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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Autistic Disorder

Intervention / Treatment
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* Other: No intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject must have completed the MeRT-001 (formerly known as MRT-001) clinical trial conducted by the Brain Treatment Center (BTC) Age between 6 and 15 years (at day of informed consent) Willing and able to adhere to the study visits Exclusion Criteria: Subjects who did not participate in the MeRT-001 clinical trial. Any condition which in the judgment of the investigator would prevent the subject from completion of the study.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ASD Subjects<br>No interventions. This is an observation of subjects who received MeRT utilizing assessment documentation. | Other: No intervention<br>* No intervention. This is a longitudinal study looking at subjects who received MeRT treatment.<br>* Other names: No intervention.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Autism, ASD, Autism Spectrum Disorder