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Non-invasive spinal cord electrical stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial
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Non-invasive spinal cord electrical stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial
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Journal Article
Non-invasive spinal cord electrical stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial
2024
Overview
Cervical spinal cord injury (SCI) leads to permanent impairment of arm and hand functions. Here we conducted a prospective, single-arm, multicenter, open-label, non-significant risk trial that evaluated the safety and efficacy of ARC
EX
Therapy to improve arm and hand functions in people with chronic SCI. ARC
EX
Therapy involves the delivery of externally applied electrical stimulation over the cervical spinal cord during structured rehabilitation. The primary endpoints were safety and efficacy as measured by whether the majority of participants exhibited significant improvement in both strength and functional performance in response to ARC
EX
Therapy compared to the end of an equivalent period of rehabilitation alone. Sixty participants completed the protocol. No serious adverse events related to ARC
EX
Therapy were reported, and the primary effectiveness endpoint was met. Seventy-two percent of participants demonstrated improvements greater than the minimally important difference criteria for both strength and functional domains. Secondary endpoint analysis revealed significant improvements in fingertip pinch force, hand prehension and strength, upper extremity motor and sensory abilities and self-reported increases in quality of life. These results demonstrate the safety and efficacy of ARC
EX
Therapy to improve hand and arm functions in people living with cervical SCI. ClinicalTrials.gov identifier:
NCT04697472
.
Externally applied electrical stimulation over the cervical spinal cord improves arm and hand functions in people with chronic tetraplegia due to spinal cord injury.
Publisher
Nature Publishing Group US,Nature Publishing Group
Subject
/ Adult
/ Aged
/ Arm
/ Biomedical and Life Sciences
/ Electric Stimulation Therapy - adverse effects
/ Electric Stimulation Therapy - methods
/ Female
/ Grasping
/ Hand
/ Humans
/ Male
/ Quadriplegia - physiopathology
/ Safety
/ Spinal Cord Injuries - physiopathology
/ Spinal Cord Injuries - rehabilitation
/ Spinal Cord Injuries - therapy
/ Spinal Cord Stimulation - methods
/ Therapy
