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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Magnetic Resonance Therapy (MRT)-Active | Experimental | 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 Resonance Therapy (MRT)-Sham | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Magnetic Resonance Therapy (MRT)-Active | Device |
| ||
| Magnetic Resonance Therapy (MRT)-Sham |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Keun-Young Kim, MD | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brain Treatment Center | Newport Beach | California | 92660 | United States | ||
| Brain Treatment Center of Atlanta |
No Identifiable Patient Data (IPD) will be shared.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | MRT-SHAM |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Children diagnosed with Autism Spectrum Disorder | Posted | Mean | Standard Deviation | units on a scale | 5 Weeks |
|
Adverse events were collected for 12 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal upset | Gastrointestinal disorders | SNOMED CT | Systematic Assessment |
The small number of patients involved in the study is its primary limitation. One missed aspect was performing a passive cohort EEG analysis of 28 children with autism of the same age, gender and social status who did not undergo MRT treatment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mazaya Soundra, Clinical Trials Manager | Wave Neuroscience, Inc. | 9492292869 | mazaya@waveneuro.com |
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| ID | Term |
|---|---|
| D000067877 | Autism Spectrum Disorder |
| ID | Term |
|---|---|
| D002659 | Child Development Disorders, Pervasive |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| Device |
|
| Buford |
| Georgia |
| 30518 |
| United States |
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
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Description |
|---|
| OG000 | 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 |
| OG001 | 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 |
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| 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. | Children diagnosed with Autism Spectrum Disorder | Posted | Number | percentage who improved | Baseline until after Week 10 |
|
|
|
| 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. | Children diagnosed with Autism Spectrum Disorder | Posted | Number | Percentage who improved | Baseline until after Week 10 |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 3 |
| 14 |
| EG001 | 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 | 0 | 14 | 0 | 14 | 3 | 14 |
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