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.
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
Sponsors
Source
Wave Neuroscience
Oversight Info
Has Dmc
No
Is Fda Regulated Device
Yes
Is Unapproved Device
No
Is Us Export
No
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
2016-02-23
Completion Date
2019-04-17
Primary Completion Date
2019-04-17
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
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
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 Los Angeles California 90033 United States |
Location Countries
Country
United States
Verification Date
2019-04-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Has Expanded Access
No
Number Of Arms
2
Arm Group
Arm Group Label
Active MeRT Treatment
Arm Group 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.
Arm Group Label
Sham MeRT Treatment
Arm Group 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.
Firstreceived Results Date
N/A
Acronym
MeRT-USC-009
Other Outcome
Measure
Safety Outcomes assessed by Arithmetic number of Adverse Events (AEs) and Serious Adverse Events (SAEs).
Time Frame
Four weeks.
Description
Arithmetic number of Adverse Events (AEs) and Serious Adverse Events (SAEs).
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
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.
Study First Submitted
February 23, 2017
Study First Submitted Qc
February 27, 2017
Study First Posted
February 28, 2017
Last Update Submitted
April 17, 2019
Last Update Submitted Qc
April 17, 2019
Last Update Posted
April 19, 2019
ClinicalTrials.gov processed this data on December 10, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.