Neurophysiological Attention Test (NAT) for Objective Assessment of Attention Deficit Hyperactivity Disorder (ADHD) (NAT-I)

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

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
• Intervention / Treatment: Other: Behavioral assessment and NAT EEG tests

Detailed Description

The purpose of this study is to develop a novel approach and software for analyzing electroencephalography (EEG) data to identify biomarkers of ADHD. Then to test the ability of this 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): 80

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Semel Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: Yes
• 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 greater Los Angeles area.

Description

Inclusion Criteria:

• Specific inclusion criteria for ADHD are:

  1. meet established DSM-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 wit the 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 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?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ADHD; Adults with Attention Deficit Hyperactivity Disorder (ADHD)	Other: Behavioral assessment and NAT EEG tests; Individuals in both groups are asked to perform standard behavioral tests and an electroencephalography (EEG) test.
Control; Healthy individuals without ADHD	Other: Behavioral assessment and NAT EEG tests; 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 Measure	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 Controls.	A single measurement is made for each individual at DAY 1 - the time of the brain wave test.

Collaborators and Investigators

• Sponsor: Think Now Incorporated
• Collaborators: National Institute of Mental Health (NIMH); University of California, Los Angeles
• Investigators: Study Director: Mark S Cohen, Ph.D., University of California, Los Angeles

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (ACTUAL): July 1, 2015
• Study Completion (ACTUAL): September 1, 2015

Study Registration Dates

• First Submitted: March 27, 2015
• First Submitted That Met QC Criteria: March 31, 2015
• First Posted (ESTIMATE): April 3, 2015

Study Record Updates

• Last Update Posted (ACTUAL): December 10, 2020
• Last Update Submitted That Met QC Criteria: December 9, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: TNI-NAT-1; R43MH099709 (NIH)