Autism Spectrum Disorder
Conditions
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.
Interventions
DEVICEMagnetic Resonance Therapy (MRT)-Active
DEVICEMagnetic Resonance Therapy (MRT)-Sham
Sponsors
Wave Neuroscience
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Childhood Autism Rating Scale 2nd Edition (CARS2) | 5 Weeks | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
MRT-Active | 14 |
| 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.
MRT-SHAM | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | MRT-Active | MRT-SHAM | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 14 Participants | 14 Participants | 28 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 7.26 years STANDARD_DEVIATION 2.53 | 7.64 years STANDARD_DEVIATION 2.4 | 7.45 years STANDARD_DEVIATION 2.43 |
| Race/Ethnicity, Customized African-American | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian/Pacific Islander | 5 Participants | 1 Participants | 6 Participants |
| Race/Ethnicity, Customized Caucasian | 8 Participants | 11 Participants | 19 Participants |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Female | 4 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 10 Participants | 13 Participants | 23 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 3 / 14 | 3 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
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.
Time frame: 5 Weeks
Population: Children diagnosed with Autism Spectrum Disorder
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MRT-Active | Childhood Autism Rating Scale 2nd Edition (CARS2) | -7.68 units on a scale | Standard Deviation 4.56 |
| MRT-SHAM | Childhood Autism Rating Scale 2nd Edition (CARS2) | -1.61 units on a scale | Standard Deviation 2.37 |
p-value: 0.0002t-test, 2 sided
Post Hoc
Child Autism Rating Scale Subdomain Item 11 (Verbal Communication) - Percent of Subjects Who Improved
Child Autism Rating Scale 2nd Edition (CARS2) consists of 15 Subdomains to rate a child's behavior, characteristics, and abilities against the expected developmental growth of a typical child. This outcome provides the percent of subjects who improved between baseline and Week 10 following all active treatment.
Time frame: Baseline until after Week 10
Population: Children diagnosed with Autism Spectrum Disorder
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MRT-Active | Child Autism Rating Scale Subdomain Item 11 (Verbal Communication) - Percent of Subjects Who Improved | 66.0 Percentage who improved |
Post Hoc
Child Autism Rating Scale Subdomain Item 7 (Visual Response) - Percent of Subjects Who Improved
Child Autism Rating Scale 2nd Edition (CARS2) consists of 15 Subdomains to rate a child's behavior, characteristics, and abilities against the expected developmental growth of a typical child. This outcome provides the percent of subjects who improved between baseline and Week 10 following all active treatment.
Time frame: Baseline until after Week 10
Population: Children diagnosed with Autism Spectrum Disorder
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| MRT-Active | Child Autism Rating Scale Subdomain Item 7 (Visual Response) - Percent of Subjects Who Improved | 71.4 percentage who improved |