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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)

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ClinicalTrials.gov Identifier: NCT03066505
Recruitment Status : Completed
First Posted : February 28, 2017
Last Update Posted : April 19, 2019
Sponsor:
Information provided by (Responsible Party):
Wave Neuroscience

Study Description
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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.

Condition or disease Intervention/treatment Phase
ADHD Device: Active MeRT Treatment Device: Sham MeRT Treatment Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Subjects and clinicians will be blind to treatment condition.
Primary Purpose: Treatment
Official Title: 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.
Actual Study Start Date : February 23, 2016
Actual Primary Completion Date : April 17, 2019
Actual Study Completion Date : April 17, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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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 Name: 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 Name: rTMS Sham Stimulator


Outcome Measures
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Primary Outcome Measures :
  1. Pearson Quotient ADHD System [ Time Frame: 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.

  2. Conners Adult ADHD Rating Scales (CAARS) [ Time Frame: 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.

  3. Electroencephalogram (EEG) Assessment [ Time Frame: Four weeks. ]
    Changes in electroencephalogram (EEG) will be assessed at baseline, week 2 and end of week 4.


Secondary Outcome Measures :
  1. Rivermead Post Concussion Symptoms Questionnaire (RPQ) [ Time Frame: 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 Outcome Measures:
  1. Safety Outcomes assessed by Arithmetic number of Adverse Events (AEs) and Serious Adverse Events (SAEs). [ Time Frame: Four weeks. ]
    Arithmetic number of Adverse Events (AEs) and Serious Adverse Events (SAEs).


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066505


Locations
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United States, California
USC Neurorestoration Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
Wave Neuroscience
Investigators
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Principal Investigator: Charles Liu, MD, PhD University of Southern California Neurorestoration Center
More Information
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Responsible Party: Wave Neuroscience
ClinicalTrials.gov Identifier: NCT03066505    
Other Study ID Numbers: MeRT-USC-009
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: April 19, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No