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

Not Applicable

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Device: Magnetic Resonance Therapy (MRT)-Sham; Device: Magnetic Resonance Therapy (MRT)-Active

• Registration Number: NCT01985308
• Lead Sponsor: Wave Neuroscience

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 available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-05
• Study First Submitted QC: 2013-11-08
• Study First Posted: 2013-11-15
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Results First Submitted: 2017-05-12
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-11
• Last Update Submitted: 2024-07-11
• Results First Posted: 2024-08-07
• Last Update Posted: 2024-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Magnetic Resonance Therapy (MRT)-Sham	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.
Magnetic Resonance Therapy (MRT)-Active	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.

Primary Outcome Measures

Name	Time	Method
Childhood Autism Rating Scale 2nd Edition (CARS2)	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.

Trial Locations

Locations (2)

Brain Treatment Center; 🇺🇸 Newport Beach, California, United States

Brain Treatment Center of Atlanta; 🇺🇸 Buford, Georgia, United States