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

NCT03066505 | Completed FDA Device

• 1 other identifier: MeRT-USC-009
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

ADHD

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Rivermead Post Concussion Symptoms Questionnaire (RPQ)

  Four weeks.

Other Outcomes (1)

• Safety Outcomes assessed by Arithmetic number of Adverse Events (AEs) and Serious Adverse Events (SAEs).

  Four weeks.

Study Arms (2)

Active MeRT Treatment

ACTIVE COMPARATOR

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

Sham MeRT Treatment

SHAM COMPARATOR

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

Interventions

Active MeRT Treatment DEVICE

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.

Also known as: rTMS Active Stimulator

Active MeRT Treatment

Sham MeRT Treatment DEVICE

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

Also known as: rTMS Sham Stimulator

Sham MeRT Treatment

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• College student 18-25 years of age
• Diagnosed with ADHD using the standardized clinical interview and supported by the Pearson Quotient ADHD System and Conners Adult ADHD Rating Scales (CAARS)
• Willing and able to adhere to the treatment schedule and all required study visits

You may not qualify if:

• Pregnant or trying to become pregnant; negative urine pregnancy test at screening will be required of females of child-bearing potential
• Any antipsychotic or anticonvulsant medication.
• Any type of rTMS treatment within 3 months prior to the screening visit
• 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
• Any condition which in the judgment of the investigator would prevent the subject from completing the study
• Any seizure history within the past 10 years
• EEG abnormalities including indications of risk of seizure, i.e., abnormal focal or general slowing in spikes during the EEG recording
• Unstable medical conditions such as uncontrolled endocrine, hepatic, cardiac, pulmonary and/or renal disorders.

Sponsors & Collaborators

• Wave Neuroscience: lead

Study Sites (1)

USC Neurorestoration Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Charles Liu, MD, PhD

  University of Southern California Neurorestoration Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Subjects and clinicians will be blind to treatment condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 23, 2017
• First Posted: February 28, 2017
• Study Start: February 23, 2016
• Primary Completion: April 17, 2019
• Study Completion: April 17, 2019
• Last Updated: April 19, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)