A Randomized, Double-blind, Sham-controlled Pilot Study to Evaluate the Treatment Efficacy of Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) in College Students With ADHD (MeRT-USC-009)

A Randomized, Double-blind, Sham-controlled Pilot Study to Evaluate the Treatment Efficacy of Magnetic EEG/ECG-Guided Resonance Therapy (MeRT) in College Students With Attention Deficit Hyperactivity Disorder.

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.

Study Overview

• Status: Completed
• Conditions: ADHD
• Intervention / Treatment: Device: Active MeRT Treatment; Device: Sham MeRT Treatment

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90033
      • USC Neurorestoration Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 exclusion criteria applies:

1. Pregnant or trying to become pregnant; negative urine pregnancy test at screening will be required of females of child-bearing potential
2. Any antipsychotic or anticonvulsant medication.
3. Any type of rTMS treatment within 3 months prior to the screening visit
4. Intracranial implant (e.g., aneurysm clips, shunts, stimulators, cochlear implants, stents, or electrodes) or any other metal object within or near the head, excluding the mouth, which cannot be safely removed
5. Any condition which in the judgment of the investigator would prevent the subject from completing the study
6. Any seizure history within the past 10 years
7. EEG abnormalities including indications of risk of seizure, i.e., abnormal focal or general slowing in spikes during the EEG recording
8. Unstable medical conditions such as uncontrolled endocrine, hepatic, cardiac, pulmonary and/or renal disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active MeRT Treatment; 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; 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.; Other Names: rTMS Active Stimulator
Sham Comparator: Sham 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 similar to MeRT treatment that mimics magnetic EEG/EKG resonance therapy (MeRT) but does not emit active stimulation.; Other Names: rTMS Sham Stimulator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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.

Other Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Wave Neuroscience
• Investigators: Principal Investigator: Charles Liu, MD, PhD, University of Southern California Neurorestoration Center

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2016
• Primary Completion (Actual): April 17, 2019
• Study Completion (Actual): April 17, 2019

Study Registration Dates

• First Submitted: February 23, 2017
• First Submitted That Met QC Criteria: February 27, 2017
• First Posted (Actual): February 28, 2017

Study Record Updates

• Last Update Posted (Actual): April 19, 2019
• Last Update Submitted That Met QC Criteria: April 17, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: MeRT-USC-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No