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

NCT02758496 | Completed

• 1 other identifier: MeRT-016
• Study Type: observational
• Target: 141
• Locations: 1 country
• Sites: 1

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).

Conditions

Autistic Disorder

Keywords

Autism, chart review, transcranial magnetic stimulation (TMS)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Electrophysiological

  Baseline through study completion, an average of 36 months

Study Arms (2)

ASD Subjects

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.

Other: MeRT Efficacy Chart Review

Healthy Controls

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

Other: MeRT Efficacy Chart Review

Interventions

MeRT Efficacy Chart Review OTHER

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

ASD Subjects; Healthy Controls

Eligibility Criteria

• Age: 2 Years - 20 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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 between 2010 and 2015. 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wave Neuroscience: lead

Study Sites (1)

Brain Treatment Center

Newport Beach, California, 92660, United States

Location

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MeSH Terms

Conditions

Autistic Disorder

Condition Hierarchy (Ancestors)

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

Study Officials

• Keun-Young Kim, MD

  Brain Treatment Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2016
• First Posted: May 2, 2016
• Study Start: April 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: May 9, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)