A Longitudinal Study on the Safety and Efficacy for Subjects With ASD Who Received MeRT
NCT ID: NCT02746445
Last Updated: 2017-05-09
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Total Enrollment
11 participants
Study Classification
OBSERVATIONAL
Study Start Date
2016-04-30
Study Completion Date
2017-04-30
Brief Summary
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The purpose of this study is to continue to evaluate the long-term effectiveness of Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) in children with Autism Spectrum Disorder (ASD). No active MeRT treatment will be performed in this study.
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Detailed Description
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This clinical trial is a longitudinal study designed to evaluate the safety and efficacy for subjects with Autism Spectrum Disorder (ASD) who received Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) in the IRB approved clinical trial. A total of twenty-eight (28) subjects will be followed in this study. After providing informed consent, twenty-eight (28) subjects who participated in the previous protocol will be observed for up to three (3) years post-MeRT treatment. During this period, subjects will be evaluated at 104 and 156 weeks post-MeRT treatment.
Conditions
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Autistic Disorder
Study Design
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Observational Model Type
COHORT
Study Time Perspective
PROSPECTIVE
Study Groups
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ASD Subjects
No interventions. This is an observation of subjects who received MeRT utilizing assessment documentation.
No intervention
Intervention Type
OTHER
No intervention. This is a longitudinal study looking at subjects who received MeRT treatment.
Interventions
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No intervention
No intervention. This is a longitudinal study looking at subjects who received MeRT treatment.
Intervention Type
OTHER
Other Intervention Names
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No intervention.
Eligibility Criteria
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Inclusion Criteria
1. Subject must have completed the MeRT-001 (formerly known as MRT-001) clinical trial conducted by the Brain Treatment Center (BTC)
2. Age between 6 and 15 years (at day of informed consent)
3. Willing and able to adhere to the study visits
2. Age between 6 and 15 years (at day of informed consent)
3. Willing and able to adhere to the study visits
Exclusion Criteria
1. Subjects who did not participate in the MeRT-001 clinical trial.
2. Any condition which in the judgment of the investigator would prevent the subject from completion of the study.
2. Any condition which in the judgment of the investigator would prevent the subject from completion of the study.
Minimum Eligible Age
6 Years
Maximum Eligible Age
15 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Wave Neuroscience
INDUSTRY
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Keun-Young Kim, MD
Role: PRINCIPAL_INVESTIGATOR
Brain Treatment Center
Locations
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Brain Treatment Center
Newport Beach, California, United States
Site Status
Countries
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United States
References
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Other Identifiers
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MeRT-015
Identifier Type: -
Identifier Source: org_study_id
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