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

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ClinicalTrials.gov Identifier: NCT02758496
Recruitment Status : Completed
First Posted : May 2, 2016
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Wave Neuroscience

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).

Condition or disease Intervention/treatment
Autistic Disorder Other: MeRT Efficacy Chart Review

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).

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Study Type : Observational
Actual Enrollment : 141 participants
Observational Model: Cohort
Time Perspective: Retrospective
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 Start Date : April 2016
Actual Primary Completion Date : April 2017
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: MeRT Efficacy Chart Review
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
Other: MeRT Efficacy Chart Review
There will be not intervention. This is a chart review.




Primary Outcome Measures :
  1. Childhood Autism Rating Scale (CARS) [ Time Frame: Baseline through study completion, an average of 36 months ]
    Symptom reduction in ASD will be measured using the reduction in the CARS between two time points: Baseline (BL) CARS and Final CARS Evaluation.


Secondary Outcome Measures :
  1. Electrophysiological [ Time Frame: Baseline through study completion, an average of 36 months ]
    Changes in quantitative electroencephalogram (qEEG), will be measured with emphasis on the overall changes between two timepoints: BL EEG and Final EEG.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02758496


Locations
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United States, California
Brain Treatment Center
Newport Beach, California, United States, 92660
Sponsors and Collaborators
Wave Neuroscience
Investigators
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Principal Investigator: Keun-Young Kim, MD Brain Treatment Center
Publications:
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.
Association, A.P., Diagnostic and statistical manual of mental disorders; DSM-IV. Vol. 4th. 2000.
Schopler E, v.B.M., Wellman GJ, Love SR, CARS2 Childhood Autism Rating Scale, second edition. WPS Publishing: Torrance, CA. 2010.
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.
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.
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.
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.
Jasper H, S.P., Bradley C, Electroencephalographic analyses of behavior problem children. Am J Psychiatry, 95: p. 641. 1938.
Ogrim G, K.J., Hestad K, The QEEG theta/beta ratio in ADHD and normal control: sensitivity, specificity and behavioral correlates. Psychiatry Res, 2012. doi: 10.1016/j.psychres.2011.

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Responsible Party: Wave Neuroscience
ClinicalTrials.gov Identifier: NCT02758496    
Other Study ID Numbers: MeRT-016
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: May 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Wave Neuroscience:
Autism, chart review, transcranial magnetic stimulation (TMS)
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders