Clinical trial NCT02746445: A Longitudinal Study on the Safety and Efficacy for Subjects With ASD Who Received MeRT
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autistic Disorder
Keywords: Autism
ASD
Autism Spectrum Disorder
Lead sponsor: Wave Neuroscience
Sponsor class: INDUSTRY
First posted: 2016-04-21
Enrollment: 11
Sex: ALL
Minimum age (years): 6
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in Childhood Autism Rating Scale (CARS)
timeFrame: Change from baseline CARS score at 104 weeks post-MeRT treatment
Secondary outcomes:
measure: Childhood Autism Rating Scale (CARS)
timeFrame: Baseline, weeks 5, 10, and 12, and 104 and 156 weeks post-MeRT treatment
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: Brain Treatment Center
state: California
Study officials:
affiliation: Brain Treatment Center
name: Keun-Young Kim, MD
role: PRINCIPAL_INVESTIGATOR
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