An interventional study of Epidural Stimulator in Spinal Cord Injuries, sponsored by Buddhist Tzu Chi General Hospital. Recruiting at 1 site in Taiwan. Open to participants aged 20 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-07-22.
Sponsored by Buddhist Tzu Chi General Hospital · Not applicable, Interventional, and Treatment
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.
2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.
This study's planned enrollment of 20 is below the median of 24 across 1,633 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Buddhist Tzu Chi General Hospital is the lead sponsor of 88 studies on the registry; 20 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Epidural Stimulator
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.
Electroencephalography and Electromyography
To measure activity in the brain
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.
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.
Time frame: 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.
Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.
Barthel Index
To measure performance in activities of daily living
Time frame: 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
Time frame: 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
Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.
Box and Block Test
To measure unilateral gross manual dexterity.
Time frame: 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.
Time frame: 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.
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)
To measure walking ability for spinal cord injury.
Time frame: To measure assessing change between pre-implant and every 3 months until 24 months.
Plan to share: No
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Buddhist Tzu Chi General Hospital