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

Autistic Disorder Clinical Trial

Official title:

A Longitudinal Study on the Safety and Efficacy for Subjects With Autism Spectrum Disorder (ASD) Who Received Magnetic EEG/ECG-Guided Resonance Therapy (MeRT)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02746445
• Other study ID #: MeRT-015
• Status: Completed
• Phase: N/A
• First received: April 15, 2016
• Last updated: May 5, 2017
• Start date: April 2016
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: Newport Brain Research Laboratory
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to continue to evaluate the long-term effectiveness of Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) in children with Autism Spectrum Disorder (ASD). No active MeRT treatment will be performed in this study.

Description:

This clinical trial is a longitudinal study designed to evaluate the safety and efficacy for subjects with Autism Spectrum Disorder (ASD) who received Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) in the IRB approved clinical trial. A total of twenty-eight (28) subjects will be followed in this study. After providing informed consent, twenty-eight (28) subjects who participated in the previous protocol will be observed for up to three (3) years post-MeRT treatment. During this period, subjects will be evaluated at 104 and 156 weeks post-MeRT treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 15 Years

Eligibility

Inclusion Criteria:

1. Subject must have completed the MeRT-001 (formerly known as MRT-001) clinical trial conducted by the Brain Treatment Center (BTC)

2. Age between 6 and 15 years (at day of informed consent)

3. Willing and able to adhere to the study visits

Exclusion Criteria:

1. Subjects who did not participate in the MeRT-001 clinical trial.

2. Any condition which in the judgment of the investigator would prevent the subject from completion of the study.

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Other:
• No intervention
No intervention. This is a longitudinal study looking at subjects who received MeRT treatment.

Locations

Country	Name	City	State
United States	Brain Treatment Center	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Newport Brain Research Laboratory

Country where clinical trial is conducted

United States, 

References & Publications (48)

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. Review. — View Citation

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

Beaudet AL. Autism: highly heritable but not inherited. Nat Med. 2007 May;13(5):534-6. — View 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. Review. — View 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. Review. — View 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. Erratum in: J Autism Dev Disord. 2007 Oct;37(9):1822. Gillberg, Carina [corrected to Gillberg, I Carina]. — View 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. — View 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. — View 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 1:1736-41. doi: 10.1073/pnas.0906080106. Epub 2009 Dec 1. Review. — View 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. Review. Erratum in: J Autism Dev Disord 2000 Feb;30(1):81. — View 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. — View 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. — View 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:e220. doi: 10.1038/tp.2012.143. — View Citation

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

Happé F, Ronald A, Plomin R. Time to give up on a single explanation for autism. Nat Neurosci. 2006 Oct;9(10):1218-20. Review. — View Citation

Happé 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. Review. — View 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. Review. — View Citation

Hultman CM, Sparén P, Cnattingius S. Perinatal risk factors for infantile autism. Epidemiology. 2002 Jul;13(4):417-23. — View Citation

Iacoboni M, Dapretto M. The mirror neuron system and the consequences of its dysfunction. Nat Rev Neurosci. 2006 Dec;7(12):942-51. Epub 2006 Nov 8. Review. — View 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. Epub 2007 Oct 29. Review. — View 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. Epub 2006 Jun 13. — View 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. — View 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. — View 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. — View Citation

Långström N, Grann M, Ruchkin V, Sjöstedt 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. — View 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. — View 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. Review. Erratum in: Lancet. 2011 Oct 29;378(9802):1546. — View 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. — View 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. — View 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.

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. Review. — View 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. Review. — View 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. — View 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. Review. — View 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. Review. — View 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. Review. — View 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. — View Citation

Ronald A, Happé 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):691-9. — View Citation

Schmitz C, Rezaie P. The neuropathology of autism: where do we stand? Neuropathol Appl Neurobiol. 2008 Feb;34(1):4-11. Epub 2007 Oct 26. Review. — View 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. — View Citation

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

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, Lehtimäki 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. Epub 2007 Mar 15. — View 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. Review. — View 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. Review. — View Citation

Sigman M, Spence SJ, Wang AT. Autism from developmental and neuropsychological perspectives. Annu Rev Clin Psychol. 2006;2:327-55. Review. — View Citation

Stigler KA, S.T., Posey DJ, McDougle CJ, Autism and immune factors: a comprehensive review. Res Autism Spectr Disord 3(4): 840-860. 2009.

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. — View 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. — View Citation

* Note: There are 48 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Childhood Autism Rating Scale (CARS)	Symptom reduction in ASD will be measured using the arithmetic reduction in the CARS total score between two time points BL and week 104 (or Early Termination)	Change from baseline CARS score at 104 weeks post-MeRT treatment
Secondary	Childhood Autism Rating Scale (CARS)	Symptom reduction in ASD will be measured using the arithmetic reduction in the CARS total score between the multiple time points of the MeRT-001 trial (BL, Week 5, 10 and 12), BL, Follow-Up 1 Post-MeRT Treatment (Week 104), and Follow-Up 2 Post-MeRT Treatment (Week 156).	Baseline, weeks 5, 10, and 12, and 104 and 156 weeks post-MeRT treatment