Spinal Cord Stimulation for Spinal Cord Injury Patients - Regain Walk and Alleviate Pain
NCT ID: NCT05433064
Last Updated: 2025-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
12 participants
INTERVENTIONAL
2020-05-01
2025-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Epidural Stimulator
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.
Epidural Stimulator
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.
Interventions
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Epidural Stimulator
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
20 Years
70 Years
ALL
No
Sponsors
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Buddhist Tzu Chi General Hospital
OTHER
Responsible Party
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Principal Investigators
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Sheng-Tzung Tsai, M.D., Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Hualien Tzu Chi General Hospital
Locations
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Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital
Hualien City, Taiwan, Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
Other Identifiers
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TCMF-EP 110-02(111)
Identifier Type: -
Identifier Source: org_study_id
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