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

A Randomized Double-Blind Sham-Controlled Trial To Evaluate The Treatment Efficacy of Magnetic Resonant Therapy in Autistic Disorder

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Device: MRT-Active; Device: MRT-SHAM

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92660
      • Brain Treatment Center
  • Georgia
    • Buford, Georgia, United States, 30518
      • Brain Treatment Center of Atlanta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Childhood Autism Rating Scale (CARS)	Difference in CARS score between start and end of double-blind portion of the study	5 Weeks

Collaborators and Investigators

• Sponsor: Wave Neuroscience
• Investigators: Principal Investigator: Jeff Bradstreet, MD

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: November 5, 2013
• First Submitted That Met QC Criteria: November 8, 2013
• First Posted (Estimate): November 15, 2013

Study Record Updates

• Last Update Posted (Estimate): April 16, 2014
• Last Update Submitted That Met QC Criteria: April 15, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autism Spectrum Disorder
• Other Study ID Numbers: MRT-001