A Chart Review to Evaluate the Safety and Efficacy of MeRT on Subjects With ASD
Sponsor
Wave Neuroscience (Industry)
Overall Status
Completed
CT.gov ID
NCT02758496
Collaborator
(none)
141
1
12
11.8
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Study Type:
Observational
Actual Enrollment
:
141 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
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)
Study Start Date
:
Apr 1, 2016
Actual Primary Completion Date
:
Apr 1, 2017
Actual Study Completion Date
:
Apr 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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
There will be not intervention. This is a 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
There will be not intervention. This is a chart review.
|
Outcome Measures
Primary Outcome Measures
- 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
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
2 Years
to 20 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Brain Treatment Center | Newport Beach | California | United States | 92660 |
Sponsors and Collaborators
- Wave Neuroscience
Investigators
- Principal Investigator: Keun-Young Kim, MD, Brain Treatment Center
Study Documents (Full-Text)
None provided.More Information
Publications
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Responsible Party:
Wave Neuroscience
ClinicalTrials.gov Identifier:
NCT02758496
Other Study ID Numbers:
- MeRT-016
First Posted:
May 2, 2016
Last Update Posted:
May 9, 2017
Last Verified:
May 1, 2017
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Wave Neuroscience
Additional relevant MeSH terms: