NCT07722429|RecruitingFDA Device
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · National Science and Technology Council, R.O.C
interventional
20
1 country
1
Study Start
November 17, 2025
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study aimed to determine whether cervical spinal cord epidural electrical stimulation (EES) can activate upper-limb muscles in individuals with spinal cord injury.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 17, 2025
Actual (reported)July 20, 2026
Actual (reported)July 23, 2026
Actual (reported)December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in functional independence as measured by the Spinal Cord Independence Measure III (SCIM-III)
The Spinal Cord Independence Measure III (SCIM-III) is a standardized functional assessment tool specifically designed for individuals with spinal cord injury. It evaluates independence in daily activities, including self-care, respiration and sphincter management, and mobility, to quantify the impact of spinal cord injury on functional ability. The SCIM-III consists of 19 items, Each item is typically scored on a scale ranging from 0 (completely dependent) to 3 (completely independent).with higher scores indicating greater independence in activities of daily living.
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Change in ASIA Impairment Scale (AIS) grade assessed using the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI).
The International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) is a standardized assessment of motor and sensory function following spinal cord injury. Neurological impairment is classified using the American Spinal Injury Association (ASIA) Impairment Scale (AIS), which ranges from Grade A (complete injury) to Grade E (normal motor and sensory function). Higher AIS grades indicate better neurological function and less severe neurological impairment.
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Change dexterity of the upper limb as measured by the Action Research Arm Test (ARAT)
Use the Action Research Arm Test (ARAT) assessment to quantify functional hand and arm dexterity. The score ranges from 0 to 57, with a higher value indicating better function.
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Change in hand dexterity as measured by the Box and Block Test (BBT).
The Box and Block Test (BBT) assesses manual dexterity and upper extremity function by measuring the number of blocks transferred within 60 seconds. Higher scores indicate better hand function and coordination.
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Change in spasticity as measured by the Modified Ashworth Scale (MAS)
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Change in activities of daily living as measured by the Barthel Index (BI).
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after the implantation
Change in Quality of Life (QOL) as measured by the World Health Organization Quality of Life (WHOQOL-BREF)
Baseline; at 1 - 4 - 7 - 13 - 19 - 25 months after implantation
Participants will undergo implantation of a 16-electrode epidural spinal cord array. Following surgery, they will participate in a structured program of physical rehabilitation combined with epidural electrical stimulation.
Subjects will undergo a surgical procedure to implant a system that provides epidural electrical stimulation (EES) of the cervical spinal cord. After surgery, subjects will undergo a structured physical rehabilitation program and electrical stimulation.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Buddhist Tzu Chi Medical Foundation Hualien Tzu Chi Hospital
Hualien City, Taiwan
Sheng-Tzung Tsai, M.D., Ph.D
Hualien Tzu Chi General Hospital
First Submitted
July 20, 2026
First Posted
July 23, 2026
Study Start
November 17, 2025
Actual (reported)Primary Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Study Completion
December 31, 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 24, 2026
Record last verified: 2025-08
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Source: ClinicalTrials.gov.
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