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

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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brain Treatment Center, Newport Beach, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Therapy (MRT)-Active

Device

Magnetic Resonance Therapy (MRT)-Sham

Device

Primary outcomes

Childhood Autism Rating Scale 2nd Edition (CARS2)

Time frame: 5 Weeks

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.

Sponsors and collaborators

Lead sponsor

Wave Neuroscience

Industry

Registry information

Official study title

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

Important dates

Study start: 2013
Primary completion: 2014
Study completion: 2014
First posted: Nov 15, 2013
Registry last updated: Aug 7, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed