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

NCT ID: NCT01985308

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-04-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Magnetic Resonance Therapy (MRT)-Active

Intervention Type: DEVICE

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.

Group Type: SHAM_COMPARATOR

Magnetic Resonance Therapy (MRT)-Sham

Intervention Type: DEVICE

Interventions

Magnetic Resonance Therapy (MRT)-Active

Intervention Type: DEVICE

Magnetic Resonance Therapy (MRT)-Sham

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Wave Neuroscience

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Keun-Young Kim, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

Brain Treatment Center

Newport Beach, California, United States

Brain Treatment Center of Atlanta

Buford, Georgia, United States

Countries

United States

Other Identifiers

MRT-001

Identifier Type: -

Identifier Source: org_study_id