IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. 
A Trial To Evaluate The Efficacy of Magnetic Resonant Therapy in Autism
This study has been completed.
Sponsor:
Newport Brain Research Laboratory
Information provided by (Responsible Party):
Newport Brain Research Laboratory
ClinicalTrials.gov Identifier:
NCT01985308
First received: November 5, 2013
Last updated: April 15, 2014
Last verified: April 2014
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
| Autism Spectrum Disorder | Device: MRT-Active Device: MRT-SHAM |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
autism spectrum disorder
MedlinePlus related topics:
Autism Spectrum Disorder
U.S. FDA Resources
Further study details as provided by Newport Brain Research Laboratory:
Primary Outcome Measures:
- Childhood Autism Rating Scale (CARS) [ Time Frame: 5 Weeks ]Difference in CARS score between start and end of double-blind portion of the study
| Enrollment: | 28 |
| Study Start Date: | November 2013 |
| Study Completion Date: | April 2014 |
| Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
|
Device: MRT-SHAM |
Eligibility| Ages Eligible for Study: | 4 Years to 12 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01985308
Please refer to this study by its ClinicalTrials.gov identifier: NCT01985308
Locations
| 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 | |
Sponsors and Collaborators
Newport Brain Research Laboratory
Investigators
| Principal Investigator: | Jeff Bradstreet, MD |
More Information
| Responsible Party: | Newport Brain Research Laboratory |
| ClinicalTrials.gov Identifier: | NCT01985308 History of Changes |
| Other Study ID Numbers: |
MRT-001 |
| Study First Received: | November 5, 2013 |
| Last Updated: | April 15, 2014 |
Additional relevant MeSH terms:
|
Autism Spectrum Disorder Child Development Disorders, Pervasive Neurodevelopmental Disorders Mental Disorders |
ClinicalTrials.gov processed this record on July 24, 2017