Clinical trial NCT02758496: A Chart Review to Evaluate the Safety and Efficacy of MeRT on Subjects With ASD
Official title: A Chart Review to Evaluate the Safety and Efficacy of Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) on Subjects With Autism Spectrum Disorder (ASD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autistic Disorder
Keywords: Autism, chart review, transcranial magnetic stimulation (TMS)
Lead sponsor: Wave Neuroscience
Sponsor class: INDUSTRY
First posted: 2016-05-02
Enrollment: 141
Sex: ALL
Minimum age (years): 2
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Two hundred (200) male and female subjects of any ethnic background between the ages of 2-20 years old seen at the Brain Treatment Center between 2010 and 2015. Twenty (20) male and female subjects of any ethnic background between the ages of 2-20 years old with neurotypical EEGs will be selected for comparison to the ASD group.

Brief summary: The purpose of this study is to evaluate the safety and efficacy of Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) on subjects with Autism Spectrum Disorder (ASD).

Detailed description: This is a retrospective chart review of 200 consecutive charts of subjects ages 2-20 years old seen at the Brain Treatment Center between 2010 and 2015. The review is designed to evaluate the safety and efficacy of Magnetic Electroencephalogram/Electrocardiogram(EEG/ECG)-Guided Resonance Therapy (MeRT) on subjects with Autism Spectrum Disorder (ASD).

Eligibility criteria: Inclusion Criteria:

1. Must have completed a baseline EEG at the Brain Treatment Center (BTC)
2. Age between 2 and 20 years old at initial visit
3. Must have a diagnosis of ASD according to the prevailing standard at that time (i.e., Diagnostic and Statistical Manual-IV (DSM-IV)) (ASD Group only)
4. Must have received Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) for more than (5) sessions (ASD Group only)

   Exclusion Criteria:
5. Clinically significant abnormality or clinically significant unstable medical condition during treatment that in the Investigator's judgment may have may limited interpretation of the results.

Primary outcomes:
measure: Childhood Autism Rating Scale (CARS)
timeFrame: Baseline through study completion, an average of 36 months
Secondary outcomes:
measure: Electrophysiological
timeFrame: Baseline through study completion, an average of 36 months
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Brain Treatment Center
state: California
Study officials:
affiliation: Brain Treatment Center
name: Keun-Young Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krakowiak P, Walker CK, Bremer AA, Baker AS, Ozonoff S, Hansen RL, Hertz-Picciotto I. Maternal metabolic conditions and risk for autism and other neurodevelopmental disorders. Pediatrics. 2012 May;129(5):e1121-8. doi: 10.1542/peds.2011-2583. Epub 2012 Apr 9.
citation: Betancur C, Sakurai T, Buxbaum JD. The emerging role of synaptic cell-adhesion pathways in the pathogenesis of autism spectrum disorders. Trends Neurosci. 2009 Jul;32(7):402-12. doi: 10.1016/j.tins.2009.04.003. Epub 2009 Jun 21.
citation: Crespi B, Stead P, Elliot M. Evolution in health and medicine Sackler colloquium: Comparative genomics of autism and schizophrenia. Proc Natl Acad Sci U S A. 2010 Jan 26;107 Suppl 1(Suppl 1):1736-41. doi: 10.1073/pnas.0906080106. Epub 2009 Dec 1.
citation: Stigler KA, S.T., Posey DJ, McDougle CJ, Autism and immune factors: a comprehensive review. Res Autism Spectr Disord, 3(4): p. 840-860.2009.
citation: Sudhof TC. Neuroligins and neurexins link synaptic function to cognitive disease. Nature. 2008 Oct 16;455(7215):903-11. doi: 10.1038/nature07456.
citation: Levy SE, Mandell DS, Schultz RT. Autism. Lancet. 2009 Nov 7;374(9701):1627-38. doi: 10.1016/S0140-6736(09)61376-3. Epub 2009 Oct 12.
citation: Just MA, Cherkassky VL, Keller TA, Kana RK, Minshew NJ. Functional and anatomical cortical underconnectivity in autism: evidence from an FMRI study of an executive function task and corpus callosum morphometry. Cereb Cortex. 2007 Apr;17(4):951-61. doi: 10.1093/cercor/bhl006. Epub 2006 Jun 13.
citation: Buie T, Campbell DB, Fuchs GJ 3rd, Furuta GT, Levy J, Vandewater J, Whitaker AH, Atkins D, Bauman ML, Beaudet AL, Carr EG, Gershon MD, Hyman SL, Jirapinyo P, Jyonouchi H, Kooros K, Kushak R, Levitt P, Levy SE, Lewis JD, Murray KF, Natowicz MR, Sabra A, Wershil BK, Weston SC, Zeltzer L, Winter H. Evaluation, diagnosis, and treatment of gastrointestinal disorders in individuals with ASDs: a consensus report. Pediatrics. 2010 Jan;125 Suppl 1:S1-18. doi: 10.1542/peds.2009-1878C.
citation: Happe F, Ronald A. The 'fractionable autism triad': a review of evidence from behavioural, genetic, cognitive and neural research. Neuropsychol Rev. 2008 Dec;18(4):287-304. doi: 10.1007/s11065-008-9076-8. Epub 2008 Oct 28.
citation: Amaral DG, Schumann CM, Nordahl CW. Neuroanatomy of autism. Trends Neurosci. 2008 Mar;31(3):137-45. doi: 10.1016/j.tins.2007.12.005. Epub 2008 Feb 6.
citation: Kujirai T, Caramia MD, Rothwell JC, Day BL, Thompson PD, Ferbert A, Wroe S, Asselman P, Marsden CD. Corticocortical inhibition in human motor cortex. J Physiol. 1993 Nov;471:501-19. doi: 10.1113/jphysiol.1993.sp019912.
citation: Billstedt E, Gillberg IC, Gillberg C. Autism after adolescence: population-based 13- to 22-year follow-up study of 120 individuals with autism diagnosed in childhood. J Autism Dev Disord. 2005 Jun;35(3):351-60. doi: 10.1007/s10803-005-3302-5.
citation: Langstrom N, Grann M, Ruchkin V, Sjostedt G, Fazel S. Risk factors for violent offending in autism spectrum disorder: a national study of hospitalized individuals. J Interpers Violence. 2009 Aug;24(8):1358-70. doi: 10.1177/0886260508322195. Epub 2008 Aug 13.
citation: Posey DJ, Stigler KA, Erickson CA, McDougle CJ. Antipsychotics in the treatment of autism. J Clin Invest. 2008 Jan;118(1):6-14. doi: 10.1172/JCI32483.
citation: Happe F, Ronald A, Plomin R. Time to give up on a single explanation for autism. Nat Neurosci. 2006 Oct;9(10):1218-20. doi: 10.1038/nn1770.
citation: Larsson HJ, Eaton WW, Madsen KM, Vestergaard M, Olesen AV, Agerbo E, Schendel D, Thorsen P, Mortensen PB. Risk factors for autism: perinatal factors, parental psychiatric history, and socioeconomic status. Am J Epidemiol. 2005 May 15;161(10):916-25; discussion 926-8. doi: 10.1093/aje/kwi123.
citation: Geschwind DH. Autism: many genes, common pathways? Cell. 2008 Oct 31;135(3):391-5. doi: 10.1016/j.cell.2008.10.016.
citation: Hultman CM, Sparen P, Cnattingius S. Perinatal risk factors for infantile autism. Epidemiology. 2002 Jul;13(4):417-23. doi: 10.1097/00001648-200207000-00009.
citation: Cheslack-Postava K, Liu K, Bearman PS. Closely spaced pregnancies are associated with increased odds of autism in California sibling births. Pediatrics. 2011 Feb;127(2):246-53. doi: 10.1542/peds.2010-2371. Epub 2011 Jan 10.
citation: Sebat J, Lakshmi B, Malhotra D, Troge J, Lese-Martin C, Walsh T, Yamrom B, Yoon S, Krasnitz A, Kendall J, Leotta A, Pai D, Zhang R, Lee YH, Hicks J, Spence SJ, Lee AT, Puura K, Lehtimaki T, Ledbetter D, Gregersen PK, Bregman J, Sutcliffe JS, Jobanputra V, Chung W, Warburton D, King MC, Skuse D, Geschwind DH, Gilliam TC, Ye K, Wigler M. Strong association of de novo copy number mutations with autism. Science. 2007 Apr 20;316(5823):445-9. doi: 10.1126/science.1138659. Epub 2007 Mar 15.
citation: Marshall CR, Noor A, Vincent JB, Lionel AC, Feuk L, Skaug J, Shago M, Moessner R, Pinto D, Ren Y, Thiruvahindrapduram B, Fiebig A, Schreiber S, Friedman J, Ketelaars CE, Vos YJ, Ficicioglu C, Kirkpatrick S, Nicolson R, Sloman L, Summers A, Gibbons CA, Teebi A, Chitayat D, Weksberg R, Thompson A, Vardy C, Crosbie V, Luscombe S, Baatjes R, Zwaigenbaum L, Roberts W, Fernandez B, Szatmari P, Scherer SW. Structural variation of chromosomes in autism spectrum disorder. Am J Hum Genet. 2008 Feb;82(2):477-88. doi: 10.1016/j.ajhg.2007.12.009. Epub 2008 Jan 17.
citation: Weiss LA, Shen Y, Korn JM, Arking DE, Miller DT, Fossdal R, Saemundsen E, Stefansson H, Ferreira MA, Green T, Platt OS, Ruderfer DM, Walsh CA, Altshuler D, Chakravarti A, Tanzi RE, Stefansson K, Santangelo SL, Gusella JF, Sklar P, Wu BL, Daly MJ; Autism Consortium. Association between microdeletion and microduplication at 16p11.2 and autism. N Engl J Med. 2008 Feb 14;358(7):667-75. doi: 10.1056/NEJMoa075974. Epub 2008 Jan 9.
citation: Ronald A, Happe F, Bolton P, Butcher LM, Price TS, Wheelwright S, Baron-Cohen S, Plomin R. Genetic heterogeneity between the three components of the autism spectrum: a twin study. J Am Acad Child Adolesc Psychiatry. 2006 Jun;45(6):691-699. doi: 10.1097/01.chi.0000215325.13058.9d.
citation: Rogers SJ. What are infant siblings teaching us about autism in infancy? Autism Res. 2009 Jun;2(3):125-37. doi: 10.1002/aur.81.
citation: Filipek PA, Accardo PJ, Baranek GT, Cook EH Jr, Dawson G, Gordon B, Gravel JS, Johnson CP, Kallen RJ, Levy SE, Minshew NJ, Ozonoff S, Prizant BM, Rapin I, Rogers SJ, Stone WL, Teplin S, Tuchman RF, Volkmar FR. The screening and diagnosis of autistic spectrum disorders. J Autism Dev Disord. 1999 Dec;29(6):439-84. doi: 10.1023/a:1021943802493.
citation: Beaudet AL. Autism: highly heritable but not inherited. Nat Med. 2007 May;13(5):534-6. doi: 10.1038/nm0507-534. No abstract available.
citation: Schmitz C, Rezaie P. The neuropathology of autism: where do we stand? Neuropathol Appl Neurobiol. 2008 Feb;34(1):4-11. doi: 10.1111/j.1365-2990.2007.00872.x. Epub 2007 Oct 26.
citation: Piven J, Palmer P, Jacobi D, Childress D, Arndt S. Broader autism phenotype: evidence from a family history study of multiple-incidence autism families. Am J Psychiatry. 1997 Feb;154(2):185-90. doi: 10.1176/ajp.154.2.185.
citation: Weissman JR, Kelley RI, Bauman ML, Cohen BH, Murray KF, Mitchell RL, Kern RL, Natowicz MR. Mitochondrial disease in autism spectrum disorder patients: a cohort analysis. PLoS One. 2008;3(11):e3815. doi: 10.1371/journal.pone.0003815. Epub 2008 Nov 26.
citation: Frye RE, Melnyk S, Macfabe DF. Unique acyl-carnitine profiles are potential biomarkers for acquired mitochondrial disease in autism spectrum disorder. Transl Psychiatry. 2013 Jan 22;3(1):e220. doi: 10.1038/tp.2012.143.
citation: Fournier KA, Hass CJ, Naik SK, Lodha N, Cauraugh JH. Motor coordination in autism spectrum disorders: a synthesis and meta-analysis. J Autism Dev Disord. 2010 Oct;40(10):1227-40. doi: 10.1007/s10803-010-0981-3.
citation: Sigman M, Dijamco A, Gratier M, Rozga A. Early detection of core deficits in autism. Ment Retard Dev Disabil Res Rev. 2004;10(4):221-33. doi: 10.1002/mrdd.20046.
citation: Sigman M, Spence SJ, Wang AT. Autism from developmental and neuropsychological perspectives. Annu Rev Clin Psychol. 2006;2:327-55. doi: 10.1146/annurev.clinpsy.2.022305.095210.
citation: Iacoboni M, Dapretto M. The mirror neuron system and the consequences of its dysfunction. Nat Rev Neurosci. 2006 Dec;7(12):942-51. doi: 10.1038/nrn2024. Epub 2006 Nov 8.
citation: Association, A.P., Diagnostic and statistical manual of mental disorders; DSM-IV. Vol. 4th. 2000.
citation: Johnson CP, Myers SM; American Academy of Pediatrics Council on Children With Disabilities. Identification and evaluation of children with autism spectrum disorders. Pediatrics. 2007 Nov;120(5):1183-215. doi: 10.1542/peds.2007-2361. Epub 2007 Oct 29.
citation: Becker KG. Male gender bias in autism and pediatric autoimmunity. Autism Res. 2012 Apr;5(2):77-83. doi: 10.1002/aur.1227. Epub 2012 Mar 17.
citation: Schopler E, Reichler RJ, DeVellis RF, Daly K. Toward objective classification of childhood autism: Childhood Autism Rating Scale (CARS). J Autism Dev Disord. 1980 Mar;10(1):91-103. doi: 10.1007/BF02408436. No abstract available.
citation: Ozonoff S, Goodlin-Jones BL, Solomon M. Evidence-based assessment of autism spectrum disorders in children and adolescents. J Clin Child Adolesc Psychol. 2005 Sep;34(3):523-40. doi: 10.1207/s15374424jccp3403_8.
citation: Schopler E, v.B.M., Wellman GJ, Love SR, CARS2 Childhood Autism Rating Scale, second edition. WPS Publishing: Torrance, CA. 2010.
citation: Helt M, Kelley E, Kinsbourne M, Pandey J, Boorstein H, Herbert M, Fein D. Can children with autism recover? If so, how? Neuropsychol Rev. 2008 Dec;18(4):339-66. doi: 10.1007/s11065-008-9075-9. Epub 2008 Nov 14.
citation: Rogers SJ, Vismara LA. Evidence-based comprehensive treatments for early autism. J Clin Child Adolesc Psychol. 2008 Jan;37(1):8-38. doi: 10.1080/15374410701817808.
citation: Seltzer MM, Shattuck P, Abbeduto L, Greenberg JS. Trajectory of development in adolescents and adults with autism. Ment Retard Dev Disabil Res Rev. 2004;10(4):234-47. doi: 10.1002/mrdd.20038.
citation: Pickett E, Pullara O, O'Grady J, Gordon B. Speech acquisition in older nonverbal individuals with autism: a review of features, methods, and prognosis. Cogn Behav Neurol. 2009 Mar;22(1):1-21. doi: 10.1097/WNN.0b013e318190d185.
citation: Magiati I, Charman T, Howlin P. A two-year prospective follow-up study of community-based early intensive behavioural intervention and specialist nursery provision for children with autism spectrum disorders. J Child Psychol Psychiatry. 2007 Aug;48(8):803-12. doi: 10.1111/j.1469-7610.2007.01756.x.
citation: Fountain C, Winter AS, Bearman PS. Six developmental trajectories characterize children with autism. Pediatrics. 2012 May;129(5):e1112-20. doi: 10.1542/peds.2011-1601. Epub 2012 Apr 2.
citation: MM, S., EEG Waves Classifier using wavelet Transform and Fourier Transform. International Journal of Medical, Pharmaceutical Science and Engineering, 1(3): p. 77 - 82. 2007.
citation: Roberts TP, Schmidt GL, Egeth M, Blaskey L, Rey MM, Edgar JC, Levy SE. Electrophysiological signatures: magnetoencephalographic studies of the neural correlates of language impairment in autism spectrum disorders. Int J Psychophysiol. 2008 May;68(2):149-60. doi: 10.1016/j.ijpsycho.2008.01.012. Epub 2008 Feb 12.
citation: Kikuchi M, Yoshimura Y, Shitamichi K, Ueno S, Hirosawa T, Munesue T, Ono Y, Tsubokawa T, Haruta Y, Oi M, Niida Y, Remijn GB, Takahashi T, Suzuki M, Higashida H, Minabe Y. A custom magnetoencephalography device reveals brain connectivity and high reading/decoding ability in children with autism. Sci Rep. 2013;3:1139. doi: 10.1038/srep01139. Epub 2013 Jan 25.
citation: Kondacs A, Szabo M. Long-term intra-individual variability of the background EEG in normals. Clin Neurophysiol. 1999 Oct;110(10):1708-16. doi: 10.1016/s1388-2457(99)00122-4.
citation: Salinsky MC, Oken BS, Morehead L. Test-retest reliability in EEG frequency analysis. Electroencephalogr Clin Neurophysiol. 1991 Nov;79(5):382-92. doi: 10.1016/0013-4694(91)90203-g.
citation: Jin Y, R.A., Thai TM, Huang Y, Therapeutic application of transcranial magnetic stimulation in autism spectrum disorders. Autism Sci Digest, 3: p. 75-79.2010.
citation: Jin Y, Potkin SG, Kemp AS, Huerta ST, Alva G, Thai TM, Carreon D, Bunney WE Jr. Therapeutic effects of individualized alpha frequency transcranial magnetic stimulation (alphaTMS) on the negative symptoms of schizophrenia. Schizophr Bull. 2006 Jul;32(3):556-61. doi: 10.1093/schbul/sbj020. Epub 2005 Oct 27.
citation: Klimesch W. An algorithm for the EEG frequency architecture of consciousness and brain body coupling. Front Hum Neurosci. 2013 Nov 12;7:766. doi: 10.3389/fnhum.2013.00766. eCollection 2013. No abstract available.
citation: Melkerson, M., Special Premarket 510(k) Notification for NeuroStar® TMS Therapy System for Major Depressive Disorder. Food and Drug Administration. 2008.
citation: V, K., Letter to Brainsway Ltd:510K summary Brainsway Deep TMS system. Office of Device Evaluation, Center for Devices and Radiological Health, Food and Drug Administration. 2013.
citation: Release, F.N., FDA allows marketing of first device to relieve migraine headache pain: Cerena Transcranial Magnetic stimulation device. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm378608.htm. 2013.
citation: Jasper H, S.P., Bradley C, Electroencephalographic analyses of behavior problem children. Am J Psychiatry, 95: p. 641. 1938.
citation: Matsuura M, Okubo Y, Toru M, Kojima T, He Y, Hou Y, Shen Y, Lee CK. A cross-national EEG study of children with emotional and behavioral problems: a WHO collaborative study in the Western Pacific Region. Biol Psychiatry. 1993 Jul 1-15;34(1-2):59-65. doi: 10.1016/0006-3223(93)90257-e.
citation: Jeong J. EEG dynamics in patients with Alzheimer's disease. Clin Neurophysiol. 2004 Jul;115(7):1490-505. doi: 10.1016/j.clinph.2004.01.001.
citation: Locatelli T, Cursi M, Liberati D, Franceschi M, Comi G. EEG coherence in Alzheimer's disease. Electroencephalogr Clin Neurophysiol. 1998 Mar;106(3):229-37. doi: 10.1016/s0013-4694(97)00129-6.
citation: Loo SK, Makeig S. Clinical utility of EEG in attention-deficit/hyperactivity disorder: a research update. Neurotherapeutics. 2012 Jul;9(3):569-87. doi: 10.1007/s13311-012-0131-z.
citation: Monastra VJ, Lubar JF, Linden M, VanDeusen P, Green G, Wing W, Phillips A, Fenger TN. Assessing attention deficit hyperactivity disorder via quantitative electroencephalography: an initial validation study. Neuropsychology. 1999 Jul;13(3):424-433. doi: 10.1037/0894-4105.13.3.424.
citation: Barry RJ, Johnstone SJ, Clarke AR. A review of electrophysiology in attention-deficit/hyperactivity disorder: II. Event-related potentials. Clin Neurophysiol. 2003 Feb;114(2):184-98. doi: 10.1016/s1388-2457(02)00363-2.
citation: Snyder SM, Hall JR. A meta-analysis of quantitative EEG power associated with attention-deficit hyperactivity disorder. J Clin Neurophysiol. 2006 Oct;23(5):440-55. doi: 10.1097/01.wnp.0000221363.12503.78.
citation: Ogrim G, Kropotov J, Hestad K. The quantitative EEG theta/beta ratio in attention deficit/hyperactivity disorder and normal controls: sensitivity, specificity, and behavioral correlates. Psychiatry Res. 2012 Aug 15;198(3):482-8. doi: 10.1016/j.psychres.2011.12.041. Epub 2012 Mar 16.
citation: Spence SJ, Schneider MT. The role of epilepsy and epileptiform EEGs in autism spectrum disorders. Pediatr Res. 2009 Jun;65(6):599-606. doi: 10.1203/PDR.0b013e31819e7168.
citation: Wang J, Barstein J, Ethridge LE, Mosconi MW, Takarae Y, Sweeney JA. Resting state EEG abnormalities in autism spectrum disorders. J Neurodev Disord. 2013 Sep 16;5(1):24. doi: 10.1186/1866-1955-5-24.
citation: Lansbergen MM, Arns M, van Dongen-Boomsma M, Spronk D, Buitelaar JK. The increase in theta/beta ratio on resting-state EEG in boys with attention-deficit/hyperactivity disorder is mediated by slow alpha peak frequency. Prog Neuropsychopharmacol Biol Psychiatry. 2011 Jan 15;35(1):47-52. doi: 10.1016/j.pnpbp.2010.08.004. Epub 2010 Aug 13.
citation: Lansbergen MM, van Dongen-Boomsma M, Buitelaar JK, Slaats-Willemse D. ADHD and EEG-neurofeedback: a double-blind randomized placebo-controlled feasibility study. J Neural Transm (Vienna). 2011 Feb;118(2):275-84. doi: 10.1007/s00702-010-0524-2. Epub 2010 Dec 17.