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

Not Applicable

Completed

• Conditions: ADHD
• Interventions: Device: Sham MeRT Treatment; Device: Active MeRT Treatment

• Registration Number: NCT03066505
• Lead Sponsor: 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.

Study Timeline

• Study Start: 2016-02-23
• Study First Submitted: 2017-02-23
• Study First Submitted QC: 2017-02-27
• Study First Posted: 2017-02-28
• Status Verified: 2019-04
• Primary Completion: 2019-04-17
• Study Completion: 2019-04-17
• Last Update Submitted: 2019-04-17
• Last Update Posted: 2019-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham MeRT Treatment	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.
Active MeRT Treatment	Active MeRT Treatment	Active treatment will consist of 6 seconds a minute for 30 minutes a day, 5 days a week for 4 weeks.

Primary Outcome Measures

Name	Time	Method
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.
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.
Electroencephalogram (EEG) Assessment	Four weeks.	Changes in electroencephalogram (EEG) will be assessed at baseline, week 2 and end of week 4.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

USC Neurorestoration Center; 🇺🇸 Los Angeles, California, United States