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

Wave Neuroscience

Status: Completed

Conditions: Autistic Disorder

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT02746445

MeRT-015

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 6 to 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

11 participants in 1 patient group

ASD Subjects

Description:

No interventions. This is an observation of subjects who received MeRT utilizing assessment documentation.

Treatment:

Other: No intervention