An observational study in Autistic Disorder, sponsored by Wave Neuroscience. Completed at 1 site in United States. Open to participants aged 6 Years to 15 Years. Per ClinicalTrials.gov, last updated 2017-05-09.
Sponsored by Wave Neuroscience · Observational
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.
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.
1,727 studies on the registry are indexed under Autism Spectrum Disorder; 504 are open to participants now.
This study's enrollment of 11 is below the median of 102 across 321 observational studies indexed under Autism Spectrum Disorder.
Browse Autism Spectrum Disorder studies →Wave Neuroscience is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Twenty-eight (28) male and female individuals diagnosed with Autism Spectrum Disorder (ASD) who participated in the initial treatment protocol will be followed.
Exclusion Criteria:
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.
Also known as: No intervention.
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)
Time frame: Change from baseline CARS score at 104 weeks post-MeRT treatment
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).
Time frame: Baseline, weeks 5, 10, and 12, and 104 and 156 weeks post-MeRT treatment
Plan to share: No
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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