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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE November 5, 2013
First Posted Date  ICMJE November 15, 2013
Last Update Posted Date April 16, 2014
Study Start Date  ICMJE November 2013
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2013)
Childhood Autism Rating Scale (CARS) [ Time Frame: 5 Weeks ]
Difference in CARS score between start and end of double-blind portion of the study
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial To Evaluate The Efficacy of Magnetic Resonant Therapy in Autism
Official Title  ICMJE A Randomized Double-Blind Sham-Controlled Trial To Evaluate The Treatment Efficacy of Magnetic Resonant Therapy in Autistic Disorder
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Autism Spectrum Disorder
Intervention  ICMJE
  • Device: MRT-Active
  • Device: MRT-SHAM
Study Arms  ICMJE
  • 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.
    Intervention: 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.
    Intervention: Device: MRT-SHAM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 15, 2014)
28
Original Estimated Enrollment  ICMJE
 (submitted: November 8, 2013)
36
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 12 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01985308
Other Study ID Numbers  ICMJE MRT-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wave Neuroscience
Study Sponsor  ICMJE Wave Neuroscience
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jeff Bradstreet, MD
PRS Account Wave Neuroscience
Verification Date April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP