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1. Bringing sensation to prosthetic hands—chronic assessment of implanted thin-film electrodes in humans

Author

Paul Čvančara, Giacomo Valle, Matthias Müller, Inga Bartels, Thomas Guiho, Arthur Hiairrassary, Francesco Petrini, Stanisa Raspopovic, Ivo Strauss, Giuseppe Granata, Eduardo Fernandez, Paolo M. Rossini, Massimo Barbaro, Ken Yoshida, Winnie Jensen, Jean-Louis Divoux, David Guiraud, Silvestro Micera, and Thomas Stieglitz

Subjects
Electronics, TK7800-8360, Materials of engineering and construction. Mechanics of materials, TA401-492
Abstract

Abstract Direct stimulation of peripheral nerves with implantable electrodes successfully provided sensory feedback to amputees while using hand prostheses. Longevity of the electrodes is key to success, which we have improved for the polyimide-based transverse intrafascicular multichannel electrode (TIME). The TIMEs were implanted in the median and ulnar nerves of three trans-radial amputees for up to six months. We present a comprehensive assessment of the electrical properties of the thin-film metallization as well as material status post explantationem. The TIMEs stayed within the electrochemical safe limits while enabling consistent and precise amplitude modulation. This lead to a reliable performance in terms of eliciting sensation. No signs of corrosion or morphological change to the thin-film metallization of the probes was observed by means of electrochemical and optical analysis. The presented longevity demonstrates that thin-film electrodes are applicable in permanent implant systems.

Published
2023
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2. Author Correction: Bringing sensation to prosthetic hands—chronic assessment of implanted thin-film electrodes in humans

Author

Paul Čvančara, Giacomo Valle, Matthias Müller, Inga Bartels, Thomas Guiho, Arthur Hiairrassary, Francesco Petrini, Stanisa Raspopovic, Ivo Strauss, Giuseppe Granata, Eduardo Fernandez, Paolo M. Rossini, Massimo Barbaro, Ken Yoshida, Winnie Jensen, Jean-Louis Divoux, David Guiraud, Silvestro Micera, and Thomas Stieglitz

Subjects
Electronics, TK7800-8360, Materials of engineering and construction. Mechanics of materials, TA401-492
Published
2024
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3. Selective neural electrical stimulation restores hand and forearm movements in individuals with complete tetraplegia

Author

Wafa Tigra, Mélissa Dali, Lucie William, Charles Fattal, Anthony Gélis, Jean-Louis Divoux, Bertrand Coulet, Jacques Teissier, David Guiraud, and Christine Azevedo Coste

Subjects
Neural stimulation, Tetraplegia, Grasping movement, Multicontact cuff electrode, Selective stimulation, Neurosciences. Biological psychiatry. Neuropsychiatry, RC321-571
Abstract

Abstract Background We hypothesized that a selective neural electrical stimulation of radial and median nerves enables the activation of functional movements in the paralyzed hand of individuals with tetraplegia. Compared to previous approaches for which up to 12 muscles were targeted through individual muscular stimulations, we focused on minimizing the number of implanted electrodes however providing almost all the needed and useful hand movements for subjects with complete tetraplegia. Methods We performed acute experiments during scheduled surgeries of the upper limb with eligible subjects. We scanned a set of multicontact neural stimulation cuff electrode configurations, pre-computed through modeling simulations. We reported the obtained isolated and functional movements that were considered useful for the subject (different grasping movements). Results In eight subjects, we demonstrated that selective stimulation based on multicontact cuff electrodes and optimized current spreading over the active contacts provided isolated, compound, functional and strong movements; most importantly 3 out of 4 had isolated fingers or thumb flexion, one patient performed a Key Grip, another one the Power and Hook Grips, and the 2 last all the 3 Grips. Several configurations were needed to target different areas within the nerve to obtain all the envisioned movements. We further confirmed that the upper limb nerves have muscle specific fascicles, which makes it possible to activate isolated movements. Conclusions The future goal is to provide patients with functional restoration of object grasping and releasing with a minimally invasive solution: only two cuff electrodes above the elbow. Ethics Committee / ANSM clearance prior to the beginning of the study (inclusion period 2016–2018): CPP Sud Méditerranée, #ID-RCB:2014-A01752–45, first acceptance 10th of February 2015, amended 12th of January 2016. Trial registration ( www.clinicaltrials.gov ): # NCT03721861 , Retrospectively registered on 26th of October 2018.

Published
2020
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4. Chronic abdominal vagus stimulation increased brain metabolic connectivity, reduced striatal dopamine transporter and increased mid-brain serotonin transporter in obese miniature pigs

Author

Charles-Henri Malbert, Mickael Genissel, Jean-Louis Divoux, and Christine Henry

Subjects
Vagal stimulation, Bariatric surgery, SERT, DAT, Connectivity analysis, PET imaging, Medicine
Abstract

Abstract Background/objective Changes in brain metabolism has been investigated thoroughly during unilateral cervical chronic vagal stimulation in epileptic or depressive patients. Bilateral stimulation of the abdominal vagus (aVNS) has received less attention despite the reduction in body weight and an altered feeding behavior in obese animals that could be clinically relevant in obese individuals. Our study aims to examine the changes in brain glucose metabolism (CMRglu) induced by aVNS in obese adult miniature pigs. Dopamine (DAT) and serotonin transporters (SERT) were also quantified to further understand the molecular origins of the alterations in brain metabolism. Subjects/methods Pairs of stimulating electrodes were implanted during laparoscopy on both abdominal vagal trunks in 20 obese adult’s miniature pigs. Half of the animals were permanently stimulated while the remaining were sham stimulated. Two months after the onset of stimulation, dynamic 18FDG PET and 123I-ioflupane SPECT were performed. Food intake, resting energy expenditure and fat deposition were also assessed longitudinally. Results Food intake was halved and resting energy expenditure was increased by 60% in aVNS group compared to sham. The gain in body weight was also 38% less in aVNS group compared to sham. Brain metabolic connectivity increased between numerous structures including striatum, mid-brain, amygdala and hippocampus. On the contrary, increased CMRglu were restricted to the thalamus, the periaqueducal grey and the amygdala. DAT binding potential was decreased by about one third in the striatum while SERT was about doubled in the midbrain. Conclusions Our findings demonstrated that aVNS reduced weight gain as a consequence of diminished daily food intake and increased resting energy expenditure. These changes were associated with enhanced connectivity between several brain areas. A lower striatal DAT together with a doubled mid-brain SERT were likely causative for these changes.

Published
2019
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5. The Biomedical Engineer's Pledge 1.0

Author

Antoni Ivorra, Txetxu Ausín, Laura Becerra-Fajardo, Antonio J. del Ama, Jesús Minguillón, Aracelys García-Moreno, Jordi Aguiló, Filipe Oliveira Barroso, Bart Bijnens, Oscar Camara, Sara Capdevila, Roger Castellanos Fernandez, Rafael V. Davalos, Jean-Louis Divoux, Ahmed Eladly, Dario Farina, Carla García Hombravella, Raquel González López, Cesar A Gonzalez, Jordi Grífols, Felipe Maglietti, Shahid Malik, Elad Maor, Guillermo Marshall, Berta Mateu Yus, Lluis M. Mir, Juan C. Moreno, Xavier Navarro, Núria Noguera, Andrés Ozaita, Gemma Piella, José L. Pons, Rita Quesada, Pilar Rivera-Gil, Boris Rubinsky, Aurelio Ruiz Garcia, Albert Ruiz-Vargas, Maria Sánchez Sánchez, Andreas Schneider-Ickert, Ting Shu, Rosa Villa Sanz, Bing Zhang, and Gema Revuelta

Abstract

The professional practice of biomedical engineering can lead to severe consequences. These potential consequences do not differ from those expected in the exercise of the medical profession. Hence, the ethical framework of biomedical engineers (BMEs) should not differ substantially from the ethical framework of medical doctors (MDs). In medicine, an element that is perceived as symbolic but essential in the formation of the ethical conscience of MDs is the “Hippocratic Oath”. The “Hippocratic Oath”, or its modern adaptation, the “Physician's Pledge”, is a brief not legally binding solemn declaration of ethical commitments that medical students take as a rite of passage in their final year or just after graduation. In other healthcare professions, such as nursing or pharmacy, sometimes the “Hippocratic Oath” is also taken. However, in its different versions, the “Hippocratic Oath” contains aspects that would not apply to the field of biomedical engineering and, therefore, its adoption without adaptations would be inappropriate. We have drafted a “Biomedical Engineer’s Pledge” aiming at strengthening the ethical awareness of future biomedical engineers. It consists of a preamble sentence, ten promises, and a concluding sentence. Top priority is given to the first promise, which combines the fundamental principles of beneficence and non-maleficence.

Published
2023
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6. Stability of flexible thin-film metallization stimulation electrodes: analysis of explants after first-in-human study and improvement of in vivo performance

Author

Pawel Maciejasz, David Andreu, Ken Yoshida, Xavier Navarro, Silvestro Micera, Stanisa Raspopovic, Paul Čvančara, Tim Boretius, Victor Lopezalvarez, Eduardo Fernandez, Giuseppe Granata, Thomas Stieglitz, Paolo Maria Rossini, David Guiraud, Jean-Louis Divoux, Winnie Jensen, Francesco Maria Petrini, Bernstein Center Freiburg (BCF), Albert-Ludwigs-Universität Freiburg, Department of Microsystems Engineering [Freiburg] (IMTEK), University of Freiburg [Freiburg], Universitat Autònoma de Barcelona (UAB), Otto Bock Healthcare GmbH, Contrôle Artificiel de Mouvements et de Neuroprothèses Intuitives (CAMIN), Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria), Eidgenössische Technische Hochschule - Swiss Federal Institute of Technology [Zürich] (ETH Zürich), Fondation Bertarelli Chair inTranslational Neuroscience and Neuroengineering [Lausanne], Ecole Polytechnique Fédérale de Lausanne (EPFL)-Fondation Bertarelli, Scuela Santa Anna (SSSA), Scuola Universitaria Superiore Sant'Anna [Pisa] (SSSUP), Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Università cattolica del Sacro Cuore [Piacenza e Cremona] (Unicatt), Perdue University, Center for Sensory-Motor Interaction (SMI), Aalborg University [Denmark] (AAU), AXONIC - OBELIA dept, MXM-Laboratoires de Techologies Médicales, Center for Neuroprosthetics and Institute of Bioengineering, EPFL.-Fondation Bertarelli, and Fondazione 'Policlinico Universitario A. Gemelli' [Rome]

Subjects
Thin-film, Materials science, Electrode, [SDV.NEU.NB]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Neurobiology, 0206 medical engineering, Biomedical Engineering, 02 engineering and technology, polyimide, [SPI.AUTO]Engineering Sciences [physics]/Automatic, 03 medical and health sciences, Cellular and Molecular Neuroscience, chemistry.chemical_compound, 0302 clinical medicine, Amputees, Electric Impedance, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Silicon carbide, Animals, Humans, neural interfaces, Thin film, Electrodes, Delamination, electrode, stability, thin-film, Prostheses and Implants, 020601 biomedical engineering, Electric Stimulation, Electrodes, Implanted, Microelectrode, chemistry, Implant, Neural interfaces, Polyimide, Stability, Microelectrodes, Failure mode and effects analysis, Layer (electronics), 030217 neurology & neurosurgery, Biomedical engineering
Abstract

Objective Micro-fabricated neural interfaces based on polyimide (PI) are achieving increasing importance in translational research. The ability to produce well-defined micro-structures with properties that include chemical inertness, mechanical flexibility and low water uptake are key advantages for these devices. Approach This paper reports the development of the transverse intrafascicular multichannel electrode (TIME) used to deliver intraneural sensory feedback to an upper-limb amputee in combination with a sensorized hand prosthesis. A failure mode analysis on the explanted devices was performed after a first-in-human study limited to 30 d. Main results About 90% of the stimulation contact sites of the TIMEs maintained electrical functionality and stability during the full implant period. However, optical analysis post-explantation revealed that 62.5% of the stimulation contacts showed signs of delamination at the metallization-PI interface. Such damage likely occurred due to handling during explantation and subsequent analysis, since a significant change in impedance was not observed in vivo. Nevertheless, whereas device integrity is mandatory for long-term functionality in chronic implantation, measures to increase the bonding strength of the metallization-PI interface deserve further investigation. We report here that silicon carbide (SiC) is an effective adhesion-promoting layer resisting heavy electrical stimulation conditions within a rodent animal trial. Optical analysis of the new electrodes revealed that the metallization remained unaltered after delivering over 14 million pulses in vivo without signs of delamination at the metallization-PI interface. Significance Failure mode analysis guided implant stability optimization. Reliable adhesion of thin-film metallization to substrate has been proven using SiC, improving the potential transfer of micro-fabricated neural electrodes for chronic clinical applications., Journal of Neural Engineering, 17 (4), ISSN:1741-2560, ISSN:1741-2552

Published
2020

8. Enhancing functional abilities and cognitive integration of the lower limb prosthesis

Author

Marko Bumbasirevic, Bogdan Mijovic, Asgeir Alexandersson, Pavle Mijović, Arthur Hiairrassary, Giacomo Valle, Dario Bortolotti, Atli Örn Sverrisson, Alessandra Pedrocchi, Paul Čvančara, David Guiraud, Aleksandar Lesic, Thomas Stieglitz, Francesco Maria Petrini, Jean-Louis Divoux, Stanisa Raspopovic, Igor Popovic, Federica Barberi, Silvestro Micera, Knut Lechler, Center for Neuroprosthetics [Geneva] (CNP), Ecole Polytechnique Fédérale de Lausanne (EPFL), Fondation Bertarelli Chair inTranslational Neuroscience and Neuroengineering [Lausanne], Center for Neuroprosthetics and Institute of Bioengineering, EPFL.-Fondation Bertarelli, The BioRobotics Institute, Scuola Universitaria Superiore Sant'Anna [Pisa] (SSSUP), Department of Electronics, Information, and Bioengineering [Milano] (DEIB), Politecnico di Milano [Milan] (POLIMI), School of Medecine [Belgrade], University of Belgrade [Belgrade], University of Freiburg [Freiburg], Control of Artificial Movement and Intuitive Neuroprosthesis (CAMIN), Laboratoire d'Informatique de Robotique et de Microélectronique de Montpellier (LIRMM), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria), mBrainTrain [Belgrade], Össur hf [Copenhagen], AXONIC - OBELIA dept, MXM-Laboratoires de Techologies Médicales, Special Hospital for Rehabilitation and Orthopaedic Prosthetics [Belgrade], Department of Microsystems Engineering [Freiburg] (IMTEK), Department of Health Sciences and Technology [ETH Zürich] (D-HEST), Eidgenössische Technische Hochschule - Swiss Federal Institute of Technology [Zürich] (ETH Zürich), Ecole Polytechnique Fédérale de Lausanne (EPFL)-Fondation Bertarelli, and Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Inria Sophia Antipolis - Méditerranée (CRISAM)

Subjects
0301 basic medicine, leg, medicine.medical_specialty, sensory feedback, Neuroprosthetics, Knee Joint, medicine.medical_treatment, media_common.quotation_subject, [SDV.NEU.NB]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Neurobiology, Sensory system, Artificial Limbs, system, Prosthesis Design, neuroprostheses, Prosthesis, [SPI.AUTO]Engineering Sciences [physics]/Automatic, 03 medical and health sciences, walking, 0302 clinical medicine, Physical medicine and rehabilitation, Cognition, Amputees, discharge, Perception, amputation, Activities of Daily Living, medicine, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Humans, knee-joint, media_common, Haptic technology, gait symmetry, Proprioception, Work (physics), General Medicine, 3. Good health, body regions, 030104 developmental biology, Lower Extremity, Psychology, 030217 neurology & neurosurgery, performance
Abstract

International audience; Lower limb amputation (LLA) destroys the sensory communication between the brain and the external world during standing and walking. Current prostheses do not restore sensory feedback to amputees, who, relying on very limited haptic information from the stump-socket interaction, are forced to deal with serious issues: the risk of falls, decreased mobility, prosthesis being perceived as an external object (low embodiment), and increased cognitive burden. Poor mobility is one of the causes of eventual device abandonment. Restoring sensory feedback from the missing leg of above-knee (transfemoral) amputees and integrating the sensory feedback into the sensorimotor loop would markedly improve the life of patients. In this study, we developed a leg neuroprosthesis, which provided real-time tactile and emulated proprioceptive feedback to three transfemoral amputees through nerve stimulation. The feedback was exploited in active tasks, which proved that our approach promoted improved mobility, fall prevention, and agility. We also showed increased embodiment of the lower limb prosthesis (LLP), through phantom leg displacement perception and questionnaires, and ease of the cognitive effort during a dual-task paradigm, through electroencephalographic recordings. Our results demonstrate that induced sensory feedback can be integrated at supraspinal levels to restore functional abilities of the missing leg. This work paves the way for further investigations about how the brain interprets different artificial feedback strategies and for the development of fully implantable sensory-enhanced leg neuroprostheses, which could drastically ameliorate life quality in people with disability.

Published
2019

9. Chronic abdominal vagus stimulation increased brain metabolic connectivity, reduced striatal dopamine transporter and increased mid‑brain serotonin transporter in obese miniature pigs

Author

Christine Henry, Charles-Henri Malbert, Mickael Genissel, Jean-Louis Divoux, US 1395 ANI-SCAN [INRA], Institut National de la Recherche Agronomique (INRA), Unité expérimentale de testage de porcs, Axonic, Sorin Groupe, and Unité Expérimentale de Testage de Porcs

Subjects
0301 basic medicine, obesity, modèle animal, Swine, [SDV]Life Sciences [q-bio], PET imaging, Hippocampus, lcsh:Medicine, Stimulation, Striatum, Weight Gain, 0302 clinical medicine, Mesencephalon, Serotonin transporter, 2. Zero hunger, Serotonin Plasma Membrane Transport Proteins, SPECT imaging, biology, General Medicine, chirurgie bariatrique, animal models, Vagal stimulation, obésité, 030220 oncology & carcinogenesis, Swine, Miniature, medicine.symptom, Connectivity analysis, medicine.drug, Bariatric surgery, SERT, DAT, Animal model, medicine.medical_specialty, Vagus Nerve Stimulation, General Biochemistry, Genetics and Molecular Biology, 03 medical and health sciences, nerf vague, Dopamine, Fluorodeoxyglucose F18, Internal medicine, medicine, vagus nerve, Animals, Resting energy expenditure, miniporc, Dopamine Plasma Membrane Transport Proteins, business.industry, Research, lcsh:R, Neostriatum, 030104 developmental biology, Endocrinology, Glucose, nervous system, tomographie a émission monophotonique, Positron-Emission Tomography, biology.protein, Serotonin, business, Weight gain
Abstract

Background/objective Changes in brain metabolism has been investigated thoroughly during unilateral cervical chronic vagal stimulation in epileptic or depressive patients. Bilateral stimulation of the abdominal vagus (aVNS) has received less attention despite the reduction in body weight and an altered feeding behavior in obese animals that could be clinically relevant in obese individuals. Our study aims to examine the changes in brain glucose metabolism (CMRglu) induced by aVNS in obese adult miniature pigs. Dopamine (DAT) and serotonin transporters (SERT) were also quantified to further understand the molecular origins of the alterations in brain metabolism. Subjects/methods Pairs of stimulating electrodes were implanted during laparoscopy on both abdominal vagal trunks in 20 obese adult’s miniature pigs. Half of the animals were permanently stimulated while the remaining were sham stimulated. Two months after the onset of stimulation, dynamic 18FDG PET and 123I-ioflupane SPECT were performed. Food intake, resting energy expenditure and fat deposition were also assessed longitudinally. Results Food intake was halved and resting energy expenditure was increased by 60% in aVNS group compared to sham. The gain in body weight was also 38% less in aVNS group compared to sham. Brain metabolic connectivity increased between numerous structures including striatum, mid-brain, amygdala and hippocampus. On the contrary, increased CMRglu were restricted to the thalamus, the periaqueducal grey and the amygdala. DAT binding potential was decreased by about one third in the striatum while SERT was about doubled in the midbrain. Conclusions Our findings demonstrated that aVNS reduced weight gain as a consequence of diminished daily food intake and increased resting energy expenditure. These changes were associated with enhanced connectivity between several brain areas. A lower striatal DAT together with a doubled mid-brain SERT were likely causative for these changes. Electronic supplementary material The online version of this article (10.1186/s12967-019-1831-5) contains supplementary material, which is available to authorized users.

Published
2019

10. Phantom somatosensory evoked potentials following selective intraneural electrical stimulation in two amputees

Author

Thomas Stieglitz, Riccardo Di Iorio, Paolo Maria Rossini, Jean-Louis Divoux, Ivo Strauss, Silvestro Micera, Stanisa Raspopovic, David Andreu, Francesco Iodice, Arthur Hiairrassary, Winnie Jensen, Giacomo Valle, Francesco Maria Petrini, David Guiraud, Roberto Romanello, Paul Čvančara, Loic Wauters, Giuseppe Granata, Università cattolica del Sacro Cuore = Catholic University of the Sacred Heart [Roma] (Unicatt), Center for Neuroprosthetics [Geneva] (CNP), Ecole Polytechnique Fédérale de Lausanne (EPFL), Scuola Universitaria Superiore Sant'Anna [Pisa] (SSSUP), Department of Microsystems Engineering [Freiburg] (IMTEK), University of Freiburg [Freiburg], Control of Artificial Movement and Intuitive Neuroprosthesis (CAMIN), Laboratoire d'Informatique de Robotique et de Microélectronique de Montpellier (LIRMM), Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria), MXM-AXONIC, Center for Sensory-Motor Interaction (SMI), Aalborg University [Denmark] (AAU), Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS San Raffaele Pisana), European Project: 602547,EC:FP7:HEALTH,FP7-HEALTH-2013-INNOVATION-1,EPIONE(2013), Università cattolica del Sacro Cuore [Roma] (Unicatt), and Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Inria Sophia Antipolis - Méditerranée (CRISAM)

Subjects
Adult, Male, 0301 basic medicine, Nerve stimulation, Phantom hand, Electrical stimulator, [SDV.NEU.NB]Life Sciences [q-bio]/Neurons and Cognition [q-bio.NC]/Neurobiology, Stimulation, Somatosensory system, Amputation, Surgical, Imaging phantom, [SPI.AUTO]Engineering Sciences [physics]/Automatic, 03 medical and health sciences, 0302 clinical medicine, Amputees, Evoked Potentials, Somatosensory, Physiology (medical), Sensation, [SDV.MHEP.PHY]Life Sciences [q-bio]/Human health and pathology/Tissues and Organs [q-bio.TO], Humans, Medicine, Somatosensory evoked potentials, Brain–computer interface, business.industry, Somatosensory Cortex, Middle Aged, Hand, Electric Stimulation, Sensory Systems, Somatosensory feedback, Robotic hand prosthesis, Settore MED/26 - NEUROLOGIA, 030104 developmental biology, Phantom Limb, Neurology, Somatosensory evoked potential, Neural interface, Neurology (clinical), Female, business, 030217 neurology & neurosurgery, Biomedical engineering
Abstract

International audience; ObjectiveThe aim of the paper is to objectively demonstrate that amputees implanted with intraneural interfaces are truly able to feel a sensation in the phantom hand by recording “phantom” somatosensory evoked potentials from the corresponding brain areas.MethodsWe implanted four transverse intrafascicular multichannel electrodes, available with percutaneous connections to a multichannel electrical stimulator, in the median and ulnar nerves of two left trans-radial amputees. Two channels of the implants that were able to elicit sensations during intraneural nerve stimulation were chosen, in both patients, for recording somatosensory evoked potentials.ResultsWe recorded reproducible evoked responses by stimulating the median and the ulnar nerves in both cases. Latencies were in accordance with the arrival of somatosensory information to the primary somatosensory cortex.ConclusionOur results provide evidence that sensations generated by intraneural stimulation are truly perceived by amputees and located in the phantom hand. Moreover, our results strongly suggest that sensations perceived in different parts of the phantom hand result in different evoked responses.SignificanceSomatosensory evoked potentials obtained by selective intraneural electrical stimulation in amputee patients are a useful tool to provide an objective demonstration of somatosensory feedback in new generation bidirectional prostheses.

Published
2018

11. Effects of chronic abdominal vagal stimulation of small-diameter neurons on brain metabolism and food intake

Author

Chloé Picq, David Guiraud, Eric Bobillier, Charles-Henri Malbert, Jean-Louis Divoux, Christine Henry, US 1395 ANI-SCAN [INRA], Institut National de la Recherche Agronomique (INRA), MXM-AXONIC, Control of Artificial Movement and Intuitive Neuroprosthesis (CAMIN), Laboratoire d'Informatique de Robotique et de Microélectronique de Montpellier (LIRMM), Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria), LivaNova France SAS, Projet PSPC INTENSE, and Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Inria Sophia Antipolis - Méditerranée (CRISAM)

Subjects
Male, medicine.medical_specialty, Food intake, Vagal stimulation, Vagus Nerve Stimulation, Swine, Biophysics, PET imaging, 030209 endocrinology & metabolism, Stimulation, lcsh:RC321-571, [SPI.AUTO]Engineering Sciences [physics]/Automatic, 03 medical and health sciences, Eating, 0302 clinical medicine, Internal medicine, Medicine, Ingestion, Animals, Animal model, Evoked Potentials, lcsh:Neurosciences. Biological psychiatry. Neuropsychiatry, 2. Zero hunger, Neurons, Bariatric surgery, business.industry, General Neuroscience, digestive, oral, and skin physiology, Vagus Nerve, Metabolism, Pet imaging, [SDV.MHEP.EM]Life Sciences [q-bio]/Human health and pathology/Endocrinology and metabolism, pulson, Vagus nerve, Endocrinology, Anesthesia, Positron-Emission Tomography, Female, Neurology (clinical), Brainstem, business, 030217 neurology & neurosurgery, Brain Stem
Abstract

Supplementary data related to this article can be found at http://dx.doi.org/10.1016/j.brs.2017.04.126; International audience; Background :Abdominal bilateral vagal stimulation reduces food intake in animals. However, the classical square wave, mA range current generator is poorly effective to evoke action potentials on A∂ and C neurons that represent the majority of vagal neurons at the abdominal level.Objective/Hypothesis :(i) To ascertain the capability of very high-frequency stimulation schemes (pulsons) to trigger action potentials in abdominal vagal neurons in anaesthetized pigs. (ii) To compare these stimulation schemes with classical ones using PET imaging of brain metabolism and food intake behaviour in conscious pigs.Methods :The current thresholds for pulsons (S2 & S3) and millisecond pulses (S1) required to trigger action potentials were calculated in 5 anaesthetized pigs using single fibre recording. Similar stimulation protocols were compared chronically to sham stimulation in 24 pigs. After two weeks of chronic stimulation, food intake and brain metabolism were investigated. The electrical characteristics and histology of the vagus nerve were also studied.Results :S3 stimulation required a lower amount of charges to trigger an action potential. Chronically applied S2 & S3 activated the dorsal vagal complex and increased the metabolism of its afferent cortical structures. They also reduced energy intake together with a reduced ingestion of high fat and high sugar diets. All these effects were not observed for the S1 group. The vagal histology for the S1, S2 and S3 groups was not different from that of the sham.Conclusions :These findings demonstrate that pulsons applied bilaterally on the abdominal vagus reduced food intake as a consequence of the activation of the brainstem and higher-order brain areas.

Published
2017

12. Obesity-associated alterations in glucose metabolism are reversed by chronic bilateral stimulation of the abdominal vagus nerve

Author

Michael Horowitz, Charles-Henri Malbert, Christine Henry, Jean-Louis Divoux, Chloé Picq, US 1395 ANI-SCAN [INRA], Institut National de la Recherche Agronomique (INRA), Axonic, LivaNova France SAS, Discipline of medicine, University of Adelaide, and Adelaide Royal Hospital (ARH)

Subjects
Blood Glucose, obesity, Swine, Endocrinology, Diabetes and Metabolism, Glucose uptake, medicine.medical_treatment, imagerie cerebrale, Stimulation, human health, 0302 clinical medicine, Abdomen, General Neuroscience, Brain, santé humaine, Glucose clamp technique, 3. Good health, Peripheral, obésité, Liver, Swine, Miniature, Vagus nerve stimulation, medicine.medical_specialty, insulin, diabète de type 2, Vagus Nerve Stimulation, Biophysics, 030209 endocrinology & metabolism, Carbohydrate metabolism, lcsh:RC321-571, 03 medical and health sciences, Insulin resistance, nerf vague, Internal medicine, Internal Medicine, medicine, vagus nerve, Animals, métabolisme du glucose, Muscle, Skeletal, lcsh:Neurosciences. Biological psychiatry. Neuropsychiatry, insuline, miniporc, business.industry, Insulin, Body Weight, medicine.disease, maladie métabolique, Obesity, type ii diabetes, Vagus nerve, Clamp, Endocrinology, Glucose, Positron-Emission Tomography, Glucose Clamp Technique, Neurology (clinical), Insulin Resistance, business, Energy Metabolism, [SDV.AEN]Life Sciences [q-bio]/Food and Nutrition, 030217 neurology & neurosurgery, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

This article contains Supplementary Data online at http://diabetes.diabetesjournals.org/lookup/suppl/doi:10.2337/db16-0847/-/DC1.; Acute vagal stimulation modifies glucose and insulin metabolism, but the effect of chronic bilateral vagal stimulation is not known. Our aim was to quantify the changes in whole body and organ-specific insulin sensitivities, 12 weeks after permanent, bilateral, vagal stimulation performed at the abdominal level in adult mini-pigs. In 15 adult mini-pigs, stimulating electrodes were placed around the dorsal and ventral vagi using laparoscopy and connected to a dual channel stimulator placed subcutaneously. Animals were divided into three groups based on stimulation and body weight i.e. lean non-stimulated, obese non-stimulated and obese-stimulated. Twelve weeks after surgery, glucose uptake and insulin sensitivity were measured using PET during an isoglycemic clamp. Mean whole body insulin sensitivity was lower by 34% (P

Published
2017

13. New sectorized implantable microelectrode fabrication, packaging and ageing for neural sensing and stimulation

Author

F. Sauter-Starace, Christine Henry, David Guiraud, Jean-Louis Divoux, C. Pudda, B. Icard, F. Baleras, M. Cochet, Charles-Henri Malbert, Sandrine Maubert, M. Rovetta, C. Chabrol, J. Oziat, F. Bottausci, Département Microtechnologies pour la Biologie et la Santé (DTBS), Commissariat à l'énergie atomique et aux énergies alternatives - Laboratoire d'Electronique et de Technologie de l'Information (CEA-LETI), Direction de Recherche Technologique (CEA) (DRT (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Direction de Recherche Technologique (CEA) (DRT (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Clinatec - Centre de recherche biomédicale Edmond J.Safra (SCLIN), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Centre Hospitalier Universitaire [Grenoble] (CHU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Grenoble Alpes (UGA), Artificial movement and gait restoration (DEMAR), Laboratoire d'Informatique de Robotique et de Microélectronique de Montpellier (LIRMM), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria), AXONIC - OBELIA dept, MXM-Laboratoires de Techologies Médicales, US 1395 ANI-SCAN [INRA], Institut National de la Recherche Agronomique (INRA), Sorin Group [Clamart], Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Université Joseph Fourier - Grenoble 1 (UJF)-Centre Hospitalier Universitaire [Grenoble] (CHU)-Institut National de la Santé et de la Recherche Médicale (INSERM), and Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Inria Sophia Antipolis - Méditerranée (CRISAM)

Subjects
Microelectrode, chemistry.chemical_compound, Fabrication, Materials science, Reliability (semiconductor), Silicone, Specific test, chemistry, Parylene, [SDV]Life Sciences [q-bio], Electrode, Thin film, Biomedical engineering
Abstract

Événement(s) lié(s) : - (NER); International audience; This paper describes the fabrication and the packaging of a flexible parylene-based multi-contact electrode embedded in a silicone-based cuff. This type of electrode is well suited for peripheral nerve recording and offers improved spatial selectivity. We conducted mechanical and electrical tests for assessing the reliability by using an accelerated lifetime protocol. Test structures made with platinum sandwiched with parylene C were designed. The accelerated lifetime soaking tests in phosphate buffered saline (PBS) solution at 67 degrees C showed a longer life time (approximatively 4.5 years) with a dehydration bake introduction in the process flow and a parylene thickness increase. A specific test bench was developed for the mechanical cycling and for evaluating the mechanical robustness of the thin film devices.

Published
2015

14. Brain metabolism and dopamine transporter binding during chronic vagal stimulation

Author

Charles-Henri Malbert, Eric Bobillier, Sylvie Guerin, Nicolas Coquery, and Jean-Louis Divoux

Subjects
medicine.medical_specialty, Vagal stimulation, biology, Chemistry, General Neuroscience, Dopaminergic, Biophysics, Metabolism, lcsh:RC321-571, Endocrinology, Internal medicine, medicine, biology.protein, Neurology (clinical), lcsh:Neurosciences. Biological psychiatry. Neuropsychiatry, Dopamine transporter
Published
2015

15. Selective ENG recordings using a multi-contact cuff electrode

Author

Pawel Maciejasz, Sandrine Maubert, A. Bourgerette, N. Bourquin, S. Gharbi, C. Rubeck, Jean-Louis Divoux, Christine Henry, Stéphane Bonnet, Vincent Agache, F. Sauter-Starace, O. Fuchs, Commissariat à l'énergie atomique et aux énergies alternatives - Laboratoire d'Electronique et de Technologie de l'Information (CEA-LETI), Direction de Recherche Technologique (CEA) (DRT (CEA)), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA), Département Microtechnologies pour la Biologie et la Santé (DTBS), Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Commissariat à l'énergie atomique et aux énergies alternatives (CEA)-Direction de Recherche Technologique (CEA) (DRT (CEA)), Artificial movement and gait restoration (DEMAR), Laboratoire d'Informatique de Robotique et de Microélectronique de Montpellier (LIRMM), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria), AXONIC - OBELIA dept, MXM-Laboratoires de Techologies Médicales, Sorin Group [Clamart], PIA-PSPC 'INTENSE' Project, Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Inria Sophia Antipolis - Méditerranée (CRISAM), Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-Laboratoire d'Informatique de Robotique et de Microélectronique de Montpellier (LIRMM), and Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)

Subjects
[SPI.OTHER]Engineering Sciences [physics]/Other, Materials science, 0206 medical engineering, Cuff electrode, 02 engineering and technology, Neurophysiology, 020601 biomedical engineering, 03 medical and health sciences, Microelectrode, chemistry.chemical_compound, 0302 clinical medicine, Parylene, chemistry, Peripheral nerve, Cuff, Electrode, 030217 neurology & neurosurgery, Microfabrication, Biomedical engineering
Abstract

International audience; This paper describes the design, microfabrication, characterization and experimental validation of a 6-contact cuff electrode embedded in a parylene-based flexible support. This type of electrode is well suited for both peripheral nerve recording and stimulation and offers improved spatial selectivity as compared to conventional ring electrodes. Both measured and modeled impedance spectra are detailed. An experimental validation is performed on an earthworm with both multi-contact cuff (MCC) electrode recording and ring stimulation electrodes. Single fiber action potentials, elicited by the electrical stimulation, are well discriminated on the 6 contacts. Spontaneous activity is also recorded with burst of spikes.

Published
2013

16. Development of an implantable transverse intrafascicular multichannel electrode (TIME) system for relieving phantom limb pain

Author

Silvestro Micera, Paolo Maria Rossini, Ken Yoshida, David Guiraud, Winnie Jensen, Thomas Stieglitz, Xavier Navarro, Jean-Louis Divoux, Center for Sensory-Motor Interaction (SMI), Aalborg University [Denmark] (AAU), Scuela Santa Anna (SSSA), Scuola Universitaria Superiore Sant'Anna [Pisa] (SSSUP), Cell Biology, Physiology and Immunology, Department of Microsystems Engineering [Freiburg] (IMTEK), University of Freiburg [Freiburg], Artificial movement and gait restoration (DEMAR), Laboratoire d'Informatique de Robotique et de Microélectronique de Montpellier (LIRMM), Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria), AXONIC - OBELIA dept, MXM-Laboratoires de Techologies Médicales, Biomedical Robotics and Biomicrosystems Lab - UCBM, Università Campus Bio-Medico di Roma / University Campus Bio-Medico of Rome ( UCBM), Indiana University - Purdue University Indianapolis (IUPUI), Indiana University System, European Project: 224012,EC:FP7:ICT,FP7-ICT-2007-2,TIME(2008), and Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Inria Sophia Antipolis - Méditerranée (CRISAM)

Subjects
multichannel microstimulation, medicine.medical_treatment, Finite Element Analysis, Phantom limb, Pain, human machine interface, phantoms, Electric Stimulation Therapy, Phantom limb pain, 03 medical and health sciences, 0302 clinical medicine, Neuromuscular stimulation, Amputees, user interfaces, Animals, Humans, Pain Management, Medicine, Microstimulation, Effective treatment, Peripheral Nerves, prosthetics, [SPI.NANO]Engineering Sciences [physics]/Micro and nanotechnologies/Microelectronics, 030304 developmental biology, 0303 health sciences, business.industry, Time system, medicine.disease, equipment and supplies, nerve stump, Electric Stimulation, Electrodes, Implanted, Rats, neuromuscular stimulation, body regions, implantable transverse intrafascicular multichannel electrode system, phantom limb pain, Phantom Limb, Amputation, biomedical electrodes, Human–machine interface, business, 030217 neurology & neurosurgery, Biomedical engineering
Abstract

International audience; Phantom limb pain frequently follows amputation. Currently there is no fully effective treatment available. Our aim is to develop an innovative Human Machine Interface (HMI) where we apply multi-channel microstimulation to the nerve stump of an amputee subject to manipulate the phantom limb sensations and explore the possibility of using microstimulation as a treatment for phantom limb pain.

Published
2010

17. Original electronic design to perform epimysial and neural stimulation in paraplegia

Author

David Guiraud, Thomas Stieglitz, Gérard Taroni, Jean-Louis Divoux, Publica, Artificial movement and gait restoration (DEMAR), Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria)-Laboratoire d'Informatique de Robotique et de Microélectronique de Montpellier (LIRMM), Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM), This work was supported by the European Community through the SUAW project under Grant BMH4-CT965-1501., Laboratoire d'Informatique de Robotique et de Microélectronique de Montpellier (LIRMM), Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Inria Sophia Antipolis - Méditerranée (CRISAM), Institut National de Recherche en Informatique et en Automatique (Inria)-Institut National de Recherche en Informatique et en Automatique (Inria), Department of Microsystems Engineering [Freiburg] (IMTEK), University of Freiburg [Freiburg], and Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS)-Université de Montpellier (UM)-Inria Sophia Antipolis - Méditerranée (CRISAM)

Subjects
medicine.medical_specialty, Implanted electronic device, Neuroprosthetics, Computer science, 0206 medical engineering, Electrode modelling, Biomedical Engineering, Electric Stimulation Therapy, Stimulation, 02 engineering and technology, Integrated circuit, Synaptic Transmission, law.invention, 03 medical and health sciences, Cellular and Molecular Neuroscience, Physical medicine and rehabilitation, Electric Power Supplies, 0302 clinical medicine, law, Functional electrical stimulation, medicine, Humans, Spinal cord-injured patient, Simulation, Neurons, Paraplegia, Epimysium, Equipment Design, medicine.disease, 020601 biomedical engineering, Electrodes, Implanted, Neuromuscular stimulation, medicine.anatomical_structure, Neuroprosthesis, Neural stimulation, Electronic design, [SDV.IB]Life Sciences [q-bio]/Bioengineering, Electronics, Algorithms, 030217 neurology & neurosurgery
Abstract

This paper presents an original electronic architecture to manage epimysial and neural stimulation using the same implantable device. All the muscles needed to achieve lower limb movements such as standing and walking can thus be activated. Mainly for surgical reasons, some muscles need to be stimulated through different inputs: epimysium or motor nerve. We developed an electronic solution, including the design of an application-specific integrated circuit, to meet the requirements of both types of stimulation. Five years after the successful implantation of the system, we were able to evaluate the system's performance. The patient is still using the system at home and no failure occurred during this 5-year period. We conclude that the electronic design not only provides a unique investigative tool for research, but that it can also be used to restore the motor function of the lower limb. This technology has an advantage over external stimulation because the patient can safely use the system at home. However, improvements such as lower power consumption, and thus greater autonomy, are needed. We further conclude that the modelling of the electrical behaviour of the electrodes is reliable and the estimated parameter values are homogeneous and consistent for the same type of electrode. Thus, the three parameters of the first-order model can be identified from an acute animal experiment and provide a means to optimize the design of the output stage of implanted stimulators.

Published
2006

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