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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02746445
Recruitment Status : Completed
First Posted : April 21, 2016
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Wave Neuroscience

Brief 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.

Condition or disease Intervention/treatment
Autistic Disorder Other: No intervention

Detailed 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.

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Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual 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
No interventions. This is an observation of subjects who received MeRT utilizing assessment documentation.
Other: No intervention
No intervention. This is a longitudinal study looking at subjects who received MeRT treatment.
Other Name: No intervention.




Primary Outcome Measures :
  1. Change in Childhood Autism Rating Scale (CARS) [ Time Frame: Change from baseline CARS score at 104 weeks post-MeRT treatment ]
    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)


Secondary Outcome Measures :
  1. Childhood Autism Rating Scale (CARS) [ Time Frame: Baseline, weeks 5, 10, and 12, and 104 and 156 weeks post-MeRT treatment ]
    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).



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Ages Eligible for Study:   6 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Twenty-eight (28) male and female individuals diagnosed with Autism Spectrum Disorder (ASD) who participated in the initial treatment protocol will be followed.
Criteria

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.

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): NCT02746445


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): 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.

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Responsible Party: Wave Neuroscience
ClinicalTrials.gov Identifier: NCT02746445    
Other Study ID Numbers: MeRT-015
First Posted: April 21, 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
ASD
Autism Spectrum Disorder
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Autistic Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders