Skip to main content
OpenTrials
Completed

NCT Number: NCT02746445

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autistic Disorder Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

6 year–15 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Brain Treatment Center

Newport Beach, California, 92660, United States

About 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

No intervention

Other

No intervention. This is a longitudinal study looking at subjects who received MeRT treatment.

Other names: No intervention.

Primary outcomes

  1. 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

  1. Childhood Autism Rating Scale (CARS)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Wave Neuroscience

Industry

Registry information

Official study title

A Longitudinal Study on the Safety and Efficacy for Subjects With Autism Spectrum Disorder (ASD) Who Received Magnetic EEG/ECG-Guided Resonance Therapy (MeRT)

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 21, 2016
Registry last updated
May 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.