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

Completed

• Conditions: Autistic Disorder
• Interventions: Other: No intervention

• Registration Number: NCT02746445
• Lead Sponsor: Wave Neuroscience

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-15
• Study First Submitted QC: 2016-04-20
• Study First Posted: 2016-04-21
• Primary Completion: 2017-04
• Study Completion: 2017-04
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-05
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ASD Subjects	No intervention	No interventions. This is an observation of subjects who received MeRT utilizing assessment documentation.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (1)

Brain Treatment Center; 🇺🇸 Newport Beach, California, United States