A Longitudinal Study on the Safety and Efficacy for Subjects With Autism Spectrum Disorder (ASD) Who Received Magnetic EEG/ECG-Guided Resonance Therapy (MeRT)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Autistic Disorder
- Sponsor
- Wave Neuroscience
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Change in Childhood Autism Rating Scale (CARS)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
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 Outcomes
- Childhood Autism Rating Scale (CARS)(Baseline, weeks 5, 10, and 12, and 104 and 156 weeks post-MeRT treatment)