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

Autistic Disorder Clinical Trial

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02758496
• Other study ID #: MeRT-016
• Status: Completed
• Phase: N/A
• First received: April 15, 2016
• Last updated: May 5, 2017
• Start date: April 2016
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: Newport Brain Research Laboratory
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 141
• Est. completion date: April 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 20 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autistic Disorder

Intervention

Other:
• MeRT Efficacy Chart Review
There will be not intervention. This is a chart review.

Locations

Country	Name	City	State
United States	Brain Treatment Center	Newport Beach	California

Sponsors (1)

Lead Sponsor	Collaborator
Newport Brain Research Laboratory

Country where clinical trial is conducted

United States, 

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Childhood Autism Rating Scale (CARS)	Symptom reduction in ASD will be measured using the reduction in the CARS between two time points: Baseline (BL) CARS and Final CARS Evaluation.	Baseline through study completion, an average of 36 months
Secondary	Electrophysiological	Changes in quantitative electroencephalogram (qEEG), will be measured with emphasis on the overall changes between two timepoints: BL EEG and Final EEG.	Baseline through study completion, an average of 36 months