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This pilot study is a randomized, double-blind, sham-controlled study designed to evaluate the efficacy of Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) in college students with ADHD. A total of 40 subjects will be treated.
This pilot study is a randomized, double-blind, sham-controlled study designed to evaluate the efficacy of Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) in college students with ADHD. A total of 40 subjects will be treated.
Twenty (20) subjects will receive active treatment with MeRT and the other 20 with sham. Subjects in each study group will be treated 30 min a day, 5 days a week for 4 weeks. This is known as Phase 1. During this study period, subjects and clinicians will be blind to treatment condition.
Subjects will be recruited from a flyer describing the study. The flyer will be posted at the Kortschak Center for Learning and Creativity, the McKay Center, and through Student Counseling Services in the Engemann Student Health Center. In addition, students who have been diagnosed with ADHD and have been seen at one of these facilities for ADHD may be provided contact information for the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active MeRT Treatment | Active Comparator | Active treatment will consist of 6 seconds a minute for 30 minutes a day, 5 days a week for 4 weeks. |
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| Sham MeRT Treatment | Sham Comparator | Sham treatment will consist of 6 seconds a minute for 30 minutes a day, 5 days a week for 4 weeks. Sham treatment mimicks same noise and sensation of active treatment but provides no treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Active MeRT Treatment | Device | A personalized biometrics-guided protocol known as magnetic EEG/EKG resonance therapy (MeRT) treatment that is tailored specifically to each patient's higher harmonic frequency of heart rate, which is nearest to the characteristic frequency of alpha EEG frequency. |
| Measure | Description | Time Frame |
|---|---|---|
| Pearson Quotient ADHD System | Changes in Pearson Quotient ADHD System; arithmetic changes in Pearson Quotient ADHD System score between time points at baseline and end of week 4. | Four weeks. |
| Conners Adult ADHD Rating Scales (CAARS) | Changes in Conners Adult ADHD Rating Scales (CAARS) ; arithmetic changes in Conners Adult ADHD Rating Scales (CAARS) total score between time points at baseline and end of week 4. | Four weeks. |
| Electroencephalogram (EEG) Assessment | Changes in electroencephalogram (EEG) will be assessed at baseline, week 2 and end of week 4. | Four weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Rivermead Post Concussion Symptoms Questionnaire (RPQ) | Changes in Rivermead Post Concussion Symptoms Questionnaire (RPQ); arithmetic changes in Rivermead Post-Concussion Symptoms Questionnaire (RPQ-16) total score between time points at baseline and end of week 4. | Four weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Outcomes assessed by Arithmetic number of Adverse Events (AEs) and Serious Adverse Events (SAEs). | Arithmetic number of Adverse Events (AEs) and Serious Adverse Events (SAEs). | Four weeks. |
Inclusion Criteria:
Subjects must meet all of the following inclusion criteria to qualify for enrollment into the study:
Exclusion Criteria:
Subjects will be excluded from study participation if one of the following exclusion criteria applies:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Liu, MD, PhD | University of Southern California Neurorestoration Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Neurorestoration Center | Los Angeles | California | 90033 | United States |
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Sixteen (16) subjects will receive active treatment with MeRT and the other 15 with sham. Subjects in each study group will be treated 30 min a day, 5 days a week for 4 weeks.
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Subjects and clinicians will be blind to treatment condition.
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| Sham MeRT Treatment | Device | A personalized biometrics-guided protocol similar to MeRT treatment that mimics magnetic EEG/EKG resonance therapy (MeRT) but does not emit active stimulation. |
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| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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