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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 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural Stimulator | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Electroencephalography and Electromyography | To measure activity in the brain | 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 | 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 | 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 | 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 | To measure assessing change between pre-implant and every 3 months until 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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 | 970 | Taiwan |
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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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| 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. | To measure assessing change between pre-implant and every 3 months until 24 months. |
| Barthel Index | To measure performance in activities of daily living | 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 | 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 | To measure assessing change between pre-implant and every 3 months until 24 months. |
| Box and Block Test | To measure unilateral gross manual dexterity. | 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. | 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. | 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. | To measure assessing change between pre-implant and every 3 months until 24 months. |
| D014947 | Wounds and Injuries |