Epidural Electrical Stimulation for Spinal Cord Injury Patients and Corticospinal Motor Circuit Improvement
NCT ID: NCT06455137
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
20 participants
INTERVENTIONAL
2024-04-30
2026-12-31
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
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.
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.
Interventions
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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.
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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB112-067-A
Identifier Type: -
Identifier Source: org_study_id
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