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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Newport Brain Research Laboratory
ClinicalTrials.gov Identifier:
NCT01985308
First received: November 5, 2013
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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 Intervention
Autism Spectrum Disorder
Device: MRT-Active
Device: MRT-SHAM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Newport Brain Research Laboratory:

Primary Outcome Measures:
  • Childhood Autism Rating Scale (CARS) [ Time Frame: 5 Weeks ] [ Designated as safety issue: No ]
    Difference in CARS score between start and end of double-blind portion of the study


Enrollment: 28
Study Start Date: November 2013
Study Completion Date: April 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   4 Years to 12 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01985308

Locations
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
Newport Brain Research Laboratory
Investigators
Principal Investigator: Jeff Bradstreet, MD
  More Information

No publications provided

Responsible Party: Newport Brain Research Laboratory
ClinicalTrials.gov Identifier: NCT01985308     History of Changes
Other Study ID Numbers: MRT-001
Study First Received: November 5, 2013
Last Updated: April 15, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Autistic Disorder
Child Development Disorders, Pervasive
Mental Disorders Diagnosed in Childhood
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014