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

NCT01985308 | Completed Results DMC

• 1 other identifier: MRT-001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 2

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.

Conditions

Autism Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Magnetic Resonance Therapy (MRT)-Active

EXPERIMENTAL

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

Magnetic Resonance Therapy (MRT)-Sham

SHAM COMPARATOR

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

Interventions

Magnetic Resonance Therapy (MRT)-Active DEVICE

Magnetic Resonance Therapy (MRT)-Active

Magnetic Resonance Therapy (MRT)-Sham DEVICE

Magnetic Resonance Therapy (MRT)-Sham

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wave Neuroscience: lead

Study Sites (2)

Brain Treatment Center

Newport Beach, California, 92660, United States

Location

Brain Treatment Center of Atlanta

Buford, Georgia, 30518, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Limitations and Caveats

The small number of patients involved in the study is its primary limitation. One missed aspect was performing a passive cohort EEG analysis of 28 children with autism of the same age, gender and social status who did not undergo MRT treatment.

Results Point of Contact

• Title: Mazaya Soundra, Clinical Trials Manager
• Organization: Wave Neuroscience, Inc.

mazaya@waveneuro.com

9492292869

Study Officials

• Keun-Young Kim, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2013
• First Posted: November 15, 2013
• Study Start: November 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: August 7, 2024
• Results First Posted: August 7, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)