross manual dexterity.
Measured: To measure assessing change between pre-implant and every 3 months until 24 months.
Action Research Arm Test Scoring Sheet
To measures upper limb function by scoring the ability to complete functional tasks.
Measured: To measure assessing change between pre-implant and every 3 months until 24 months.
Berg Balance Scale
To measure balance and the risk of falls,it's a list of 14 things to rate, where each thing has a scale from 0 to 4. Zero means the lowest function, while four means the highest function.
Measured: To measure assessing change between pre-implant and every 3 months until 24 months.
Walking Index for Spinal Cord Injury II (WISCI II- March 2005)
To measure walking ability for spinal cord injury.
Measured: To measure assessing change between pre-implant and every 3 months until 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start30 Apr 2024
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Buddhist Tzu Chi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sheng-Tzung Tsai, M.D., Ph.D., Principal investigator, Hualien Tzu Chi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455137
- Sponsor's protocol ID
- IRB112-067-A
- Status last verified
- Sep 2025
- First submitted
- 7 Jun 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidural Electrical Stimulation for Spinal Cord Injury Patients and Corticospinal Motor Circuit Improvement
- ClinicalTrials.gov ID
- NCT06455137
- Acronym / sponsor ID
- IRB112-067-A
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 30 Apr 2024 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 12 Jun 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.
The study aims to examine the plausible interventional mechanisms underlying the effects of epidural spinal cord stimulation.
Detailed description
The purpose of this study is for the treatment of spinal cord injury (SCI) paralysis patients use the signal by electrophysiological analysis of epidural spinal cord stimulation (SCS) settings that promote limbs activity so that SCI patients can restore motor ability under multiple sensory stimuli and multimodal electrical stimulation rehabilitation. The investigators hope to establish an atresia nerve regulation strategy and observe that the original blocked neural circuits can improve nerve plasticity by SCS. Even can establish new connections through residual nerves and allow SCI patients to rebuild neural circuits without SCS to restore limbs mobility and improve quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epidural Stimulator | Experimental | Device: Epidural StimulatorParticipants will have a 16-electrode epidural array implanted in the C4-C7 and T11-L2 areas of the spinal cord. Following a 2 weeks recovery period, patients will engage in a structured training of physical rehabilitation and electrical stimulation. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- SCI ASIA: A, B, C,D
- Between 20 and 70 year of age
- >1 year post SCI
- Complete or incomplete spinal cord injury.
- Expected will undergo spinal cord stimulation surgery.
Key exclusion criteria (8 listed)
- Have significant cognitive impairment (MMSE<24).
- Had a mental illness within one year or been treated in the past.
- Have Major depressive disorder.
- Active cancer diagnosis.
- Painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore, or urinary tract infection that might interfere with stand or step training.
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 |
|---|---|---|
| Epidural StimulatorParticipants will have a 16-electrode epidural array implanted in the C4-C7 and T11-L2 areas of the spinal cord. Following a 2 weeks recovery period, patients will engage in a structured training of physical rehabilitation and electrical stimulation. | Device | Epidural Stimulator |
Primary outcome
Electroencephalography and Electromyography
Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.
To measure activity in the brain
Electromyographic analysis
Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.
Average of 5-repetitive EMG activity for each superficial component of muscles from a five-second ramp contraction to the end of a ten-second rest
Single transcranial magnetic stimulation
Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.
To evaluate the function of corticospinal tract nerve conduction
Motion Analysis
Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.
To evaluate the angles that can be achieved at each joint of the upper limbs
Functional Test
Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.
To evaluate gait for subjects who can walk by assistive device or independently
9 secondary outcomes
American Spinal Injury Association (ASIA-2019) Impairment Scale
Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.
Modified Ashworth scale
Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.
Barthel Index
Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.
World Health Organization Quality of Life Brief Version
Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.
Spinal Cord Independence Measure
Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.
Box and Block Test
Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.
Action Research Arm Test Scoring Sheet
Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.
Berg Balance Scale
Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.
Walking Index for Spinal Cord Injury II (WISCI II- March 2005)
Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.
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 22 Jul 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.
Sheng-Tzung Tsai, M.D., Ph.D. principal investigator
Hualien Tzu Chi General 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 Epidural Stimulator in people with Spinal Cord Injuries, run by Buddhist Tzu Chi General Hospital 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 8 inclusion and 8 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 22 Jul 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 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?
Contact Sheng-Tzung Tsai, M.D., Ph.D. (+886-3-856-1825 ext. 13054, flydream.tsai@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Electroencephalography and Electromyography (time frame: To measure assessing change between pre-implant and every 3 months until 24 months.). The study lists 5 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 22 Jul 2026.