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A Trial To Evaluate The Efficacy of Magnetic Resonant Therapy in Autism

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ClinicalTrials.gov Identifier: NCT01985308
Recruitment Status : Completed
First Posted : November 15, 2013
Last Update Posted : April 16, 2014
Sponsor:
Information provided by (Responsible Party):
Wave Neuroscience

Study Description
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Brief Summary:
The purpose of this study is to show that a magnetic field applied to the front part of the brain of children suffering from Autism Spectrum Disorder(ASD) can improve function and ameliorate symptoms.

Condition or disease Intervention/treatment Phase
Autism Spectrum Disorder Device: MRT-Active Device: MRT-SHAM Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Double-Blind Sham-Controlled Trial To Evaluate The Treatment Efficacy of Magnetic Resonant Therapy in Autistic Disorder
Study Start Date : November 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: MRT-Active
Magnetic Field, modulated as per EEG analysis, is active for 6 seconds every minute for 30 minutes per day, 5 days per week x 5 weeks.
 Device: MRT-Active
Sham Comparator: MRT-SHAM
Magnetic field is not active, but a sham coil is used, for 6 seconds every minute for 30 minutes per day, 5 days per week x 5 weeks.
 Device: MRT-SHAM


Outcome Measures
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Primary Outcome Measures :
  1. Childhood Autism Rating Scale (CARS) [ Time Frame: 5 Weeks ]
    Difference in CARS score between start and end of double-blind portion of the study


Eligibility Criteria
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Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Primary diagnosis of Autism Spectrum Disorder by DSM-IV-TR rendered by the examination and sufficient CARS-2 score to qualify as autism.
  • CARS score between 36 and 47 inclusively
  • Age between 4 and 12 years (at day of informed consent)
  • Child must suffer disrupted sleep patterns defined as a minimum of 3 nights per week of delayed onset of sleep or night-time awakenings. If these are medicated with mild sedatives or melatonin and corrected, the requirement for medication or melatonin will qualify as evidence of a sleep disorder.

Exclusion Criteria:

  • Diagnosis of Asperger's Disorder, Pervasive Developmental Disorder Not Otherwise specified
  • History of clinically significant traumatic brain injury
  • Any condition associated with increased intracranial pressure
  • Cerebral Aneurysm
  • Down's Syndrome or other chromosomal abnormality
  • EEG abnormalities that indicate seizure risk
  • Intracranial implant
  • Unstable medical condition not otherwise specified
  • Clinically significant organic disease unrelated to autism
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985308


Locations
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United States, California
Brain Treatment Center
Newport Beach, California, United States, 92660
United States, Georgia
Brain Treatment Center of Atlanta
Buford, Georgia, United States, 30518
Sponsors and Collaborators
Wave Neuroscience
Investigators
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Principal Investigator: Jeff Bradstreet, MD
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Wave Neuroscience
ClinicalTrials.gov Identifier: NCT01985308    
Other Study ID Numbers: MRT-001
First Posted: November 15, 2013    Key Record Dates
Last Update Posted: April 16, 2014
Last Verified: April 2014
Additional relevant MeSH terms:
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Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders