Clincosm LogoSign in Get a demo

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

Sponsor
Wave Neuroscience (Industry)
Overall Status
Completed
CT.gov ID
NCT02746445
Collaborator
(none)
11
Enrollment
1
Location
12
Actual Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: No intervention

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 Design

Study Type:
Observational
Actual Enrollment :
11 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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)
Actual 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

No interventions. This is an observation of subjects who received MeRT utilizing assessment documentation.

Other: No intervention
No intervention. This is a longitudinal study looking at subjects who received MeRT treatment.
Other Names:
  • No intervention.

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Childhood Autism Rating Scale (CARS) [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)

    Secondary Outcome Measures

    1. Childhood Autism Rating Scale (CARS) [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 15 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    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

    Responsible Party:
    Wave Neuroscience
    ClinicalTrials.gov Identifier:
    NCT02746445
    Other Study ID Numbers:
    • MeRT-015
    First Posted:
    Apr 21, 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
    Autism
    ASD
    Autism Spectrum Disorder
    Additional relevant MeSH terms:
    Autism Spectrum Disorder
    Autistic Disorder

    Study Results

    No Results Posted as of May 9, 2017