Back to resultsA Trial To Evaluate The Efficacy of Magnetic Resonant Therapy in Autism
Primary Purpose
Autism Spectrum Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRT-Active
MRT-SHAM
Sponsored by
About this trial
This is an interventional treatment trial for Autism Spectrum Disorder
Eligibility 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
Sites / Locations
- Brain Treatment Center
- Brain Treatment Center of Atlanta
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
MRT-Active
MRT-SHAM
Arm 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.
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.
Outcomes
Primary Outcome Measures
Childhood Autism Rating Scale (CARS)
Difference in CARS score between start and end of double-blind portion of the study
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01985308
Brief Title
A Trial To Evaluate The Efficacy of Magnetic Resonant Therapy in Autism
Official Title
A Randomized Double-Blind Sham-Controlled Trial To Evaluate The Treatment Efficacy of Magnetic Resonant Therapy in Autistic Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wave Neuroscience
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MRT-Active
Arm Type
Experimental
Arm 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.
Arm Title
MRT-SHAM
Arm Type
Sham Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
MRT-Active
Intervention Type
Device
Intervention Name(s)
MRT-SHAM
Primary Outcome Measure Information:
Title
Childhood Autism Rating Scale (CARS)
Description
Difference in CARS score between start and end of double-blind portion of the study
Time Frame
5 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Bradstreet, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brain Treatment Center
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
Country
United States
Facility Name
Brain Treatment Center of Atlanta
City
Buford
State/Province
Georgia
ZIP/Postal Code
30518
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Trial To Evaluate The Efficacy of Magnetic Resonant Therapy in Autism
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