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: Magnetic Resonance Therapy (MRT)-Active; Device: Magnetic Resonance Therapy (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

Description

Inclusion Criteria:

• Primary diagnosis of Autism Spectrum Disorder by Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR) rendered by the examination and sufficient Childhood Autism Rating Scale 2nd Edition (CARS-2) score to qualify as autism.
• CARS-2 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: Magnetic Resonance Therapy (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: Magnetic Resonance Therapy (MRT)-Active
Sham Comparator: Magnetic Resonance Therapy (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: Magnetic Resonance Therapy (MRT)-Sham

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Childhood Autism Rating Scale 2nd Edition (CARS2)	The Childhood Autism Rating Scale is a behavior rating scale that measures the severity of autism symptoms in children. It consists of 15 sub-domains including relating to people, adaptation to change, verbal communication, and visual response. Each sub-domain is rated between 1-4, with the total score ranging from a low of 15 to a high of 60. Scores below 30 indicate that the individual is in the non-autistic range. Scores between 30 and 36.5 indicate mild to moderate autism, and scores from 37 to 60 indicate severe autism. A higher CARS score represents more severe symptoms. In the present study, the primary outcome was numerical change in CARS score between baseline and Week 5 (end of the double-blind portion of the study). The comparison of the mean and standard deviation between groups is reported. Difference in CARS score between the baseline and week 5 (end of double-blind portion of the study). CARS value at 5 weeks minus CARS value at baseline.	5 Weeks

Collaborators and Investigators

• Sponsor: Wave Neuroscience
• Investigators: Principal Investigator: Keun-Young Kim, 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 (Estimated): November 15, 2013

Study Record Updates

• Last Update Posted (Actual): August 7, 2024
• Last Update Submitted That Met QC Criteria: July 11, 2024
• Last Verified: July 1, 2024

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

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No Identifiable Patient Data (IPD) will be shared.