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Autistic DisorderNCT02758496

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

An observational study of Autistic Disorder, run by Wave Neuroscience at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 2 to 20 yearsHealthy volunteers can take part
Conditions the study is for
Autistic Disorder
What is being tested?
MeRT Efficacy Chart Review
How many people
141 participants
Where
1 siteUnited States
Study dates
Apr 2016to Apr 2017
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 to 20 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

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.

Who may be able to join

  • Must have completed a baseline EEG at the Brain Treatment Center (BTC)
  • Age between 2 and 20 years old at initial visit
  • 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)
  • Must have received Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) for more than (5) sessions (ASD Group only)

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Brain Treatment Center

    Newport Beach, California, 92660

Other trials in United States

About this study

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)

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).

Read the 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).

Being tested
MeRT Efficacy Chart Review
Keywords
Autism, chart review, transcranial magnetic stimulation (TMS)
Medical subject headings
Autistic Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MeRT Efficacy Chart ReviewOther

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

Study groups in NCT02758496
Study groupRoleWhat they receive
ASD SubjectsApproximately 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.
Receives: Other: MeRT Efficacy Chart Review
Healthy ControlsTwenty (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
Receives: Other: MeRT Efficacy Chart Review

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Childhood Autism Rating Scale (CARS)

    Symptom reduction in ASD will be measured using the reduction in the CARS between two time points: Baseline (BL) CARS and Final CARS Evaluation.

    Measured: Baseline through study completion, an average of 36 months

Secondary outcomes (1)

  1. Electrophysiological

    Changes in quantitative electroencephalogram (qEEG), will be measured with emphasis on the overall changes between two timepoints: BL EEG and Final EEG.

    Measured: Baseline through study completion, an average of 36 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 May 2016 (estimated)
  2. Study startApr 2016
  3. Primary completionApr 2017
  4. Study completionApr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
141 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02758496
Sponsor's protocol ID
MeRT-016
Status last verified
May 2017
First submitted
15 Apr 2016
Last updated
9 May 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22492772

  • 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.

    PubMed 19541375

  • 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.

    PubMed 19955444

  • 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.

    PubMed 18923512

  • 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.

    PubMed 19819542

  • 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.

    PubMed 16772313

  • 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.

    PubMed 20048083

  • 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.

    PubMed 18956240

  • 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.

    PubMed 18258309

  • 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.

    PubMed 8120818

  • 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.

    PubMed 16119476

  • 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.

    PubMed 18701743

  • 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.

    PubMed 18172517

  • 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.

    PubMed 17001340

Questions about this trial

What is this clinical trial studying?

An observational study of Autistic Disorder, run by Wave Neuroscience at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Childhood Autism Rating Scale (CARS) (time frame: Baseline through study completion, an average of 36 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02758496, which also lists 70 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.

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