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A Longitudinal Study on the Safety and Efficacy for Subjects With ASD Who Received MeRT

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ClinicalTrials.gov Identifier: NCT02746445
Recruitment Status : Completed
First Posted : April 21, 2016
Last Update Posted : May 9, 2017
Sponsor:
Information provided by (Responsible Party):
Wave Neuroscience

Tracking Information
First Submitted Date April 15, 2016
First Posted Date April 21, 2016
Last Update Posted Date May 9, 2017
Actual Study Start Date April 2016
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 20, 2016)
Change in Childhood Autism Rating Scale (CARS) [ Time Frame: Change from baseline CARS score at 104 weeks post-MeRT treatment ]
Symptom reduction in ASD will be measured using the arithmetic reduction in the CARS total score between two time points BL and week 104 (or Early Termination)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 20, 2016)
Childhood Autism Rating Scale (CARS) [ Time Frame: Baseline, weeks 5, 10, and 12, and 104 and 156 weeks post-MeRT treatment ]
Symptom reduction in ASD will be measured using the arithmetic reduction in the CARS total score between the multiple time points of the MeRT-001 trial (BL, Week 5, 10 and 12), BL, Follow-Up 1 Post-MeRT Treatment (Week 104), and Follow-Up 2 Post-MeRT Treatment (Week 156).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Longitudinal Study on the Safety and Efficacy for Subjects With ASD Who Received MeRT
Official Title A Longitudinal Study on the Safety and Efficacy for Subjects With Autism Spectrum Disorder (ASD) Who Received Magnetic EEG/ECG-Guided Resonance Therapy (MeRT)
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Twenty-eight (28) male and female individuals diagnosed with Autism Spectrum Disorder (ASD) who participated in the initial treatment protocol will be followed.
Condition Autistic Disorder
Intervention Other: No intervention
No intervention. This is a longitudinal study looking at subjects who received MeRT treatment.
Other Name: No intervention.
Study Groups/Cohorts ASD Subjects
No interventions. This is an observation of subjects who received MeRT utilizing assessment documentation.
Intervention: Other: No intervention
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 5, 2017)
11
Original Estimated Enrollment
 (submitted: April 20, 2016)
28
Actual Study Completion Date April 2017
Actual Primary Completion Date April 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

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

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Years to 15 Years   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02746445
Other Study ID Numbers MeRT-015
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Wave Neuroscience
Study Sponsor Wave Neuroscience
Collaborators Not Provided
Investigators
Principal Investigator: Keun-Young Kim, MD Brain Treatment Center
PRS Account Wave Neuroscience
Verification Date May 2017