A Trial To Evaluate The Efficacy of Magnetic Resonant Therapy in Autism
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ClinicalTrials.gov Identifier: NCT01985308 |
Recruitment Status :
Completed
First Posted : November 15, 2013
Last Update Posted : April 16, 2014
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Condition or disease | Intervention/treatment | Phase |
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Autism Spectrum Disorder | Device: MRT-Active Device: MRT-SHAM | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 28 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized Double-Blind Sham-Controlled Trial To Evaluate The Treatment Efficacy of Magnetic Resonant Therapy in Autistic Disorder |
Study Start Date : | November 2013 |
Actual Primary Completion Date : | April 2014 |
Actual Study Completion Date : | April 2014 |

Arm | Intervention/treatment |
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Experimental: 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.
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Device: MRT-Active |
Sham Comparator: 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.
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Device: MRT-SHAM |
- Childhood Autism Rating Scale (CARS) [ Time Frame: 5 Weeks ]Difference in CARS score between start and end of double-blind portion of the study

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Ages Eligible for Study: | 4 Years to 12 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Primary diagnosis of Autism Spectrum Disorder by DSM-IV-TR rendered by the examination and sufficient CARS-2 score to qualify as autism.
- CARS 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01985308
United States, California | |
Brain Treatment Center | |
Newport Beach, California, United States, 92660 | |
United States, Georgia | |
Brain Treatment Center of Atlanta | |
Buford, Georgia, United States, 30518 |
Principal Investigator: | Jeff Bradstreet, MD |
Responsible Party: | Wave Neuroscience |
ClinicalTrials.gov Identifier: | NCT01985308 |
Other Study ID Numbers: |
MRT-001 |
First Posted: | November 15, 2013 Key Record Dates |
Last Update Posted: | April 16, 2014 |
Last Verified: | April 2014 |
Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders |