ADHD
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEActive MeRT Treatment
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.
DEVICESham MeRT Treatment
A personalized biometrics-guided protocol similar to MeRT treatment that mimics magnetic EEG/EKG resonance therapy (MeRT) but does not emit active stimulation.
Sponsors
Wave Neuroscience
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Subjects and clinicians will be blind to treatment condition.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
Subjects must meet all of the following inclusion criteria to qualify for enrollment into the study: 1. College student 18-25 years of age 2. Diagnosed with ADHD using the standardized clinical interview and supported by the Pearson Quotient ADHD System and Conners Adult ADHD Rating Scales (CAARS) 3. Willing and able to adhere to the treatment schedule and all required study visits
Exclusion criteria
Subjects will be excluded from study participation if one of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pearson Quotient ADHD System | Four weeks. | Changes in Pearson Quotient ADHD System; arithmetic changes in Pearson Quotient ADHD System score between time points at baseline and end of week 4. |
| Conners Adult ADHD Rating Scales (CAARS) | Four weeks. | 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. |
| Electroencephalogram (EEG) Assessment | Four weeks. | Changes in electroencephalogram (EEG) will be assessed at baseline, week 2 and end of week 4. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rivermead Post Concussion Symptoms Questionnaire (RPQ) | Four weeks. | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Safety Outcomes assessed by Arithmetic number of Adverse Events (AEs) and Serious Adverse Events (SAEs). | Four weeks. | Arithmetic number of Adverse Events (AEs) and Serious Adverse Events (SAEs). |
Countries
United States
Outcome results
None listed