New Indications for Brainsway – Deep Transcranial Magnetic Stimulation – PART 1
1. Pain syndromes:
In the United States, chronic pain and fatigue are extremely prevalent in the general population,[60, 73, 74]especially among women and persons of lower socioeconomic status. The prevalence of regional pain is 20%; widespread pain, 11%; and chronic fatigue, approximately 20%. See the Israeli review by Treister R et al1
1.1. FIBROMYALGIA:
Fibromyalgiais a disorder of chronic, widespread pain and tenderness. It typically presents in young or middle-aged women but can affect patients of either sex and at any age.
Fibromyalgia, as defined by the 1990 American College of Rheumatology (ACR) classification criteria,[10]has a prevalence of 3-5% in females and 0.5-1.6% in males. Because the ACR criteria are insensitive, the actual prevalence offibromyalgiais higher, particularly in men.
Fibromyalgiais the second most common disorder that rheumatologists encounter, seen in 15% of evaluated patients. Approximately 8% of patients cared for in primary care clinics havefibromyalgia.
The annual economic burden offibromyalgiain 2005 was $10,199 per patient per year, nearly double that of matched controls.[75]It has been estimated that overall,fibromyalgiacosts the US economy over $9 billion annually.[76]
TMS:
Maestú C,Blanco M,Nevado A,Romero J,Rodríguez-Rubio P,Galindo J,Bautista Lorite J,de Las Morenas F,Fernández-Argüelles P. Reduction of pain thresholds infibromyalgiaafter very low-intensitymagneticstimulation: A double-blinded, randomized placebo-controlled clinical trial. Pain Res Manag.2013 Nov-Dec;18(6):e101-6.
Tzabazis A,Aparici CM,Rowbotham MC,Schneider MB,Etkin A,Yeomans DC.Mol Shapedmagneticfield pulses by multi-coil repetitivetranscranial magnetic stimulation(rTMS) differentially modulate anterior cingulate cortex responses and pain in volunteers andfibromyalgiapatients. Pain.2013 Jul 2;9(1):33. [Epub ahead of print]
Lee SJ,Kim DY,Chun MH,Kim YG. The effect of repetitivetranscranial magnetic stimulationonfibromyalgia: a randomized sham-controlled trial with 1-mo follow-up. Am J Phys Med Rehabil.2012 Dec;91(12):1077-85. doi: 10.1097/PHM.0b013e3182745a04.
Short EB,Borckardt JJ,Anderson BS,Frohman H,Beam W,Reeves ST,George MS. Ten sessions of adjunctive left prefrontal rTMS significantly reducesfibromyalgiapain: a randomized, controlled pilot study. Pain.2011 Nov;152(11):2477-84. doi: 10.1016/j.pain.2011.05.033. Epub 2011 Jul 20.
Mhalla A,Baudic S,Ciampi de Andrade D,Gautron M,Perrot S,Teixeira MJ,Attal N,Bouhassira D. Long-term maintenance of the analgesic effects oftranscranial magnetic stimulationinfibromyalgia. Pain.2011 Jul;152(7):1478-85. doi: 10.1016/j.pain.2011.01.034. Epub 2011 Mar 11.
Carretero B,Martín MJ,Juan A,Pradana ML,Martín B,Carral M,Jimeno T,Pareja A,Montoya P,Aguirre I,Salva J,Roca M,Gili M,Garcia-Toro M. Low-frequencytranscranial magnetic stimulationin patients withfibromyalgiaand major depression. Pain Med.2009 May-Jun;10(4):748-53. doi: 10.1111/j.1526-4637.2009.00625.x. Epub 2009 May 4.
Sampson SM,Rome JD,Rummans TA. Slow-frequency rTMS reducesfibromyalgiapain. Pain Med.2006 Mar-Apr;7(2):115-8.
1.2. CHRONIC PAIN SYNDROME
Chronicpain syndrome (CPS) is a common problem that presents a major challenge to health-care providers because of its complex natural history, unclear etiology, and poor response to therapy. CPS is a poorly defined condition. Most authors consider ongoing pain lasting longer than 6 months as diagnostic, and others have used 3 months as the minimum criterion. Inchronicpain, the duration parameter is used arbitrarily. Some authors suggest that any pain that persists longer than the reasonably expected healing time for the involved tissues should be consideredchronicpain. CPS is a constellation ofsyndromes that usually do not respond to the medical model of care.
Approximately 35% of Americans have some element ofchronicpain,and approximately 50 million Americans are disabled partially or totally due tochronicpain. Major effects on the patient's life are depressed mood, fatigue, reduced activity, excessive use of drugs, dependent behavior, disability, and in some cases suicidal thoughts/actions. Parentalchronicpainincreases the risk of internalizing symptoms, including anxiety and depression in adolescents.77
TMS:
Lefaucheur JP. Is rTMS a therapeutic option in chronic pain syndrome? Insights from the treatment offibromyalgia. Pain.2011 Jul;152(7):1447-8. doi: 10.1016/j.pain.2011.03.004. Epub 2011 Mar 29.
Ahdab R,Ayache SS,Brugières P,Goujon C,Lefaucheur JP.
Comparison of "standard" and "navigated" procedures of TMS coil positioning over motor, premotor and prefrontal targets in patients with chronic pain and depression. Neurophysiol Clin.2010 Mar;40(1):27-36. doi: 10.1016/j.neucli.2010.01.001. Epub 2010 Jan 22.
1.3. NEUROPATHIC PAIN (TRIGIMINAL NEURALGIA, DIABETIC NEUROPATHIC PAIN)
Neuropathicpain(NP) develops as a consequence of a lesion or disease affecting the somatosensory pathways in the peripheral or central nervous system, and occurs in many neurological diseases (eg, peripheral neuropathy, radiculopathy, spinal cord injury, stroke and multiple sclerosis). It affects 6%–8% of the general population and its impact on quality of life, mood and sleep exceeds the burden of its causative pathology. A peculiar feature of NP is the coexistence of negative and positive symptoms and signs, reflecting loss-of-function and gain-of-function of the somatosensory system, respectively. NP has long been considered a difficult clinical issue because of the lack of a diagnostic gold standard and the unsatisfactory response to treatment 78.
TMS:
Saitoh Y,Maruo T,Yokoe M,Matsuzaki T,Sekino M. Electrical or repetitivetranscranial magnetic stimulationof primary motor cortex for intractableneuropathic pain. Conf Proc IEEE Eng Med Biol Soc.2013;2013:6163-6. Doi: 10.1109/EMBC.2013.6610960.
Hosomi K,Shimokawa T,Ikoma K,Nakamura Y,Sugiyama K,Ugawa Y,Uozumi T,Yamamoto T,Saitoh Y. Daily repetitivetranscranial magnetic stimulationof primary motor cortex for neuropathic pain: a randomized, multicenter, double-blind, crossover, sham-controlled trial. Pain.2013 Jul;154(7):1065-72. Doi: 10.1016/j.pain.2013.03.016. Epub 2013 Mar 15.
Lefaucheur JP,Ayache SS,Sorel M,Farhat WH,Zouari HG,Ciampi de Andrade D,Ahdab R,Ménard-Lefaucheur I,Brugières P,Goujon C. Analgesic effects of repetitivetranscranial magnetic stimulationof the motor cortex in neuropathic pain: influence of theta burststimulationpriming. Eur J Pain.2012 Nov;16(10):1403-13. Doi: 10.1002/j.1532-2149.2012.00150.x. Epub 2012 Apr 16.
Sampson SM,Kung S,McAlpine DE,Sandroni P. The use of slow-frequency prefrontal repetitivetranscranial magnetic stimulationin refractory neuropathic pain. J ECT.2011 Mar;27(1):33-7. Doi: 10.1097/YCT.0b013e31820c6270.
Lefaucheur JP,Jarry G,Drouot X,Ménard-Lefaucheur I,Keravel Y,Nguyen JP.
Motor cortex Rtms reduces acutepainprovoked by laserstimulationin patients with chronicneuropathic pain. Clin Neurophysiol.2010 Jun;121(6):895-901. Doi: 10.1016/j.clinph.2009.12.028. Epub 2010 Jan 25.
Borckardt JJ,Smith AR,Reeves ST,Madan A,Shelley N,Branham R,Nahas Z,George MS. A pilot study investigating the effects of fast left prefrontal Rtms on chronicneuropathic pain. PainMed.2009 Jul-Aug;10(5):840-9. Doi: 10.1111/j.1526-4637.2009.00657.x. Epub 2009 Jul 6.
André-Obadia N,Mertens P,Gueguen A,Peyron R,Garcia-Larrea L.
Pain relief by Rtms: differential effect of current flow but no specific action on pain subtypes. Neurology.2008 Sep 9;71(11):833-40. Doi: 10.1212/01.wnl.0000325481.61471.f0.
Lefaucheur JP,Drouot X,Ménard-Lefaucheur I,Keravel Y,Nguyen JP.
Motor cortex Rtms in chronic neuropathic pain: pain relief is associated with thermal sensory perception improvement. J Neurol Neurosurg Psychiatry.2008 Sep;79(9):1044-9. Doi: 10.1136/jnnp.2007.135327. Epub 2008 Jan 25.
Khedr EM,Kotb H,Kamel NF,Ahmed MA,Sadek R,Rothwell JC.
Longlasting antalgic effects of daily sessions of repetitivetranscranial magnetic stimulationin central and peripheral neuropathic pain. J Neurol Neurosurg Psychiatry.2005 Jun;76(6):833-8.
Lefaucheur JP,Drouot X,Ménard-Lefaucheur I,Nguyen JP.
Neuropathic paincontrolled for more than a year by monthly sessions of repetitivetranscranial magnetic stimulationof the motor cortex. Neurophysiol Clin.2004 Apr;34(2):91-5.
Lefaucheur JP,Drouot X,Menard-Lefaucheur I,Zerah F,Bendib B,Cesaro P,Keravel Y,Nguyen JP.Neurogenicpainrelief by repetitive Transcranial Magnetic Cortical Stimulation depends on the origin and the site ofpain. J Neurol Neurosurg Psychiatry.2004 Apr;75(4):612-6.
1.4. PHANTOM PAIN:
Aphantomlimbis the sensation that anamputatedor missinglimb(even an organ, like the appendix) is still attached to thebodyand is moving appropriately with other body parts.[79][80][81]Approximately 60 to 80% of individuals with an amputation experience phantom sensations in their amputatedlimb, and the majority of the sensations are painful.[82]Phantom sensations may also occur after the removal of body parts other than thelimbs, e.g. after amputation of the breast, extraction of a tooth (phantomtoothpain) or removal of an eye (phantomeye syndrome). The missinglimboften feels shorter and may feel as if it is in a distorted andpainful position. Occasionally, thepaincan be made worse bystress,anxiety, and weather changes. Phantomlimbpainis usually intermittent. The frequency and intensity of attacks usually declines with time.[83]
TMS:
Ahmed MA,Mohamed SA,Sayed D. Long-term antalgic effects of repetitivetranscranial magnetic stimulationof motor cortex and serum beta-endorphin in patients with phantom pain. Neurol Res.2011 Nov;33(9):953-8. doi: 10.1179/1743132811Y.0000000045.
Di Rollo A,Pallanti S. Phantom limb pain: low frequency repetitivetranscranial magnetic stimulationin unaffected hemisphere. Case Rep Med.2011;2011:130751. doi: 10.1155/2011/130751. Epub 2011 May 11.
Clin Neurophysiol.2003 Aug;114(8):1521-30. Repetitivetranscranial magnetic stimulationof the parietal cortex transiently ameliorates phantom limbpain-likesyndrome.
Töpper R,Foltys H,Meister IG,Sparing R,Boroojerdi B.
1.5. POST SPINAL CORD INJURY PAIN AND DISABILITY:
Spinalcord injury (SCI) is an insult to thespinalcord resulting in a change, either temporary or permanent, in the cord’s normal motor, sensory, or autonomic function. Patients withspinalcordinjuryusually have permanent and often devastating neurologic deficits and disability.
The incidence ofspinalcordinjuryin the United States is approximately 40 cases per million population, or about 12,000 patients, per year based on data in the NationalSpinalCordInjurydatabase.[84]However, this estimate is based on older data from the 1990s as there has not been any new overall incidence studies completed.[84]Estimates from various studies suggest that the number of people in the United States alive in 2010 withspinalcordinjurywas about 265,000 persons (range, 232,000-316,000).[84]
Studies have found that patients withspinalcordinjurywho suffer from pain have less life satisfaction than do patients in whom pain is well controlled; this may also affect the patients' general outlook on life.[85, 86]
TMS:
Pain:
Jetté F,Côté I,Meziane HB,Mercier C. Effect of single-session repetitivetranscranial magnetic stimulationapplied over the hand versus leg motor area on pain after spinal cord injury. Neurorehabil Neural Repair.2013 Sep;27(7):636-43. doi: 10.1177/1545968313484810. Epub 2013 Apr 11.
Kim JY,Choi GS,Cho YW,Cho H,Hwang SJ,Ahn SH. Attenuation of spinal cord injury-induced astroglial and microglial activation by repetitivetranscranial magnetic stimulationin rats. J Korean Med Sci.2013 Feb;28(2):295-9. doi: 10.3346/jkms.2013.28.2.295. Epub 2013 Jan 29.
Kang BS,Shin HI,Bang MS. Effect of repetitivetranscranial magnetic stimulationover the hand motor cortical area on central pain afterspinal cord injury. Arch Phys Med Rehabil.2009 Oct;90(10):1766-71. doi: 10.1016/j.apmr.2009.04.008.
Defrin R,Grunhaus L,Zamir D,Zeilig G. The effect of a series of repetitivetranscranialmagneticstimulations of the motor cortex on central pain afterspinal cord injury. Arch Phys Med Rehabil.2007 Dec;88(12):1574-80.
Disability:
Kumru H,Benito J,Murillo N,Valls-Sole J,Valles M,Lopez-Blazquez R,Costa U,Tormos JM,Pascual-Leone A,Vidal J. Effects of high-frequency repetitivetranscranial magnetic stimulationon motor and gait improvement in incomplete spinal cord injury patients. Neurorehabil Neural Repair.2013 Jun;27(5):421-9. doi: 10.1177/1545968312471901. Epub 2013 Jan 15.
Benito J,Kumru H,Murillo N,Costa U,Medina J,Tormos JM,Pascual-Leone A,Vidal J. Motor and gait improvement in patients with incomplete spinal cord injury induced by high-frequency repetitivetranscranial magnetic stimulation. Top Spinal Cord Inj Rehabil.2012 Spring;18(2):106-12. doi: 10.1310/sci1802-106.
Kuppuswamy A,Balasubramaniam AV,Maksimovic R,Mathias CJ,Gall A,Craggs MD,Ellaway PH. Action of 5 Hz repetitivetranscranial magnetic stimulationon sensory, motor and autonomic function in humanspinal cord injury. Clin Neurophysiol.2011 Dec;122(12):2452-61. doi: 10.1016/j.clinph.2011.04.022. Epub 2011 May 19.
Kumru H,Murillo N,Samso JV,Valls-Sole J,Edwards D,Pelayo R,Valero-Cabre A,Tormos JM,Pascual-Leone A. Reduction of spasticity with repetitivetranscranial magnetic stimulationin patients withspinal cord injury. Neurorehabil Neural Repair.2010 Jun;24(5):435-41. doi: 10.1177/1545968309356095. Epub 2010 Jan 6.
Benito Penalva J,Opisso E,Medina J,Corrons M,Kumru H,Vidal J,Valls-Solé J.
H reflex modulation bytranscranial magnetic stimulationinspinal cord injurysubjects after gait training with electromechanical systems. SpinalCord.2010 May;48(5):400-6. doi: 10.1038/sc.2009.151. Epub 2009 Nov 24.
Belci M,Catley M,Husain M,Frankel HL,Davey NJ. Magnetic Brain stimulationcan improve clinical outcome in incomplete spinal cord injured patients. SpinalCord.2004 Jul;42(7):417-9.
Poirrier AL,Nyssen Y,Scholtes F,Multon S,Rinkin C,Weber G,Bouhy D,Brook G,Franzen R,Schoenen J. Repetitivetranscranial magnetic stimulationimproves open field locomotor recovery after low but not high thoracicspinalcordcompression-injuryin adult rats. J Neurosci Res.2004 Jan 15;75(2):253-61.
1.6. COMPLEX REGIONAL PAIN SYNDROME (CRPS):
Complexregionalpainsyndrome(CRPS), formerlyreflex sympathetic dystrophy (RSD) or "causalgia",reflex neurovascular dystrophy(RND), oramplified musculoskeletalpainsyndrome(AMPS), is a chronic systemic disease characterized by severepain, swelling, and changes in the skin. CRPS is expected to worsen over time.It often initially affects an arm or a leg and often spreads throughout the body; 92% of patients state that they have experienced a spread, and 35% of patients report symptoms in their whole body.Recent evidence has led to the conclusion thatComplexRegionalPainSyndromeis a multifactorial disorder with clinical features ofneurogenic inflammation, nociceptive sensitisation (which causes extreme sensitivity orallodynia),vasomotordysfunction, and maladaptiveneuroplasticity, generated by an aberrant response to tissue injury.Treatment is complicated, involving drugs, physical therapy, psychologic treatments, andneuromodulationand usually unsatisfactory, especially if begun late.
A population-based study by Sandroni et al showed an incidence of approximately 5.5 per 100,000 person-years at risk and a prevalence of about 21 per 100,000 for CRPS type I.[87]The same study showed an incidence of 0.8 per 100,000 and a prevalence of about 4 per 100,000 for CRPS type II.[87]Therefore, the incidence of CRPS type I is higher than that of CRPS type II.[87]The reported incidence of CRPS type I is 1-2% after various fractures[88], while that of CRPS type II approximates 1-5% after peripheral nerve injury[88, 89]. The incidence of CRPS is 12% after abrain injury[90]and 5% after amyocardial infarction[91].
TMS:
Picarelli H,Teixeira MJ,de Andrade DC,Myczkowski ML,Luvisotto TB,Yeng LT,Fonoff ET,Pridmore S,Marcolin MA. Repetitivetranscranial magnetic stimulationis efficacious as an add-on to pharmacological therapy in complex regional pain syndrome (CRPS) type I. J Pain.2010 Nov;11(11):1203-10. doi: 10.1016/j.jpain.2010.02.006. Epub 2010 Apr 28.
Pleger B,Janssen F,Schwenkreis P,Völker B,Maier C,Tegenthoff M. Repetitivetranscranial magnetic stimulationof the motor cortex attenuates pain perception in complex regional pain syndrome type I. Neurosci Lett.2004 Feb 12;356(2):87-90.
1.7. MIGRAINE: (May consider research on variants like Abdominal migraine, Cyclic vomiting et)
Migraineis a complex disorder characterized by recurrent episodes of headache, most often unilateral and in some cases associated with visual or sensory symptoms—collectively known as an aura—that arise most often before the head pain but that may occur during or afterward.Migraineis most common in women and has a strong genetic component.
Migraineis a disorder affecting more than 13% of the general population in the United States. In the United States, more than 30 million people have 1 or moremigraine headaches per year. This corresponds to approximately 18% of females and 6% of males.[92]Migraineaccounts for 64% of severe headaches in females and 43% of severe headaches in males.
The economic cost resulting frommigraine-related loss of productive time in the US workforce is more than $13 billion per year, most of which is in the form of reduced work productivity.
TMS:
Neurol Res.2012 Jul;34(6):547-51. doi: 10.1179/1743132812Y.0000000045. Epub 2012 Jun 20.
High frequency repetitivetranscranial magnetic stimulation(rTMS) is effective inmigraineprophylaxis: an open labeled study.