An interventional study of Active MeRT Treatment and Sham MeRT Treatment in ADHD, sponsored by Wave Neuroscience. Completed at 1 site in United States. Open to participants aged 18 Years to 25 Years. Per ClinicalTrials.gov, last updated 2019-04-19.
Sponsored by Wave Neuroscience · Not applicable, Interventional, and Treatment
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.
1,547 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 254 are open to participants now.
This study's enrollment of 31 is below the median of 71 across 1,233 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Wave Neuroscience is the lead sponsor of 11 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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:
Active treatment will consist of 6 seconds a minute for 30 minutes a day, 5 days a week for 4 weeks.
Device: Active MeRT Treatment
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.
Device: Sham 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.
Also known as: rTMS Active Stimulator
A personalized biometrics-guided protocol similar to MeRT treatment that mimics magnetic EEG/EKG resonance therapy (MeRT) but does not emit active stimulation.
Also known as: rTMS Sham Stimulator
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.
Time frame: 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.
Time frame: Four weeks.
Electroencephalogram (EEG) Assessment
Changes in electroencephalogram (EEG) will be assessed at baseline, week 2 and end of week 4.
Time frame: Four weeks.
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.
Time frame: Four weeks.
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).
Time frame: Four weeks.
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2019. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Attention Deficit Disorder with Hyperactivity →
Wave Neuroscience