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

Wave Neuroscience

Status: Completed

Conditions: Autism Spectrum Disorder

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01985308

MRT-001

Details and patient eligibility

About

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.

Enrollment: 28 patients

Sex: All

Ages: 4 to 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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28 participants in 2 patient groups

Magnetic Resonance Therapy (MRT)-Active

Experimental group

Description:

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.

Treatment:

Device: Magnetic Resonance Therapy (MRT)-Active

Magnetic Resonance Therapy (MRT)-Sham

Sham Comparator group

Description:

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.

Treatment:

Device: Magnetic Resonance Therapy (MRT)-Sham