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The study aims to examine the plausible interventional mechanisms underlying the effects of epidural spinal cord stimulation.
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 lower limb activity so that SCI patients can restore the ability to stand and walk 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 lower limb mobility and improve quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural Stimulator | Experimental | Subjects will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord. After 2 weeks recovery,patients will undergo a structured program of physical rehabilitation and electrical stimulation. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural Stimulator | Device | Subjects will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord. After 2 weeks recovery,patients will undergo a structured program of physical rehabilitation and electrical stimulation. |
| Measure | Description | Time Frame |
|---|---|---|
| 6-Meter Time Up and Go (6TUG) | To evaluate gait for subjects who can walk by assistive device or independently. | To measure assessing change between pre-implant and every 3 months until 24 months. |
| Assessment of volitional movement of lower limbs using electromyographic analysis | Average of 6-repetitive EMG activity for each superficial component of muscles from a five-second ramp contraction to the end of a ten-second rest | To measure assessing change between pre-implant and every 3 months until 24 months. |
| Trunk stability measurement (trunk control assessment) | To assess the sitting and walking dynamic balance by displacing the center of pressure (CoP) from the force plate and the trunk accelerations with a tri-axial accelerometer. The experiment includes sitting and walking.pressure (CoP) from the force plate and the trunk accelerations with tri-axial accelerometer. | To measure assessing change between pre-implant and every 3 months until 24 months.] |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sheng-Tzung Tsai, M.D., Ph.D. | Contact | +886-3-856-1825 | 13054 | flydream.tsai@gmail.com |
| Yu-Chen Chen | Contact | +886-3-856-1825 | 13054 | spring810569@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sheng-Tzung Tsai, M.D., Ph.D. | Hualien Tzu Chi General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital | Recruiting | Hualien City | Taiwan | 970 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41134059 | Derived | Wu MY, Chen LH, Yang CH, Wu CC, Huang XL, Yan LC, Lin SZ, Wang PK, Lee CH, Chen YC, Tsai ST. Synergistic effect of epidural electrical stimulation and exoskeleton walk training on dynamic balance for participants with spinal cord injury. J Spinal Cord Med. 2025 Oct 24:1-10. doi: 10.1080/10790268.2025.2574134. Online ahead of print. | |
| 39857740 |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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|
| Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation |
| Change in spasticity as measured by the Modified Ashworth Scale (MAS) | It is mainly used to assess muscle spasm (spasticity). 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. | Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation |
| Change in motor recovery as measured by the Total American Spinal Injury Association (ASIA) motor score | The American Spinal Injury Association (ASIA) Standard Neurological Classification of Spinal Cord Injury is a standard method of assessing the neurological status, including motor and sensory evaluations, of a person who has sustained a spinal cord injury. | Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation |
| Change in ability (or inability) to safely balance as measured by the Berg Balance Scale (BBS) | It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function and takes approximately 20 minutes to complete. It does not include the assessment of gait.a 14-item scale. | Baseline; 7 months after implant |
| Chen YC, Huang XL, Cheng HY, Wu CC, Wu MY, Yan LC, Chen SY, Tsai ST, Lin SZ. Role of Epidural Electrode Stimulation in Three Patients with Incomplete AIS D Spinal Cord Injury. Biomedicines. 2025 Jan 10;13(1):155. doi: 10.3390/biomedicines13010155. |
| D014947 | Wounds and Injuries |