Neurophysiological Attention Test (NAT) for Objective Assessment of Adult ADHD (NAT-II)

The purpose of this study is to refine a new assessment tool for Attention Deficit/Hyperactivity Disorder (ADHD) and then to test its validity (i.e. ability to discriminate between individuals with ADHD and healthy controls.

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Other: NAT electroencephalography (EEG) test

Detailed Description

The purpose of this study is to build upon the success the novel approach and software for analyzing electroencephalography (EEG) data to identify biomarkers of ADHD in adults by further refining the method. Then to test the ability of this new assessment tool to differentiate between adults with ADHD and healthy controls by comparing the classification accuracy of the metrics from the new tool to the classification accuracy of existing behavioral tests for ADHD.

• Study Type: Observational
• Enrollment (Actual): 258

Contacts and Locations

Study Locations

• United States
  • California
    • Berkeley, California, United States, 94720
      • University of California Berkeley
    • Los Angeles, California, United States, 90095
      • UCLA Semel Institute
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with Attention Deficit Hyperactivity Disorder (ADHD) from local clinics, clinicians, ADHD community resources in the area of each of the three participating Universities (UCLA, UCB, OHSU)

Description

Inclusion Criteria:

Specific inclusion criteria for ADHD are:

1. meet established Diagnositic and Statistical Manual-5 criteria for ADHD predominately inattentive or combined subtype with clinically significant levels of impairment, diagnosed by structured clinical interview, the Mini International Neuropsychiatric Interview, and corroborating information
2. Clinical Global Impression-Severity (CGI-S) score ≥ 4 for ADHD
3. no lifetime history of DSM-5 bipolar disorder, psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, substance abuse, or substance dependence (except nicotine) as assessed with the Mini International Neuropsychiatric Interview (MINI).
4. able in the opinion of the investigator to complete all required study procedures.

Exclusion Criteria:

Exclusion criteria for both groups are:

1. History of diagnosis of childhood disorder other than ADHD (e.g. autism, dyslexia)
2. history of any general medical condition likely to require chronic use of medication with identified central nervous system (CNS) effects suspected to alter cognitive performance
3. history of seizure disorder, brain tumor, other major neurological disorder or head injury resulting in loss of consciousness
4. serious oxygen deprivation
5. current psychopathology requiring ongoing treatment with antipsychotic medications, mood stabilizers, benzodiazepines, or anticonvulsants
6. current untreated psychopathology which is rated to be primary in terms of severity (greater than ADHD severity)
7. current treatment with guanfacine.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ADHD: Adults with ADHD; NAT electroencephalography (EEG) test	Other: NAT electroencephalography (EEG) test; Individuals in both groups are asked to perform standard behavioral tests and an electroencephalography (EEG) test.
Controls: Healthy adults without ADHD; NAT electroencephalography (EEG) test	Other: NAT electroencephalography (EEG) test; Individuals in both groups are asked to perform standard behavioral tests and an electroencephalography (EEG) test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NAT Slow Fluctuation Test and Retest to assess change for Test Replicability	The NAT EEG test simultaneously generates 2 EEG values and 1 behavioral value that are used together as an assessment metric for ADHD. This is a one-time measure to assess its magnitude in ADHD vs Control.	A single measurement is made for each individual at DAY 1 - the time of the brain wave (EEG) test; and a single measure is made again in each individual at least 30 days later (DAY 2) to identify any differences, to assess replicability of the measure.

Collaborators and Investigators

• Sponsor: Think Now Incorporated
• Collaborators: National Institute of Mental Health (NIMH); University of California, Berkeley; University of California, Los Angeles; Oregon Health and Science University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): July 5, 2018

Study Registration Dates

• First Submitted: November 12, 2015
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (Estimate): April 29, 2016

Study Record Updates

• Last Update Posted (Actual): September 19, 2018
• Last Update Submitted That Met QC Criteria: September 17, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Keywords: Attention; Electroencephalography
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: TNI-NAT-II; R44MH099709 (U.S. NIH Grant/Contract)