Electro-Magnetic Device Ends Migraine Pain

FDA approves magnetic device to relieve migraine pain - WorldNews

The End of Pain ‹ TERP
TRANSCRANIAL MAGNETIC STIMULATION DEVICE WITH BODY PROXIMITY SENSORS FOR THE TREATMENT OF MIGRAINE HEADACHES - ENEURA, INC.
He helps (and makes) millions | The Beacon Newspapers, Inc. 
The headache device, which received final approval from the Food and Drug Administration last year, is the brainchild of one of the great biomedical inventors of the past century, Robert E. Fischell M.S. ’54, Sc.D. (honorary) ’96.
FLEETING BURSTS OF ELECTROMAGNETISM known as pulses create electrical current in body tissues, blocking pain. That’s the concept behind the headache device, which he patented in 2002 along with his oldest son, David, and Canadian neurologist Dr. Adrian Upton.
UMD researchers helped develop prototypes of the device being brought to market by the Baltimore-based company eNeura. It is now delivering the device, called SpringTMS, to headache clinics around the nation in preparation for broader distribution in the next year.
How do electromagnetic pulses kill pain? Strangely enough, science can’t precisely answer that question because of our limited knowledge of the brain and nervous system. But Fischell’s theory is that the magnetic field scrambles communication between nerve cells. The result, he says, is that the signals received by the brain no longer register as pain.
Magnetic pulses have been used to treat depression, and implantable electrodes that direct electrical currents through the back for spinal pain work on a similar principle—although that requires expensive surgery and carries all of its associated risks, Fischell points out.
David Rosen, CEO of eNeura, predicts SpringTMS will revolutionize migraine treatment, but clinicians may at first be wary.



Fischell is planning a network of U.S. clinics where people suffering from bad backs, nerve pain from chemotherapy, achy arthritic joints and a host of other maladies can seek affordable, drug-free palliative care. Along with business partners—including UMD and the School of Medicine, each with a 3 percent cut—he’s set up a company called Zygood LLC to lay the groundwork for the clinics, which he hopes will operate nationwide and bring comfort to millions.

Previously/Related:

• First Rigorous Test Of Magnetic Stimulation Device Shows Promise For Short-Circuiting Migraines | Albert Einstein College of Medicine
• Migraine With Aura: Magnetic Stimulation Is A Promising Non-Drug Treatment Option - Medical News Today 
• Fischell, R.E., "The invention of the programmable implantable medication system," Engineering in Medicine and Biology Magazine, IEEE , vol.8, no.4, pp.65,66, Dec. 1989
  doi: 10.1109/51.45958
  Abstract: The author describes the genesis of his idea for a programmable implantable medication system and the problems encountered in going from idea to the first prototype. He discusses the funding, development, and marketing of his device. He provides some observations on the process of getting medical inventions into public use.<>
  keywords: {biomedical electronics;medical computing;patient treatment;device development;funding;marketing;medical inventions;programmable implantable medication system;public use;Batteries;Insulin;Laboratories;Manufacturing;Pacemakers;Physics;Prototypes;Pumps;Read only memory;Space technology},
  URL: http://ieeexplore.ieee.org/stamp/stamp.jsp?tp=&arnumber=45958&isnumber=1736
• Fischell, R.E., "The retrospectroscope-the invention of the rechargeable cardiac pacemaker: vignette #9," Engineering in Medicine and Biology Magazine, IEEE , vol.9, no.2, pp.77,78, Jun 1990
  doi: 10.1109/51.57877
  Abstract: The idea for a rechargeable cardiac pacemaker came to the author in the late 1960s after reading an advertisement stating that a company's batteries were so good they would last two years in a heart pacemaker. This meant that pacemaker patients would have to undergo surgery for their replacement frequently. Having worked on the development of hermetically sealed, nickel-cadmium batteries that could function for a decade or longer in an orbiting spacecraft, the author constructed the first prototype of a rechargeable cardiac pacemaker around 1968 to show cardiologists at Johns Hopkins Hospital that a pacemaker of indefinitely long life and much smaller size and weight could be built readily. The subsequent development and marketing of the device, which came on the market in 1973, is recounted
  keywords: {history;pacemakers;prosthetic power supplies;Johns Hopkins Hospital;batteries;heart pacemaker;rechargeable cardiac pacemaker;Batteries;Cities and towns;Hermetic seals;Hospitals;Laboratories;Pacemakers;Physics;Prototypes;Space technology;Space vehicles},
  URL: http://ieeexplore.ieee.org/stamp/stamp.jsp?tp=&arnumber=57877&isnumber=2100
• Saraiva Santos, N.; Sousa, S.C.P.; Crespo, P.; Cavaleiro Miranda, P.; Salvador, R.; Silvestre, J., "Shielding the magnetic field from a transcranial stimulator using aluminium and iron: Simulation and experimental results," Bioengineering (ENBENG), 2015 IEEE 4th Portuguese Meeting on , vol., no., pp.1,2, 26-28 Feb. 2015
  doi: 10.1109/ENBENG.2015.7088824
  Abstract: Repetitive transcranial magnetic stimulation (rTMS) is an up-and-coming, noninvasive technique that holds therapeutic promise in a range of neuropsychiatric and neurological diseases. In rTMS, a time-varying magnetic field induces an electric current in the brain. Since its introduction close to 30 years ago, numerous studies have widely recognised it in the research or treatment of several diseases (e.g. epilepsy, Parkinson's disease, stroke or neuropathic pain). rTMS treatments already occurring in the USA include psychiatric conditions like major depression (approved in 2008), and migraine (approved in 2013). Nevertheless, throughout several years it has been found that the stimulation of subcortical brain structures is inaccessible with standard rTMS equipment. Accessing such deep-brain regions may potentially result in the improvement of a variety of neuropsychiatric and neurological disorders. The design of TMS coils to stimulate deep brain targets is limited by the rapid attenuation of the electric field in depth. This is mainly due to the physical limiting effect arising from the presence of surface discontinuities. To the best of our knowledge the Hesed coil represents the state of the art of clinical deep-brain TMS. Nonetheless, there is no configuration able of producing an effective field at the very center of the brain. We have proposed a TMS system termed orthogonal configuration that is capable of reaching the very center of a spherical brain phantom (at 10-cm depth) with 58% strength in respect to the surface maximum. The high, external magnetic field of this configuration was designed so that it is incapable of inducing heart fibrillation in the patient by four orders of magnitude in respect to its threshold. Nevertheless, Comsol^® AC/DC simulations show that a system operator positioned sideways, 10 cm apart from the orthogonal configuration will experience an induced current density in his heart of 0.7 A/m² (heart fi- rillation threshold is 1 A/m²). Only 3.4 m away from the orthogonal configuration will a heart current density of 0.001 A/m² be achieved. In this work we focus on the shielding aspects necessary to install an orthogonal TMS system providing full safety to patient and any of its operators. For that, we have measured the TMS signal attenuation induced by an iron or aluminium slab of material positioned between a TMS coil and a current density sensor located inside a cylinder container filled with a saline solution (7 S/m, i.e. 5% ^w/v of NaCl in water). Simulations combined with experimental results show that a simple 25-mm-thick slab of aluminium surrounding five walls of the orthogonal TMS system (positioned 40 cm apart from its edges) is enough to achieve a current density in the heart of any operator inferior to 0.001 A/m², i.e. at least three orders of magnitude below fibrillation threshold. This allows us to conclude on the viability of implementing an R&D orthogonal TMS system in the near future.
  URL: http://ieeexplore.ieee.org/stamp/stamp.jsp?tp=&arnumber=7088824&isnumber=7088795
• Kortekaas, R.; van Belkum, S.M.; van Nierop, L.E.; Schoevers, R.A., "Weak field transcerebral pulsed electromagnetic fields in health care," Antennas and Propagation (EuCAP), 2014 8th European Conference on , vol., no., pp.1673,1676, 6-11 April 2014
  doi: 10.1109/EuCAP.2014.6902110
  Abstract: Neuropathic pain and major depressive disorder are two disorders that affect a large proportion of the population and that lead to vast losses of well being, productivity and money. Transcranial magnetic stimulation has been applied in both conditions, with encouraging results. Here we describe experimental treatment of these conditions with weak field transcerebral pulsed electromagnetic fields. Experimentel heat pain could be reduced with our stimulation, but this effect did not generalize to the capsaicin pain model in healthy volunteers. Studies in neuropathic pain patients have just finished data acquisition and studies in depressed patients are ongoing. We conclude that this type of weak field transcerebral pulsed electromagnetic stimulation deserves serious consideration in health care.
  keywords: {electromagnetic fields;health care;transcranial magnetic stimulation;capsaicin pain model;data acquisition;depressive disorder;health care;neuropathic pain;neuropathic pain patients;transcranial magnetic stimulation;weak field transcerebral pulsed electromagnetic fields;weak field transcerebral pulsed electromagnetic stimulation;Antennas;Conferences;Europe;extremely low frequency;measurement;propagation},
  URL: http://ieeexplore.ieee.org/stamp/stamp.jsp?tp=&arnumber=6902110&isnumber=6901672
• Sekino, M.; Suyama, M.; Dongmin Kim; Saitoh, Y., "A magnetic stimulator coil with high robustness to positioning error," General Assembly and Scientific Symposium (URSI GASS), 2014 XXXIth URSI , vol., no., pp.1,3, 16-23 Aug. 2014
  doi: 10.1109/URSIGASS.2014.6930094
  Abstract: Transcranial magnetic stimulation (TMS) is effective for treatment of neurological diseases such as neuropathic pain. We are newly developing magnetic stimulators for use at patient's home for realizing daily treatment. One of the technical challenges is a system for positioning the stimulator coil. In this study, we proposed a coil design which gives a high robustness to positioning error. We numerically evaluated the characteristics of the coil when changing the width, depth, height, and the number of turns of the coil. The results showed that the mostly influencing parameter on the broadening of the eddy current was the width of the coil, and the vertical length was influential on the current density. We found the proposed coil induces eddy currents in a wider range than conventional figure-eight coils.
  URL: http://ieeexplore.ieee.org/stamp/stamp.jsp?tp=&arnumber=6930094&isnumber=6928981 
• Saitoh, Y.; Maruo, T.; Yokoe, M.; Matsuzaki, T.; Sekino, M., "Electrical or repetitive transcranial magnetic stimulation of primary motor cortex for intractable neuropathic pain," Engineering in Medicine and Biology Society (EMBC), 2013 35th Annual International Conference of the IEEE , vol., no., pp.6163,6166, 3-7 July 2013
  doi: 10.1109/EMBC.2013.6610960
  Abstract: Objective: To assess the pain-relieving effects of motor cortex electrical stimulation (MCS) and the predictive factors retrospectively. Methods: Thirty-four patients with intractable neuropathic pain underwent MCS; 19 patients had cerebral lesions, and 15 had non-cerebral lesions. In selected 12 patients, test electrodes were implanted within the central sulcus and on the precentral gyrus. Twelve patients received both MCS and repetitive transcranial magnetic stimulation (rTMS) of the primary motor cortex. Results: Pain reduction of >50% was observed in 12 of 32 (36%) patients with >12 months follow-ups (2 patients were excluded because of short follow-up). In 10 of the 12 patients who received test electrodes within the central sulcus and on the precentral gyrus, the optimal stimulation was MCS within the central sulcus. In 4 of these (40%) patients, positive effects were maintained at follow-ups. The pain reduction of rTMS significantly correlated with that of MCS during test stimulation. Conclusions: The test stimulation within the central sulcus was more effective than that of the precentral gyrus. In the selected patients, chronic stimulation within the central sulcus did not significantly improve long-term results. Repeated rTMS seems to be same effective as MCS.
  URL: http://ieeexplore.ieee.org/stamp/stamp.jsp?tp=&arnumber=6610960&isnumber=6609410 
• Yasumuro, Y.; Ebisuwaki, R.; Fuyuki, M.; Matsuzaki, T.; Saitoh, Y., "Coil positioning system for repetitive transcranial magnetic stimulation treatment by ToF camera ego-motion," Engineering in Medicine and Biology Society (EMBC), 2013 35th Annual International Conference of the IEEE , vol., no., pp.3586,3589, 3-7 July 2013
  doi: 10.1109/EMBC.2013.6610318
  Abstract: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive method for treating various neurological and psychiatric disorders. With the growing demands of neuropathic pain patients and their increasing numbers, rTMS treatment tools are becoming more necessary. rTMS uses electromagnetic induction to induce weak electric currents by rapidly changing the magnetic field. Targeting the electric current to a specific part of the brain is one treatment for pain relief. This paper focuses on treatment for neuropathic pain caused by a lesion or disease of the central or peripheral nervous system, including stroke, trauma, or surgery. However, the current style of rTMS treatment is still developing and is so technically specialized that only a limited number of hospitals and only a handful of specialists can provide this therapy. The existing rTMS systems use an optical markerbased 3D sensing technique that positions the stimulation coil to target the small region of interest in the brain through coregistration with pre-scanned MRI data. This system requires the patient to be immobilized on a bed. The optical markers for 3D sensing are placed on the patient's head to maintain accurate positioning. We propose a constraints-free, markerless rTMS system, which employs ego-motion, a computation technique to estimate relative 3D motion of a camera to what the camera sees. We use a ToF sensor as a camera, which is capble of capturing shape information from a single viewpoint instantly. The markerless target spot is based on the shape features of the patient's face. This paper shows the process of a prototype system and its potential for achieving an easy-to-handle system framework.
  URL: http://ieeexplore.ieee.org/stamp/stamp.jsp?tp=&arnumber=6610318&isnumber=6609410
• Yasumuro, Y.; Hosomi, K.; Saitoh, Y.; Matsuzaki, T., "Uncertainty assessment of target localization for rTMS treatment," Complex Medical Engineering (CME), 2012 ICME International Conference on , vol., no., pp.784,787, 1-4 July 2012
  doi: 10.1109/ICCME.2012.6275590
  Abstract: Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive method for treating various neurological and psychiatric disorders. This paper focuses on a technical aspect of this treatment method for neuropathic pain that can be caused by a lesion or disease of the central or peripheral nervous system, including stroke, trauma or surgical operation. rTMS uses electromagnetic induction to induce weak electric currents by rapidly changing the magnetic field. Targeting a specific part of the brain to locate the magnetic field works as a treatment for pain relief. This is the reason why the current style of rTMS treatment is still developing and is so technically specialized that only a limited number of hospitals and only a handful of specialists can provide this therapy. The existing systems of rTMS are based on an optical maker-based 3-dimensional (3D) sensing technique for positioning the stimulation coil to target the small spot in the region of interest in the brain, and for referring pre-scanned MRI data to check the target position. Furthermore, the existing systems require the patient to be fixed on a bed in which optical markers for 3D sensing are placed during the treatment to maintain positioning precision. With the growing demands of neuropathic pain patients and their increasing numbers, new approaches and systems to achieve more supportive and easy-to-handle navigation have been proposed lately for rTMS treatment. This paper proposes a quantitative index for localization precision, considering an uncertainty measure. Uncertainty is technically defined as a parameter, associated with the result of a measurement that characterizes the dispersion of the values that could reasonably be attributed to the measurement. This paper shows a detailed example of the uncertainty derivation for rTMS treatment, based on trial tasks for searching the spots on the brain that cause muscle twitch.
  URL: http://ieeexplore.ieee.org/stamp/stamp.jsp?tp=&arnumber=6275590&isnumber=6275588