Non-invasive spinal cord electrical stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial.
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State: Public
Version: author
License: CC BY 4.0
Serval ID
serval:BIB_4062FEE24797
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Non-invasive spinal cord electrical stimulation for arm and hand function in chronic tetraplegia: a safety and efficacy trial.
Journal
Nature medicine
ISSN
1546-170X (Electronic)
ISSN-L
1078-8956
Publication state
Published
Issued date
05/2024
Peer-reviewed
Oui
Volume
30
Number
5
Pages
1276-1283
Language
english
Notes
Publication types: Journal Article ; Multicenter Study ; Clinical Trial
Publication Status: ppublish
Publication Status: ppublish
Abstract
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 <sup>EX</sup> Therapy to improve arm and hand functions in people with chronic SCI. ARC <sup>EX</sup> 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 <sup>EX</sup> Therapy compared to the end of an equivalent period of rehabilitation alone. Sixty participants completed the protocol. No serious adverse events related to ARC <sup>EX</sup> 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 <sup>EX</sup> Therapy to improve hand and arm functions in people living with cervical SCI. ClinicalTrials.gov identifier: NCT04697472 .
Keywords
Humans, Quadriplegia/therapy, Quadriplegia/physiopathology, Male, Hand/physiopathology, Female, Middle Aged, Adult, Arm/physiopathology, Spinal Cord Injuries/therapy, Spinal Cord Injuries/physiopathology, Spinal Cord Injuries/rehabilitation, Spinal Cord Stimulation/methods, Treatment Outcome, Quality of Life, Prospective Studies, Chronic Disease, Aged, Electric Stimulation Therapy/methods, Electric Stimulation Therapy/adverse effects
Pubmed
Web of science
Open Access
Yes
Create date
24/05/2024 9:46
Last modification date
09/08/2024 15:52