DOCSLIB.ORG

Neurostimulation for Pain

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Neurostimulation for Pain PRINTER-FRIENDLY VERSION AT PAINMEDICINENEWS.COM Neurostimulation for Pain TORY MCJUNKIN, MD PAUL J. LYNCH, MD NICOLE E. BERARDONI, MD All rightsFounder, reserved. Arizona Reproduction Pain Specialists in wholeFounder, or Arizona in part Pain without Specialists permission is prohibited.Research Director, Scottsdale, AZ Scottsdale, AZ Arizona Pain Specialists Assistant Professor of Anesthesiology, Clinical Instructor of Anesthesiology, Diagnostic Radiology, MayoCopyright Clinic College © of 2009 Medicine McMahon MayoPublishing Clinic College Group of Medicine unless otherwiseMaricopa noted. Medical Center Rochester, Minnesota Rochester, Minnesota Phoenix, Arizona Dr. McJunkin is a consultant for St. Jude Medical and Boston Scientific. Dr. Lynch is a consultant for St. Jude Medical. Dr. Berardoni has no relevant financial conflicts to disclose. hronic pain is a pandemic that affects approximately 11% of people in the United States, and is estimated to cost Cthe nation $100 billion per year in medical expenses, lost income, and decreased productivity.1,2 Chronic pain interferes with all aspects of life, including personal enjoyment, work, and relationships. Although pain is universal, the etiology of many painful conditions is not well understood, making treatment difficult. PAIN MEDICINE NEWS SPECIAL EDITION • DECEMBER 2009 9 Neuromodulation to sense previously perceived pain. The intensity of the Forms of neuromodulation were used long before the stimulator can be changed, the pattern of the electri- discovery of electricity. The Egyptians first attempted cal field can be varied, and the system can be turned electric stimulation to treat pain as early as 2,500 BC, as on and off as necessary to provide optimal pain relief seen on stone carvings depicting electric catfish being as experienced by the patient. Currently available IPG placed on people.3 The torpedo fish, which also gener- devices are listed in Table 1. Fluoroscopic images of ates electric currents, was used to treat pain and com- device leads are shown in the Figure. mon maladies like headaches and arthritis during the A stimulator trial is performed prior to permanently time of Socrates.4 Electric shocks from these animals implanting the IPG and leads. In a stimulator trial, 1 or canAll reach rights 220 reserved. volts, enough Reproduction to kill a human in adult. whole In or2 inleads part containing without varying permission amounts isof prohibited.electrodes are ancient Greece and Rome, the shocks from the species implanted percutaneously into the epidural space (SCS) Torpedo nobiliana were used as a treatment for gout, or close to pain-generating nerves (PNS) with local anes- headache, and otherCopyright sources ©of pain.20094 McMahon Publishingthetic and Group IV drug unless sedation. otherwise If pain and function noted. improve Grounded in the theory that non-noxious stimuli can by a margin of 50% or more (assessed on a visual ana- reduce noxious pain perception, modern neuromod- log scale [VAS] and through careful monitoring of the ulation works by introducing an electric current near patient over 3-7 days), the patient can receive permanent the source of chronic pain impulses or along pain path- electrodes and the IPG can be surgically implanted. ways. In 1967, Shealy introduced neuromodulation into contemporary medicine; however, the approach did not SPINAL CORD STIMULATION gain popularity for the treatment of pain until the mid- Spinal cord stimulation has proven to be an effec- 1980s.5,6 tive treatment modality in improving daily function and Stimulation is becoming increasingly popular for the quality of life for many patients suffering from severe treatment of refractory pain conditions. It is reversible, neuropathic pain of various causes, most commonly safe, cost-effective, and nonpharmacologic. The most chronic back and limb pain7 (Table 2). However, treat- common forms of stimulation offered to treat pain are ment of chronic neuropathic pain in the region of the spinal cord stimulation (SCS), peripheral nerve stimu- face, neck, head, and low back are challenging for pain lation (PNS), motor cortex stimulation, and deep brain specialists. The pain is typically refractory to many of stimulation. This review focuses on SCS and PNS. the conventional treatment options, including med- Most implantable pulse generators (IPGs) are ical therapies (nonsteroidal anti-inflammatory drugs rechargeable, programmable, and can connect to 1 or [NSAIDs], anticonvulsants, local anesthetics, antide- 2 leads. The IPG produces a low-voltage current, which pressants, and opiates), physical therapy, and nerve creates a sensation that blocks the ability of the brain blocks or ablations.8 Table 1. Comparison of Small, Rechargeable IPG Devices Device, Days Between Manufacturer Size FDA Battery Life Recharge Power Delivery Eon Mini 18 cc 10 yr 121 Constant current St. Jude Medical Precision 22 cc 5 yr 61 Constant current Boston Scientific RestoreULTRA 22 cc 9 yr 54 Constant voltage Medtronic IPG, implantable pulse generator Source: Clinician’s manual for Eon Mini Neurostimulation System. Plano, TX: St. Jude Medical Neurostimulation; 2008. Precision IPG [product brochure]. Valencia, CA: Boston Scientific; 2007. RestoreULTRA [product brochure]. Minneapolis, MN: Medtronic; 2008. 10 INDEPENDENTLY DEVELOPED BY MCMAHON PUBLISHING All rights reserved. Reproduction in whole or in part without permission is prohibited. Copyright © 2009 McMahon Publishing Group unless otherwise noted. Figure. Fluoroscopic images of leads. Images provided by ArizonaPain.com. PERIPHERAL NERVE STIMULATION subcutaneous placement of electrical leads over the Peripheral nerve stimulation is a type of neuro- generalized area of pain (eg, lumbar leads for axial lum- modulation that is becoming increasingly popular for bar pain). An advantage of PNS over SCS is the ability the treatment of many causes of chronic pain and to place the lead directly adjacent to an affected nerve peripheral neuralgias (Table 3). This innovative treat- or in the area of pain, and the ability to provide relief to ment works by delivering low-level electric impulses areas that may be difficult to reach with SCS. close to pain-generating nerves that interfere with the Head, Neck, and Facial Pain perception of nociceptive pain.9 The first through third cervical nerve roots are com- Peripheral nerve stimulation can be further divided monly involved when a patient presents with head, into 2 entities. The first is PNS of an identifiable pain- neck, and facial pain. Spinal nerve roots are not always generating nerve (such as the sciatic nerve in a patient the cause of these cephalad neuralgias and muscle con- with foot pain or the occipital nerves in a patient tractures. Patients who have failed other treatments for with occipital neuralgia). The second type of PNS, their pain have responded positively to PNS. In 2007, peripheral nerve field stimulation (PNfS), involves the Melvin et al conducted a study of patients with occipi- tal headaches. After 4 weeks of receiving PNS for their headaches, 46% of the patients rated the relief as excel- Table 2. Conditions Effectively lent, and at 12 weeks no patients enrolled in the study Managed With Spinal Cord Stimulation7 reported poor pain relief.10 Percutaneous implantation of peripheral stimulator leads has been shown to provide good to excellent results in treating intractable occip- Ischemic vascular ital neuralgia, which has been a suggested trigger for Peripheral vascular disease migraines.8 In a clinical investigation of patients receiv- Refractory angina ing PNS for craniofacial pain, 73% of the participants experienced significant improvement in pain intensity Emerging uses in the first 3 months.10 Chronic pancreatitis Chronic pelvic pain Facial pain (nucleus caudalis stimulation) Table 3. Conditions That May Be Idiopathic neuropathic foot pain Effectively Treated by PNS and PNfS Neuropathic pain Axial pain (cervical, thoracic, lumbar, sacral) Brachial plexus neuropathy Cervicogenic headaches Complex regional pain syndrome Chronic pelvic/testicular pain Peripheral neuropathy Complex regional pain syndrome (I & II), RSD Postherpetic neuralgia Migraines/chronic daily headaches (C1-C3 PNS) Post-laminectomy syndrome Post-laminectomy syndrome Post-thoracotomy syndrome Occipital neuralgia (C1 PNS) Phantom limb pain Radiculitis (cervical, thoracic, lumbar, sacral) PNfS, peripheral nerve field stimulation; PNS, peripheral nerve stimu- lation; RSD, reflex sympathetic dystrophy PAIN MEDICINE NEWS SPECIAL EDITION • DECEMBER 2009 11 Case Report Plan SCS trial with 2 lumbar epidural leads compared with PNS trial with 2 lumbar axial percutaneous leads. Chief Complaint: Chronic Low Back Pain (Without Radiculopathy) Trial History of present illness: The patient is a The patient underwent implantation of a trial 68-year-old man with a long history of lower back spinal cord stimulator with 2 epidural leads in the pain. The patient had been treated with NSAIDs, thoracolumbar region, as well as 2 peripheral field Allnarcotics, rights and reserved. physical therapy,Reproduction as well as inepidurals whole or in part without permission is prohibited. leads in the lumbar region. Two SJM Octrode and facet injections. The patient underwent spinal (St. Jude Medical) leads were advanced from the fusion 2 years ago without significant pain relief. 14-gauge Tuohy needles at the L2-L3 epidural inter- On presentation,Copyright the patient © 2009 describes McMahon the pain Publishing Group unless otherwise
Load more

Recommended publications
  • 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.
    [Show full text]
  • 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
    [Show full text]
  • 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,
    [Show full text]
  • 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).
    [Show full text]
  • 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.
    [Show full text]
  • 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.
    [Show full text]
  • 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
    [Show full text]
  • 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
    [Show full text]
  • 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.
    [Show full text]
  • 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.
    [Show full text]
  • 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.
    [Show full text]
  • 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.
    [Show full text]