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

Completed

• Conditions: Autistic Disorder
• Interventions: Other: MeRT Efficacy Chart Review

• Registration Number: NCT02758496
• Lead Sponsor: Wave Neuroscience

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).

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-15
• Study First Submitted QC: 2016-04-29
• Study First Posted: 2016-05-02
• 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: 141

Inclusion Criteria

1. Must have completed a baseline EEG at the Brain Treatment Center (BTC)
2. Age between 2 and 20 years old at initial visit
3. 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)
4. Must have received Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) for more than (5) sessions (ASD Group only)

Exclusion Criteria

5. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ASD Subjects	MeRT Efficacy Chart Review	Approximately two hundred (200) male and female subjects of any ethnic background between the ages of 2-20 years old seen at the Brain Treatment Center (BTC) between 2010 and 2015.
Healthy Controls	MeRT Efficacy Chart Review	Twenty (20) male and female subjects of any ethnic background between the ages of 2-20 years old with 'neurotypical' EEGs will be selected for comparison to the ASD group

Primary Outcome Measures

Name	Time	Method
Childhood Autism Rating Scale (CARS)	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 Outcome Measures

Name	Time	Method
Electrophysiological	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.

Trial Locations

Locations (1)

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