Spinal Cord Injury(SCI)NCT07722429
Exploration of the Effectiveness and Mechanism of Personalized Epidural Electrical Stimulation in Improving Upper Limb Function in Participants With Spinal Cord Injury
A study testing Epidural electrical stimulation (EES) in people with Spinal Cord Injury(SCI), run by Buddhist Tzu Chi General Hospital at 1 site in Taiwan.
Trial summary
This study aimed to determine whether cervical spinal cord epidural electrical stimulation (EES) can activate upper-limb muscles in individuals with spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injury(SCI)
- What is being tested?
- Epidural electrical stimulation (EES)
- 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
- 17 Nov 2025to 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years.
- Duration since spinal cord injury ranging from 1 to 10 years.
- Spinal cord injury level at or above T4.
- MRI and/or CT imaging confirms adequate spinal cord decompression and spinal stability.
- Stable vital signs and no dependence on mechanical ventilation.
- Stable neurological and psychological status, with no history of neurological deterioration within the past 6 months (e.g., acute worsening of motor or sensory function, new-onset seizures, acute changes in muscle tone, or other neurological symptoms). Participants must be conscious, able to understand, and comply with study instructions. Clinical neurological examinations and imaging findings (MRI or CT) should demonstrate no new abnormalities.
- Willingness to participate in and comply with rehabilitation programs.
- Participants who have completed spinal cord electrical stimulation implantation surgery and/or are currently undergoing conventional rehabilitation therapy.
Who cannot join
- Patients with untreated fractures of the upper extremities.
- Patients with severe skin lesions or wounds that interfere with EMG electrode placement or the surgical sites for electrical stimulation implantation (e.g., chest/back, upper extremities, posterior cervical region, or subclavicular area).
- Patients with a history of other neurological diseases.
- Patients with known allergy or hypersensitivity to silver (Ag).
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
Sheng-Tzung Tsai, M.D., Ph.D, +886-3-856-1825 ext. 13054, flydream.tsai@gmail.com
About this study
This study aimed to determine whether cervical spinal cord epidural electrical stimulation (EES) can activate upper-limb muscles in individuals with spinal cord injury.
Read the detailed description
This study aims to determine whether epidural electrical stimulation (EES) of the cervical spinal cord can activate arm and hand muscles in patients with spinal cord injury. Participants will undergo surgery to implant a system designed for cervical spinal cord EES. Following surgery, they will engage in structured physical rehabilitation and electrical stimulation therapy. Researchers will quantify the motor potentials in arm and hand muscles evoked by cervical EES, adjust stimulation parameters to optimize the elicitation of arm and hand movements, and assess the participants' upper-limb motor function using standard clinical tests and simple motor tasks.
- Conditions
- Spinal Cord Injury(SCI)
- Being tested
- Epidural electrical stimulation (EES)
- 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 electrical stimulation (EES)Device
Subjects will undergo a surgical procedure to implant a system that provides epidural electrical stimulation (EES) of the cervical spinal cord. After surgery, subjects will undergo a structured physical rehabilitation program and electrical stimulation.
| Study group | Role | What they receive |
|---|---|---|
| Epidural electrical stimulation (EES) | Experimental | Participants will undergo implantation of a 16-electrode epidural spinal cord array. Following surgery, they will participate in a structured program of physical rehabilitation combined with epidural electrical stimulation. Receives: Device: Epidural electrical stimulation (EES) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in functional independence as measured by the Spinal Cord Independence Measure III (SCIM-III)
The Spinal Cord Independence Measure III (SCIM-III) is a standardized functional assessment tool specifically designed for individuals with spinal cord injury. It evaluates independence in daily activities, including self-care, respiration and sphincter management, and mobility, to quantify the impact of spinal cord injury on functional ability. The SCIM-III consists of 19 items, Each item is typically scored on a scale ranging from 0 (completely dependent) to 3 (completely independent).with higher scores indicating greater independence in activities of daily living.
Measured: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Change in ASIA Impairment Scale (AIS) grade assessed using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI).
The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) is a standardized assessment of motor and sensory function following spinal cord injury. Neurological impairment is classified using the American Spinal Injury Association (ASIA) Impairment Scale (AIS), which ranges from Grade A (complete injury) to Grade E (normal motor and sensory function). Higher AIS grades indicate better neurological function and less severe neurological impairment.
Measured: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Change dexterity of the upper limb as measured by the Action Research Arm Test (ARAT)
Use the Action Research Arm Test (ARAT) assessment to quantify functional hand and arm dexterity. The score ranges from 0 to 57, with a higher value indicating better function.
Measured: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Change in hand dexterity as measured by the Box and Block Test (BBT).
The Box and Block Test (BBT) assesses manual dexterity and upper extremity function by measuring the number of blocks transferred within 60 seconds. Higher scores indicate better hand function and coordination.
Measured: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Secondary outcomes (3)
Change in spasticity as measured by the Modified Ashworth Scale (MAS)
Quantify spasticity scores using the Modified Ashworth Scale (MAS) for the shoulder, elbow, and wrist. The muscle tension is divided into 0-4 grades. The lower the score, the closer to normal. The higher the score, the more severe the spasticity.
Measured: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Change in activities of daily living as measured by the Barthel Index (BI).
The Barthel Index (BI) assesses functional independence in activities of daily living across 10 domains, including self-care, mobility, and continence. Scores range from 0 to 100, with higher scores indicating greater independence.
Measured: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Change in Quality of Life (QOL) as measured by the World Health Organization Quality of Life (WHOQOL-BREF)
The WHOQOL-BREF is a self-administered questionnaire comprising 26 questions on the individual's perceptions of their health and well-being over the previous two weeks. Responses to questions are on a 1-5 Likert scale where 1 represents "disagree" or "not at all" and 5 represents "completely agree" or "extremely". , The higher the score, the better the quality of life
Measured: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start17 Nov 2025
- Primary completion31 Dec 2027 (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 Injury(SCI)Studies 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
- NCT07722429
- Sponsor's protocol ID
- IRB114-101-A
- Other IDs
- NSTC 114-2314-B-303-011
- Status last verified
- Aug 2025
- First submitted
- 20 Jul 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploration of the Effectiveness and Mechanism of Personalized Epidural Electrical Stimulation in Improving Upper Limb Function in Participants With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT07722429
- Acronym / sponsor ID
- IRB114-101-A
- Conditions
- Spinal Cord Injury(SCI)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Buddhist Tzu Chi General HospitalUniversity, hospital or other
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Jul 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 study aimed to determine whether cervical spinal cord epidural electrical stimulation (EES) can activate upper-limb muscles in individuals with spinal cord injury.
Detailed description
This study aims to determine whether epidural electrical stimulation (EES) of the cervical spinal cord can activate arm and hand muscles in patients with spinal cord injury. Participants will undergo surgery to implant a system designed for cervical spinal cord EES. Following surgery, they will engage in structured physical rehabilitation and electrical stimulation therapy. Researchers will quantify the motor potentials in arm and hand muscles evoked by cervical EES, adjust stimulation parameters to optimize the elicitation of arm and hand movements, and assess the participants' upper-limb motor function using standard clinical tests and simple motor tasks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Epidural electrical stimulation (EES) | Experimental | Device: Epidural electrical stimulation (EES)Participants will undergo implantation of a 16-electrode epidural spinal cord array. Following surgery, they will participate in a structured program of physical rehabilitation combined with epidural electrical stimulation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age between 18 and 70 years.
- Duration since spinal cord injury ranging from 1 to 10 years.
- Spinal cord injury level at or above T4.
- MRI and/or CT imaging confirms adequate spinal cord decompression and spinal stability.
- Stable vital signs and no dependence on mechanical ventilation.
Key exclusion criteria (4 listed)
- Patients with untreated fractures of the upper extremities.
- Patients with severe skin lesions or wounds that interfere with EMG electrode placement or the surgical sites for electrical stimulation implantation (e.g., chest/back, upper extremities, posterior cervical region, or subclavicular area).
- Patients with a history of other neurological diseases.
- Patients with known allergy or hypersensitivity to silver (Ag).
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 electrical stimulation (EES)Subjects will undergo a surgical procedure to implant a system that provides epidural electrical stimulation (EES) of the cervical spinal cord. After surgery, subjects will undergo a structured physical rehabilitation program and electrical stimulation. | Device | Epidural electrical stimulation (EES) |
Primary outcome
Change in functional independence as measured by the Spinal Cord Independence Measure III (SCIM-III)
Time frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
The Spinal Cord Independence Measure III (SCIM-III) is a standardized functional assessment tool specifically designed for individuals with spinal cord injury. It evaluates independence in daily activities, including self-care, respiration and sphincter management, and mobility, to quantify the impact of spinal cord injury on functional ability. The SCIM-III consists of 19 items, Each item is typically scored on a scale ranging from 0 (completely dependent) to 3 (completely independent).with higher scores indicating greater independence in activities of daily living.
Change in ASIA Impairment Scale (AIS) grade assessed using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI).
Time frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) is a standardized assessment of motor and sensory function following spinal cord injury. Neurological impairment is classified using the American Spinal Injury Association (ASIA) Impairment Scale (AIS), which ranges from Grade A (complete injury) to Grade E (normal motor and sensory function). Higher AIS grades indicate better neurological function and less severe neurological impairment.
Change dexterity of the upper limb as measured by the Action Research Arm Test (ARAT)
Time frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Use the Action Research Arm Test (ARAT) assessment to quantify functional hand and arm dexterity. The score ranges from 0 to 57, with a higher value indicating better function.
Change in hand dexterity as measured by the Box and Block Test (BBT).
Time frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
The Box and Block Test (BBT) assesses manual dexterity and upper extremity function by measuring the number of blocks transferred within 60 seconds. Higher scores indicate better hand function and coordination.
3 secondary outcomes
Change in spasticity as measured by the Modified Ashworth Scale (MAS)
Time frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Change in activities of daily living as measured by the Barthel Index (BI).
Time frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Change in Quality of Life (QOL) as measured by the World Health Organization Quality of Life (WHOQOL-BREF)
Time frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation
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 24 Jul 2026.
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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 electrical stimulation (EES) in people with Spinal Cord Injury(SCI), 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 4 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 24 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?
Change in functional independence as measured by the Spinal Cord Independence Measure III (SCIM-III) (time frame: Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation). The study lists 4 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 24 Jul 2026.