Home
Clinical Trials
A Chart Review to Evaluate th...

A Chart Review to Evaluate the Safety and Efficacy of MeRT on Subjects With ASD

Last Updated: 2017-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

141 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Longitudinal Study on the Safety and Efficacy for Subjects With ASD Who Received MeRT

NCT02746445

Autistic Disorder

COMPLETED

A Trial To Evaluate The Efficacy of Magnetic Resonant Therapy in Autism

NCT01985308

Autism Spectrum Disorder

COMPLETED NA

The Therapeutic Effects of Intermittent Theta Burst Stimulation in Autism Spectrum Disorder

NCT04987749

Autism Spectrum Disorder

UNKNOWN NA

Therapeutic Impacts of Theta Burst Stimulation Over Bilateral Posterior Superior Temporal Sulcus in Autism Spectrum Disorder

NCT05578209

Autism Spectrum Disorder

ACTIVE_NOT_RECRUITING NA

Explore the Impacts of One Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder

NCT05578261

Autism Spectrum Disorder

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Autistic Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ASD Subjects

Approximately 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 (BTC) between 2010 and 2015.

MeRT Efficacy Chart Review

Intervention Type OTHER

There will be not intervention. This is a chart review.

Healthy Controls

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

MeRT Efficacy Chart Review

Intervention Type OTHER

There will be not intervention. This is a chart review.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MeRT Efficacy Chart Review

There will be not intervention. This is a chart review.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Keun-Young Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Brain Treatment Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brain Treatment Center

Newport Beach, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND

PMID: 22492772 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 19541375 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 19955444 (View on PubMed)

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.

Reference Type BACKGROUND

Sudhof TC. Neuroligins and neurexins link synaptic function to cognitive disease. Nature. 2008 Oct 16;455(7215):903-11. doi: 10.1038/nature07456.

Reference Type BACKGROUND

PMID: 18923512 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 19819542 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 16772313 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 20048083 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 18956240 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 18258309 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 8120818 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 16119476 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 18701743 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 18172517 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 17001340 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 15870155 (View on PubMed)

Geschwind DH. Autism: many genes, common pathways? Cell. 2008 Oct 31;135(3):391-5. doi: 10.1016/j.cell.2008.10.016.

Reference Type BACKGROUND

PMID: 18984147 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12094096 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 21220394 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 17363630 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 18252227 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 18184952 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 16721319 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 19582867 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 10638459 (View on PubMed)

Beaudet AL. Autism: highly heritable but not inherited. Nat Med. 2007 May;13(5):534-6. doi: 10.1038/nm0507-534. No abstract available.

Reference Type BACKGROUND

PMID: 17479094 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 17971078 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 9016266 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 19043581 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 23340503 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 20195737 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 15666338 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 17716073 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 17115076 (View on PubMed)

Association, A.P., Diagnostic and statistical manual of mental disorders; DSM-IV. Vol. 4th. 2000.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

PMID: 17967920 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 22431266 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 6927682 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 16083393 (View on PubMed)

Schopler E, v.B.M., Wellman GJ, Love SR, CARS2 Childhood Autism Rating Scale, second edition. WPS Publishing: Torrance, CA. 2010.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

PMID: 19009353 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 18444052 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 15666341 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 19372766 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 17683452 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 22473372 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

PMID: 18336941 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 23355952 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 10574286 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 1718711 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

PMID: 16254067 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 24273507 (View on PubMed)

Melkerson, M., Special Premarket 510(k) Notification for NeuroStar® TMS Therapy System for Major Depressive Disorder. Food and Drug Administration. 2008.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

Jasper H, S.P., Bradley C, Electroencephalographic analyses of behavior problem children. Am J Psychiatry, 95: p. 641. 1938.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

PMID: 8373939 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 15203050 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 9743281 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 22814935 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 10447303 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 12559225 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 17016156 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 22425468 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 19454962 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 24040879 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 20713113 (View on PubMed)

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.

Reference Type BACKGROUND

PMID: 21165661 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MeRT-016

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Efficacy and Mechanism of Repetitive Transcranial Magnetic Stimulation in Children With Autism Spectrum Disorders

NCT05927792 COMPLETED PHASE2/PHASE3

Non-Helium Magnetoencephalography in Autism Spectrum Disorder

NCT07064967 RECRUITING

CBCT for Parents of Children With Autism

NCT02574559 COMPLETED NA

Brain Hero® Neurofeedback Training (With the Device Brainhero 2019, Type 201)

NCT05444816 COMPLETED NA

The Therapeutic Effects of Continuous Theta Burst Stimulation in Autism Spectrum Disorder

NCT04993144 UNKNOWN NA

Magnetic Resonance Spectroscopic and Diffusion Tensor Imaging of Adolescents with Autism Spectrum Disorders

NCT01361503 COMPLETED

Cognitive Control and Metacognition Training

NCT06885684 NOT_YET_RECRUITING NA

Neurofeedback Therapy for Children Diagnosed With Autism

NCT02773303 COMPLETED NA

The Impacts of Theta-burst Stimulation on Children and Adolescents With Autism Spectrum Disorder

NCT03621189 COMPLETED NA

Investigation of Brain Plasticity in Autism Spectrum Disorders

NCT04706364 UNKNOWN

ABC-CT Pre-School Feasibility Study

NCT06413316 COMPLETED

Neuroimaging Predictors of Improvement to Pivotal Response Treatment (PRT) in Young Children With Autism

NCT03583684 RECRUITING NA

Photobiomodulation in Autism Spectrum Disorder (ASD)

NCT03724552 COMPLETED NA

Explore the Therapeutic Effect of Theta Burst Stimulation on Emotion Regulation in Autism With Minimally Verbal Ability or Intellectual Disability

NCT06974838 NOT_YET_RECRUITING NA

Understanding the Mechanisms of Autism : an MRI and Social Cognition Study

NCT06334588 RECRUITING NA

Treatment to Promote Self-regulation in Children With Autism Spectrum Disorder

NCT05235919 RECRUITING PHASE2

Transcranial Magnetic Stimulation Studies in Autism Spectrum Disorders

NCT02591446 COMPLETED

Therapeutic Intervention Effects of rTMS on Children With Autism Spectrum Disorder

NCT05140356 UNKNOWN NA

Efficacy and Mechanism of rTMS in Children With ASD: an Open-label Clinical Trial

NCT05238298 COMPLETED NA

Transcranial Magnetic Stimulation on Neural and Behavioral Facets of Social Cognition in Autism Spectrum Disorder

NCT04242355 ACTIVE_NOT_RECRUITING NA

Electromagnetic Therapy for Autism Spectrum Disorder

NCT06085287 RECRUITING NA

Neurofeedback Training for Autistic Children

NCT07149974 ENROLLING_BY_INVITATION NA

Enhancement of Behavioral and Cognitive Outcomes in Autism Spectrum Disorder Via Neurostimulation

NCT05371912 COMPLETED NA

Explore the Impacts of One Session and Multiple Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder

NCT07114770 RECRUITING NA

Development of Eye-tracking Based Markers for Autism in Young Children

NCT03286621 COMPLETED

A Chart Review to Evaluate the Safety and Efficacy of MeRT on Subjects With ASD

Study Results

Basic Information

Brief Summary

Related Clinical Trials

A Longitudinal Study on the Safety and Efficacy for Subjects With ASD Who Received MeRT

A Trial To Evaluate The Efficacy of Magnetic Resonant Therapy in Autism

The Therapeutic Effects of Intermittent Theta Burst Stimulation in Autism Spectrum Disorder

Therapeutic Impacts of Theta Burst Stimulation Over Bilateral Posterior Superior Temporal Sulcus in Autism Spectrum Disorder

Explore the Impacts of One Session Theta Burst Stimulation Over Cerebellum in Adults With Autism Spectrum Disorder

Detailed Description

Conditions

Study Design

Study Groups

ASD Subjects

MeRT Efficacy Chart Review

Healthy Controls

MeRT Efficacy Chart Review

Interventions

MeRT Efficacy Chart Review

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Wave Neuroscience

Responsible Party

Principal Investigators

Keun-Young Kim, MD

Locations

Brain Treatment Center

Countries

References

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.

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.

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.

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.

Sudhof TC. Neuroligins and neurexins link synaptic function to cognitive disease. Nature. 2008 Oct 16;455(7215):903-11. doi: 10.1038/nature07456.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Geschwind DH. Autism: many genes, common pathways? Cell. 2008 Oct 31;135(3):391-5. doi: 10.1016/j.cell.2008.10.016.

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.

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.

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.

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.

Beaudet AL. Autism: highly heritable but not inherited. Nat Med. 2007 May;13(5):534-6. doi: 10.1038/nm0507-534. No abstract available.

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.

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.

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.

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.

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.

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.

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.

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.

Association, A.P., Diagnostic and statistical manual of mental disorders; DSM-IV. Vol. 4th. 2000.

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.

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.

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.

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.

Schopler E, v.B.M., Wellman GJ, Love SR, CARS2 Childhood Autism Rating Scale, second edition. WPS Publishing: Torrance, CA. 2010.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Melkerson, M., Special Premarket 510(k) Notification for NeuroStar® TMS Therapy System for Major Depressive Disorder. Food and Drug Administration. 2008.

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.