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Completed

NCT Number: NCT02758496

A Chart Review to Evaluate the Safety and Efficacy of MeRT on Subjects With ASD

The purpose of this study is to evaluate the safety and efficacy of Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) on subjects with Autism Spectrum Disorder (ASD).

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Key information

Conditions

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

Age range

2 year–20 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Brain Treatment Center

Newport Beach, California, 92660, United States

About this study

This is a retrospective chart review of 200 consecutive charts of subjects ages 2-20 years old seen at the Brain Treatment Center between 2010 and 2015. The review is designed to evaluate the safety and efficacy of Magnetic Electroencephalogram/Electrocardiogram(EEG/ECG)-Guided Resonance Therapy (MeRT) on subjects with Autism Spectrum Disorder (ASD).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Must have completed a baseline EEG at the Brain Treatment Center (BTC)
  • Age between 2 and 20 years old at initial visit
  • Must have a diagnosis of ASD according to the prevailing standard at that time (i.e., Diagnostic and Statistical Manual-IV (DSM-IV)) (ASD Group only)
  • Must have received Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) for more than (5) sessions (ASD Group only)

Exclusion criteria

  • Clinically significant abnormality or clinically significant unstable medical condition during treatment that in the Investigator's judgment may have may limited interpretation of the results.

Treatment and study plan

MeRT Efficacy Chart Review

Other

There will be not intervention. This is a chart review.

Primary outcomes

  1. Childhood Autism Rating Scale (CARS)

    Time frame: Baseline through study completion, an average of 36 months

    Symptom reduction in ASD will be measured using the reduction in the CARS between two time points: Baseline (BL) CARS and Final CARS Evaluation.

Secondary outcomes

  1. Electrophysiological

    Time frame: Baseline through study completion, an average of 36 months

    Changes in quantitative electroencephalogram (qEEG), will be measured with emphasis on the overall changes between two timepoints: BL EEG and Final EEG.

Sponsors and collaborators

Lead sponsor

Wave Neuroscience

Industry

Registry information

Official study title

A Chart Review to Evaluate the Safety and Efficacy of Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) on Subjects With Autism Spectrum Disorder (ASD)

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 2, 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.

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