High-density peripheral nerve cuffs restore natural sensation to
                    individuals with lower-limb amputations

Charkhkar, Hamid; Shell, Courtney E.; Marasco, Paul D.; Pinault, Gilles; Tyler, Dustin J.; Triolo, Ronald J.

doi:10.1088/1741-2552/aac964

Cited by 95 publications

(115 citation statements)

References 57 publications

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“…have been described previously 23 . Both participants had 16-contact Composite Flat Interface Nerve Electrodes (C-FINEs) installed around their sciatic, tibial and/or common peroneal nerves during an outpatient surgical procedure.…”

Section: Neural Interface Technology the Details Of Neural Interfacementioning

confidence: 99%

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Sensory neuroprosthesis improves postural stability during Sensory Organization Test in lower-limb amputees

Charkhkar

Christie

Triolo

2020

Sci Rep

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To maintain postural stability, unilateral lower-limb amputees (LLAs) heavily rely on visual and vestibular inputs, and somatosensory cues from their intact leg to compensate for missing somatosensory information from the amputated limb. When any of these resources are compromised, LLAs exhibit poor balance control compared to able-bodied individuals. We hypothesized that restoring somatosensation related to the missing limb via direct activation of the sensory nerves in the residuum would improve the standing stability of LLAs. We developed a closed-loop sensory neuroprosthesis utilizing non-penetrating multi-contact cuff electrodes implanted around the residual nerves to elicit perceptions of the location and intensity of plantar pressures under the prosthetic feet of two transtibial amputees. Effects of the sensory neuroprosthesis on balance were quantified with the Sensory Organization Test and other posturographic measures of sway. In both participants, the sensory neuroprosthesis improved equilibrium and sway when somatosensation from the intact leg and visual inputs were perturbed simultaneously. One participant also showed improvement with the sensory neuroprosthesis whenever somatosensation in the intact leg was compromised via perturbations of the platform. These observations suggest the sensory feedback elicited by neural stimulation can significantly improve the standing stability of LLAs, particularly when other sensory inputs are depleted or otherwise compromised. Individuals with lower limb amputation face challenges in maintaining their balance when navigating uneven terrains or encountering perturbations during walking 1-3. The fear of falling and decreased balance confidence are prevalent among lower limb amputees (LLAs) 2,4 , which are important factors in their mobility and participation in social activities 4-8. Compared to individuals without lower limb loss, LLAs have slower walking speeds, possibly because of decreased gait stability and the need for increased conscious attention while walking on uneven or changing terrains 1. In a survey of community-dwelling LLAs, more than 50% reported that they had fallen at least once in the past year 4,9. Amputees typically place more trust in the intact limb, which results in overuse and destructive long-term consequences, such as osteoarthritis of the intact knee and/or hip 10. Decreased loading on the affected limb can also lead to osteopenia and subsequent osteoporosis. With the growing number of people who lose limbs due to vascular diseases or trauma, it is important to develop assistive technologies that improve standing stability in this population. Three main sensory systems, the visual, vestibular, and somatosensory, contribute to stable posture during stance 11,12. Theses inputs are integrated and processed in the central nervous system which generates appropriate movement strategies and motor commands to maintain postural stability 13,14. However, when any of the sensory inputs are absent or inaccurate, the CNS adjusts the gains for each ...

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Section: Neural Interface Technology the Details Of Neural Interfacementioning

confidence: 99%

“…experiments described elsewhere 23,31,32 . The Louis Stokes Cleveland Veterans Affairs Medical Center Institutional Review Board and Department of the Navy Human Research Protection Program approved all study procedures, which were conducted under an Investigational Device Exemption obtained from the United States Food and Drug Administration.…”

mentioning

confidence: 99%

Sensory neuroprosthesis improves postural stability during Sensory Organization Test in lower-limb amputees

Charkhkar

Christie

Triolo

2020

Sci Rep

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“…a few trials 15,16 with direct nerve stimulation that did not show clear benefits for the leg amputees have been conducted. Restoring sensory feedback from the phantom hand of upper-limb amputees through neural stimulation has been shown to decrease phantom limb pain (PLP) 13,17,18 .…”

mentioning

confidence: 99%

Sensory feedback restoration in leg amputees improves walking speed, metabolic cost and phantom pain

Petrini

Bumbaširević

Valle

et al. 2019

Nat Med

201

248

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Conventional leg prostheses do not convey sensory information about motion or interaction with the ground to aboveknee amputees, thereby reducing confidence and walking speed in the users that is associated with high mental and physical fatigue 1-4 . The lack of physiological feedback from the remaining extremity to the brain also contributes to the generation of phantom limb pain from the missing leg 5,6 . To determine whether neural sensory feedback restoration addresses these issues, we conducted a study with two transfemoral amputees, implanted with four intraneural stimulation electrodes 7 in the remaining tibial nerve (ClinicalTrials. gov identifier NCT03350061). Participants were evaluated while using a neuroprosthetic device consisting of a prosthetic leg equipped with foot and knee sensors. These sensors drive neural stimulation, which elicits sensations of knee motion and the sole of the foot touching the ground. We found that walking speed and self-reported confidence increased while mental and physical fatigue decreased for both participants during neural sensory feedback compared to the no stimulation trials. Furthermore, participants exhibited reduced phantom limb pain with neural sensory feedback. The results from these proof-of-concept cases provide the rationale for larger population studies investigating the clinical utility of neuroprostheses that restore sensory feedback.Despite advances in the development of lower-limb prosthetics 8 , the potential benefits of restoring sensory feedback from such devices to transfemoral (above-knee) or transtibial (below-knee) amputees has not been investigated. Most surgery techniques 9 and noninvasive methods 10-12 to restore sensory feedback have been tested only in transtibial amputations, which produce a less disabling clinical condition than transfemoral amputation 1,3 . Direct neural stimulation through transversal intrafascicular multichannel electrodes (TIMEs) 7 has enabled upper-limb amputees to feel touch sensations from the missing hand and to exploit them for long-term prosthesis control 13,14 . Only F.M.P. designed the study, developed the software and the overall system integration, performed and supervised the experiments, analyzed the data and wrote and reviewed the paper. M.B. performed the surgeries, was responsible for all the clinical aspects of the study and reviewed the manuscript. G.V. developed the software and the overall system integration, performed the experiments, analyzed the data and reviewed the manuscript. V.I. and S. Mazic collected and analyzed the metabolic measurements. P.M. and B.M. collected and analyzed the EEG measurements. P.C. and T.S. developed the TIME electrodes and delivered technical assistance during the implantation and explanation procedures. F.B. and D.B. developed the software and the overall system integration and performed the experiments. N.K. analyzed the data. D.G. and D.A. designed the hardware and embedded software (real-time control) for STIMEP. K.L. and A.A. participated in the experimental design...

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“…The newer version, the composite flat interface nerve electrode (C-FINE), minimizes the bulk and stiffness of the FINE, because it involves a stiff polymer bar laminated between two layers of flexible silicone sheeting [74]. The C-FINE was found successful in restoring sensation in individuals with a lower limb amputation [75]. The flexible neural clip contains two gold electrodes coated with iridium oxide and it is designed for easy surgical implantation onto small nerves.…”

Section: Extraneural Electrodesmentioning

confidence: 99%

Interfaces with the peripheral nervous system for the control of a neuroprosthetic limb: a review

Yildiz

Shin

Kaufman

2020

J NeuroEngineering Rehabil

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The field of prosthetics has been evolving and advancing over the past decade, as patients with missing extremities are expecting to control their prostheses in as normal a way as possible. Scientists have attempted to satisfy this expectation by designing a connection between the nervous system of the patient and the prosthetic limb, creating the field of neuroprosthetics. In this paper, we broadly review the techniques used to bridge the patient's peripheral nervous system to a prosthetic limb. First, we describe the electrical methods including myoelectric systems, surgical innovations and the role of nerve electrodes. We then describe non-electrical methods used alone or in combination with electrical methods. Design concerns from an engineering point of view are explored, and novel improvements to obtain a more stable interface are described. Finally, a critique of the methods with respect to their long-term impacts is provided. In this review, nerve electrodes are found to be one of the most promising interfaces in the future for intuitive user control. Clinical trials with larger patient populations, and for longer periods of time for certain interfaces, will help to evaluate the clinical application of nerve electrodes.

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High-density peripheral nerve cuffs restore natural sensation to individuals with lower-limb amputations

Cited by 95 publications

References 57 publications

Sensory neuroprosthesis improves postural stability during Sensory Organization Test in lower-limb amputees

Sensory neuroprosthesis improves postural stability during Sensory Organization Test in lower-limb amputees

Sensory feedback restoration in leg amputees improves walking speed, metabolic cost and phantom pain

Interfaces with the peripheral nervous system for the control of a neuroprosthetic limb: a review

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