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Clinical Trials/NCT02758496
NCT02758496
Completed
Not Applicable

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

Wave Neuroscience1 site in 1 country141 target enrollmentApril 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autistic Disorder
Sponsor
Wave Neuroscience
Enrollment
141
Locations
1
Primary Endpoint
Childhood Autism Rating Scale (CARS)
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

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).

Detailed Description

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).

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
April 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Wave Neuroscience
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Electrophysiological(Baseline through study completion, an average of 36 months)

Study Sites (1)

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