Autistic Disorder
Conditions
Keywords
Autism, ASD, Autism Spectrum Disorder
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.
Interventions
OTHERNo intervention
No intervention. This is a longitudinal study looking at subjects who received MeRT treatment.
Sponsors
Wave Neuroscience
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Childhood Autism Rating Scale (CARS) | 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
| Measure | Time frame | Description |
|---|---|---|
| Childhood Autism Rating Scale (CARS) | 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). |
Countries
United States
Outcome results
None listed