Neurostimulation for Pain
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Microelectrode Implants for Spinal Cord Stimulation in Rats
Microelectrode Implants for Spinal Cord Stimulation in Rats Thesis by Mandheerej Singh Nandra In Partial Fulfillment of the Requirements for the Degree of Doctor of Philosophy California Institute of Technology Pasadena, California 2014 (Defended on Sept 24, 2014) ii © 2014 Mandheerej Nandra All Rights Reserved iii Acknowledgements First and foremost, I must express my most sincere gratitude towards my advisor, Prof. Yu-Chong Tai. Your depth of knowledge and sheer brilliance have guided and inspired me throughout my time at Caltech, and I will never forget your unwavering support for me through countless challenging times during this project, and the life lessons I have learned from you. It is truly my honor to be a part of your lab. This dissertation could only be achieved with the dedicated effort from the Edgerton lab at UCLA. I am grateful that Dr. Reggie Edgerton has given me this opportunity to join in the effort to push the boundaries of spinal cord research. I am forever in debt to the tireless work ethic of Parag Gad and Dr. Jaehoon Choe for their work with the animals used in this study and their concise analysis. I would like to thank my various colleagues through the years at the Caltech Micromachining Lab. None of the work in this thesis would be possible without Dr. Damien Rodger’s work in developing microelectrode fabrication technology at our lab. Dr. Angela Tooker and Dr. Wen Li were excellent mentors in teaching me all I needed to know in the lab. Thank you, Dr. Luca Giacchino and Dr. Ray Huang, for your friendship as we progressed through Caltech together. -
Precision™ Spinal Cord Stimulator System Clinician Manual Directions for Use
Precision™ Spinal Cord Stimulator System Clinician Manual Directions for Use 91083273-04 CAUTION: Federal law restricts this device to sale, Content: 92162683 REV A distribution and use by or on the order of a physician. Precision™ Spinal Cord Stimulator System Clinician Manual Guarantees Boston Scientific Corporation reserves the right to modify, without prior notice, information relating to its products in order to improve their reliability or operating capacity. Drawings are for illustration purposes only. Trademarks All trademarks are the property of their respective holders. Clinician Manual 91083273-04 ii of iv Table of Contents Manual Overview ...........................................................................................................................1 Device and Product Description ..................................................................................................2 Implantable Pulse Generator ...........................................................................................................2 Leads ...............................................................................................................................................2 Lead Extension ................................................................................................................................2 Lead Splitter ......................................................................................................................................3 Indications for Use ........................................................................................................................4 -
Neurotechnologies and Brain Computer Interface
From Technologies to Market Sample Neurotechnologies and brain computer interface Market and Technology analysis 2018 LIST OF COMPANIES MENTIONED IN THIS REPORT 240+ slides of market and technology analysis Abbott, Ad-tech, Advanced Brain Monitoring, AdvaStim, AIST, Aleva Neurotherapeutics, Alphabet, Amazon, Ant Group, ArchiMed, Artinis Medical Systems, Atlas Neuroengineering, ATR, Beijing Pins Medical, BioSemi, Biotronik, Blackrock Microsystems, Boston Scientific, Brain products, BrainCo, Brainscope, Brainsway, Cadwell, Cambridge Neurotech, Caputron, CAS Medical Systems, CEA, Circuit Therapeutics, Cirtec Medical, Compumedics, Cortec, CVTE, Cyberonics, Deep Brain Innovations, Deymed, Dixi Medical, DSM, EaglePicher Technologies, Electrochem Solutions, electroCore, Elmotiv, Endonovo Therapeutics, EnerSys, Enteromedics, Evergreen Medical Technologies, Facebook, Flow, Foc.us, G.Tec, Galvani Bioelectronics, General Electric, Geodesic, Glaxo Smith Klein, Halo Neurosciences, Hamamatsu, Helius Medical, Technologies, Hitachi, iBand+, IBM Watson, IMEC, Integer, Integra, InteraXon, ISS, Jawbone, Kernel, LivaNova, Mag and More, Magstim, Magventure, Mainstay Medical, Med-el Elektromedizinische Geraete, Medtronic, Micro Power Electronics, Micro Systems Technologies, Micromed, Microsoft, MindMaze, Mitsar, MyBrain Technologies, Natus, NEC, Nemos, Nervana, Neurable, Neuralink, NeuroCare, NeuroElectrics, NeuroLutions, NeuroMetrix, Neuronetics, Neuronetics, Neuronexus, Neuropace, Neuros Medical, Neuroscan, NeuroSigma, NeuroSky, Neurosoft, Neurostar, Neurowave, -
Management of Chronic and Neuropathic Pain with 10 Khz Spinal Cord Stimulation Technology: Summary of Findings from Preclinical and Clinical Studies
biomedicines Review Management of Chronic and Neuropathic Pain with 10 kHz Spinal Cord Stimulation Technology: Summary of Findings from Preclinical and Clinical Studies Vinicius Tieppo Francio 1,* , Keith F. Polston 1 , Micheal T. Murphy 1 , Jonathan M. Hagedorn 2 and Dawood Sayed 3 1 Department of Rehabilitation Medicine, The University of Kansas Medical Center, Kansas City, KS 66160, USA; [email protected] (K.F.P.); [email protected] (M.T.M.) 2 Department of Anesthesiology and Perioperative Medicine, Division of Pain Medicine, Mayo Clinic, Rochester, MN 55905, USA; [email protected] 3 Department of Anesthesiology, The University of Kansas Medical Center, Kansas City, KS 66160, USA; [email protected] * Correspondence: [email protected] Abstract: Since the inception of spinal cord stimulation (SCS) in 1967, the technology has evolved dramatically with important advancements in waveforms and frequencies. One such advance- ment is Nevro’s Senza® SCS System for HF10, which received Food and Drug and Administration (FDA) approval in 2015. Low-frequency SCS works by activating large-diameter Aβ fibers in the lateral discriminatory pathway (pain location, intensity, quality) at the dorsal column (DC), creating paresthesia-based stimulation at lower-frequencies (30–120 Hz), high-amplitude (3.5–8.5 mA), and µ Citation: Tieppo Francio, V.; Polston, longer-duration/pulse-width (100–500 s). In contrast, high-frequency 10 kHz SCS works with a K.F.; Murphy, M.T.; Hagedorn, J.M.; proposed different mechanism of action that is paresthesia-free with programming at a frequency Sayed, D. Management of Chronic of 10,000 Hz, low amplitude (1–5 mA), and short-duration/pulse-width (30 µS). -
Non-Invasive Neurostimulation Methods for Acute and Preventive Migraine Treatment—A Narrative Review
Journal of Clinical Medicine Review Non-Invasive Neurostimulation Methods for Acute and Preventive Migraine Treatment—A Narrative Review Stefan Evers 1,2 1 Faculty of Medicine, University of Münster, 48153 Münster, Germany; [email protected] 2 Department of Neurology, Lindenbrunn Hospital, 31863 Coppenbrügge, Germany Abstract: Neurostimulation methods have now been studied for more than 20 years in migraine treatment. They can be divided into invasive and non-invasive methods. In this narrative review, the non-invasive methods are presented. The most commonly studied and used methods are vagal nerve stimulation, electric peripheral nerve stimulation, transcranial magnetic stimulation, and transcranial direct current stimulation. Other stimulation techniques, including mechanical stimulation, play only a minor role. Nearly all methods have been studied for acute attack treatment and for the prophylactic treatment of migraine. The evidence of efficacy is poor for most procedures, since no stimulation device is based on consistently positive, blinded, controlled trials with a sufficient number of patients. In addition, most studies on these devices enrolled patients who did not respond sufficiently to oral drug treatment, and so the role of neurostimulation in an average population of migraine patients is unknown. In the future, it is very important to conduct large, properly blinded and controlled trials performed by independent researchers. Otherwise, neurostimulation methods will only play a very minor role in the treatment of migraine. Keywords: neurostimulation; vagal nerve; supraorbital nerve; transcranial magnetic stimulation Citation: Evers, S. Non-Invasive Neurostimulation Methods for Acute and Preventive Migraine 1. Introduction Treatment—A Narrative Review. J. One of the recent innovations in migraine treatment was the detection of several types Clin. -
History, Applications, and Mechanisms of Deep Brain Stimulation
NEUROLOGICAL REVIEW SECTION EDITOR: DAVID E. PLEASURE, MD History, Applications, and Mechanisms of Deep Brain Stimulation Svjetlana Miocinovic, MD, PhD; Suvarchala Somayajula, MD; Shilpa Chitnis, MD, PhD; Jerrold L. Vitek, MD, PhD eep brain stimulation (DBS) is an effective surgical treatment for medication-refractory hypokinetic and hyperkinetic movement disorders, and it is being explored for a variety of other neurological and psychiatric diseases. Deep brain stimulation has been Food and Drug Administration–approved for essential tremor and Parkinson disease and has Da humanitarian device exemption for dystonia and obsessive-compulsive disorder. Neurostimulation is the fruit of decades of both technical and scientific advances in the field of basic neuroscience and functional neurosurgery. Despite the clinical success of DBS, the therapeutic mechanism of DBS re- mains under debate. Our objective is to provide a comprehensive review of DBS focusing on move- ment disorders, including the historical evolution of the technique, applications and outcomes with an overview of the most pertinent literature, current views on mechanisms of stimulation, and de- scription of hardware and programming techniques. We conclude with a discussion of future devel- opments in neurostimulation. JAMA Neurol. 2013;70(2):163-171. Published online November 12, 2012. doi:10.1001/2013.jamaneurol.45 Deep brain stimulation (DBS) has evolved recovery.1-4 New applications continue to as an important therapy for the treat- emerge, encouraged by past successes and ment of essential tremor, Parkinson dis- the fact that DBS effects are reversible al- ease (PD), and dystonia, and it is also lowing exploration of new targets and ap- emerging for the treatment of medication- plications not previously possible with le- refractory psychiatric disease. -
State-Of-The-Art BCI Device Technology
State-of-the-Art BCI Device Technology Jose L. Contreras-Vidal, Ph.D. University of Houston STATE OF THE ART PATIENT BCI SOLUTIONS (CORTICAL INVASIVE AND NONINVASIVE, PERIPHERAL) Jose L Contreras-Vidal, PhD Hugh Roy and Lillie Cranz Cullen University Professor Department of Electrical & Computer Engineering University of Houston http://www.ee.uh.edu/faculty/contreras-vidal https://www.facebook.com/UHBMIST Scope • “Neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities” (FDA’s working definition of BCI) • BCI Devices for Patients with Paralysis and Amputation • Cortical (invasive and noninvasive) and Peripheral • Human investigational studies of BCI devices reported in clinicaltrials.gov Working definition of BCI systems Neural interface – Recording electrode 1 3 Prosthetic, exoskeleton, robotic or virtual effector (usually + shared control) 2 Feedback system – Definitions: Neural stimulator 1 – interface, physical/virtual effector Closed loop 2 – interface, physical effector feedback 3 – interface, feedback Sensor – response system Neural Interface to prosthetic, exoskeleton, robotic or virtual effector (definition 1) Research Clinical Studies Cleared/Approved Myoelectric prosthetic High DOF prosthetic, myoelectric + shared control Invasive cortical interface EEG interface BCI systems Implantable myoelectric sensor Exoskeleton Novel cortical interface * Dry contact EEG * * Not reviewed here. Peripheral nerve sensors * Neural Interface to prosthetic, exoskeleton, robotic -
Neuropathic Pain Case
Author Information Full Names: Erica Patel, MD Kiran V. Patel, MD Presenting Symptom: Burning in right foot> Chronic low back pain Case Specific Diagnosis: Chronic low back pain and radicular pain Learning Objectives: 1. To identify the factors affecting failure of trials (<50% pain reduction in pain for trial period). 2. Demonstrate ways to improve the success of spinal cord stimulation (SCS) trial. 3. Discuss and review literature on SCS efficacy in treating various chronic pain syndromes. History: A 75 year old female retired librarian with a past medical history of DM, and history of L5-S1 laminotomy/microdiscectomy ten years ago who presents with chronic low back pain and right burning foot pain for the past year. In the past six months the pain has increased in intensity. She denies any recent falls or trauma. She denies any bladder or bowel incontinence, weight loss, fever, chills or weakness of her lower extremities. She is interested in minimally invasive interventions to treat her pain and wants to avoid surgery if possible. The pain occurs daily and begins in the middle of the low back and travels to the sole of the right foot associated with a burning sensation. This pain is affecting her quality of life. She is unable to walk for more than 15 minutes due to the worsening back and leg pain. Her sleep is fragmented secondary to the burning in the right foot. Aggravating factors include bending, walking, and sitting. Alleviating factors include a TENS unit and rest. She follows with her primary regularly and states her “diabetes -
Pain Management Centre Spinal Cord Stimulator Pathway
Pain Management Centre Spinal Cord Stimulator Pathway Patient Information Leaflet for: Neuromodulation Pathway Author/s: K Dyer, B Roughsedge, G Daniels Author/s titles: Clinical Nurse Manager, Clinical Psychologist, Specialist Physiotherapist Approved by: Patient Information Forum Date approved: 03/01/2019 Review date: 03/01/2022 Available via Trust Docs Version: 7 Trust Docs ID:10179 Pain Management Centre Spinal Cord Stimulator (SCS) Pathway Your Consultant has suggested that you might be suitable for a trial of spinal cord stimulation (SCS). National Institute for Health and Clinical Excellence (NICE) guidelines for SCS state that “spinal cord stimulation should be provided only after an assessment by a multidisciplinary team experienced in chronic pain assessment and management of people with spinal cord stimulation devices, including experience in the provision of ongoing monitoring and support of the person assessed.” (NICE 2008). The multi-disciplinary team comprises Consultants, Specialist Nurses, Clinical Psychologists, Occupational Therapist & Specialist Physiotherapists, all who have many years’ experience of managing chronic pain with spinal cord stimulation. We have developed a pathway to comply with this guidance, which will start when the consultant recommends you for assessment by the spinal cord stimulator multidisciplinary team. The Pathway - what happens next? The first appointment in the pathway is a Technical Session. This is a group appointment and you are welcome to bring a relative/ friend with you. During this session we will: • Explain what spinal cord stimulation is • Demonstrate the types of equipment used • Discuss the risks associated with the device • Discuss the potential benefit you may receive from SCS • Discuss the trial and post op instructions if you proceed You will also be given an appointment with two members of the multi-disciplinary team. -
Spinal Cord Stimulation: a Nonopioid Alternative for Chronic Pain Management
PRACTICE | INNOVATIONS CPD Spinal cord stimulation: a nonopioid alternative for chronic pain management Aaron Hong MD MSc, Vishal Varshney MD, Gregory M.T. Hare MD PhD, C. David Mazer MD n Cite as: CMAJ 2020 October 19;192:E1264-7. doi: 10.1503/cmaj.200229 hronic pain affects 1 in 5 Canadians and is associated 1 with considerable socioeconomic burden. Although opi- KEY POINTS oids have been the mainstay of treatment, they have lost Spinal cord stimulation masks pain signals through a Cfavourability owing to crises of addiction, abuse, tolerance and • transcutaneous implantable electric pulse generator. dependence.1,2 Consequently, alternatives — including cognitive • Spinal cord stimulation is safe, efficacious and cost-effective in behavioural therapy, physical rehabilitation, non-opiate pharma- chronic pain management of neuropathic pain conditions, 1,3 cology and integrative therapies — have been developed. including failed back surgery syndrome, chronic regional pain When conventional therapies produce unacceptable adverse syndrome and chronic peripheral neuropathies. effects or do not provide sufficient pain relief, spinal cord • Newer spinal cord stimulation technologies are expanding stimulation (neuromodulation) may offer a rescue option, either clinical indications such as visceral and ischemic pain, with alone or in conjunction with other modalities.3,4 potential for further improved efficacy. Neuromodulation, defined as the alteration of nerve activity • Increased awareness of and access to spinal cord through targeted stimulus delivery, was first introduced in stimulation therapy may allow more Canadians to benefit 2,3,5 from relief of intractable chronic pain and may reduce 1967. It is based on the principle of electrically stimulating the opioid consumption. -
1. Summary of Safety and Effectiveness Data
1. Summary Of Safety And Effectiveness Data 1.1 General Information 1.1.1 Device Generic Name Totally Implanted Spinal Cord Stimulator for Pain Relief 1.1.2 Device Trade Name Genesis Neurostimulation (IPG) System 1.1.3 Applicant’s Name and Address Advanced Neuromodulation Systems (ANS), Inc. 6501 Windcrest Drive, Suite 100 Plano, Texas 75024 1.1.4 PMA Number P010032 1.1.5 Date of Notice of Approval to the Applicant November 21, 2001 1.2 Indications for Use ANS Genesis Neurostimulation (IPG) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. 1.3 Device Description 1.3.1 Genesis Neurostimulation System The Genesis Neurostimulation (IPG) System consists of the following components: Model 3608 Implanted Pulse Generator (IPG), Model 3850 Patient Programmer, Model 1232 Programming Wand, and Model 1210 Patient Magnet. The Genesis Neurostimulation (IPG) System is intended to be used with the following ANS’ legally marketed components: · percutaneous lead models 3143, 3146, 3153, 3156, 3183 and 3186 · surgical lead models 3222, 3240, 3244 and 3280 · extension models 3382, 3383, 3341, 3342 and 3343 · ANS TS8 test stimulation system. The IPG is connected to a lead with four or eight electrodes, either directly or with a lead extension. The electrodes contact the patient along the spinal cord. The IPG is implanted in a subcutaneous pocket, and receives radio frequency (RF) programming signals from an external Patient 1 of 17 Programmer. -
Wireless, Battery-Free, and Fully Implantable Electrical
Burton et al. Microsystems & Nanoengineering (2021) 7:62 Microsystems & Nanoengineering https://doi.org/10.1038/s41378-021-00294-7 www.nature.com/micronano ARTICLE Open Access Wireless, battery-free, and fully implantable electrical neurostimulation in freely moving rodents Alex Burton1,SangMinWon 2, Arian Kolahi Sohrabi3, Tucker Stuart1, Amir Amirhossein1,JongUkKim4, ✉ ✉ ✉ Yoonseok Park 4, Andrew Gabros3,JohnA.Rogers 4,5,6,7,8,9 , Flavia Vitale10 ,AndrewG.Richardson 3 and ✉ Philipp Gutruf 1,11,12 Abstract Implantable deep brain stimulation (DBS) systems are utilized for clinical treatment of diseases such as Parkinson’s disease and chronic pain. However, long-term efficacy of DBS is limited, and chronic neuroplastic changes and associated therapeutic mechanisms are not well understood. Fundamental and mechanistic investigation, typically accomplished in small animal models, is difficult because of the need for chronic stimulators that currently require either frequent handling of test subjects to charge battery-powered systems or specialized setups to manage tethers that restrict experimental paradigms and compromise insight. To overcome these challenges, we demonstrate a fully implantable, wireless, battery-free platform that allows for chronic DBS in rodents with the capability to control stimulation parameters digitally in real time. The devices are able to provide stimulation over a wide range of frequencies with biphasic pulses and constant voltage control via low-impedance, surface-engineered platinum electrodes. The devices utilize off-the-shelf components and feature the ability to customize electrodes to enable 1234567890():,; 1234567890():,; 1234567890():,; 1234567890():,; broad utility and rapid dissemination. Efficacy of the system is demonstrated with a readout of stimulation-evoked neural activity in vivo and chronic stimulation of the medial forebrain bundle in freely moving rats to evoke characteristic head motion for over 36 days.