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

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.

Sponsors

Lead Sponsor: Wave Neuroscience

Source Wave Neuroscience
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.

Overall Status Completed
Start Date February 23, 2016
Completion Date April 17, 2019
Primary Completion Date April 17, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Pearson Quotient ADHD System Four weeks.
Conners Adult ADHD Rating Scales (CAARS) Four weeks.
Electroencephalogram (EEG) Assessment Four weeks.
Secondary Outcome
Measure Time Frame
Rivermead Post Concussion Symptoms Questionnaire (RPQ) Four weeks.
Enrollment 31
Condition
Intervention

Intervention Type: Device

Intervention Name: Active MeRT Treatment

Description: 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.

Arm Group Label: Active MeRT Treatment

Other Name: rTMS Active Stimulator

Intervention Type: Device

Intervention Name: Sham MeRT Treatment

Description: A personalized biometrics-guided protocol similar to MeRT treatment that mimics magnetic EEG/EKG resonance therapy (MeRT) but does not emit active stimulation.

Arm Group Label: Sham MeRT Treatment

Other Name: rTMS Sham Stimulator

Eligibility

Criteria:

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 25 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Charles Liu, MD, PhD Principal Investigator University of Southern California Neurorestoration Center
Location
Facility: USC Neurorestoration Center
Location Countries

United States

Verification Date

April 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 2
Arm Group

Label: Active MeRT Treatment

Type: Active Comparator

Description: Active treatment will consist of 6 seconds a minute for 30 minutes a day, 5 days a week for 4 weeks.

Label: Sham MeRT Treatment

Type: Sham Comparator

Description: 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.

Acronym MeRT-USC-009
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

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.

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description: Subjects and clinicians will be blind to treatment condition.

Source: ClinicalTrials.gov