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OpenTrials
Completed

NCT Number: NCT02407496

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

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).

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UCLA Semel Institute

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Specific inclusion criteria for ADHD are:
  • 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
  • Clinical Global Impression-Severity (CGI-S) score ≥ 4 for ADHD
  • 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
  • able in the opinion of the investigator to complete all required study procedures.

Exclusion criteria

  • Exclusion criteria for both groups are:
  • History of diagnosis of childhood disorder other than ADHD (e.g. autism, dyslexia)
  • history of any general medical condition likely to require chronic use of medication with identified CNS effects suspected to alter cognitive performance
  • history of seizure disorder, brain tumor, other major neurological disorder or head injury resulting in loss of consciousness
  • serious oxygen deprivation
  • current psychopathology requiring ongoing treatment with antipsychotic medications, mood stabilizers, benzodiazepines, or anticonvulsants
  • current untreated psychopathology which is rated to be primary in terms of severity (greater than ADHD severity)
  • current treatment with guanfacine.

Treatment and study plan

Behavioral assessment and NAT EEG tests

Other

Individuals in both groups are asked to perform standard behavioral tests and an electroencephalography (EEG) test.

Primary outcomes

  1. NAT Slow Fluctuation Measure

    Time frame: A single measurement is made for each individual at DAY 1 - the time of the brain wave test.

    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.

Sponsors and collaborators

Lead sponsor

Think Now Incorporated

Industry

Collaborators

  • National Institute of Mental Health (NIMH)
  • University of California, Los Angeles

Registry information

Acronym: NAT-I

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 3, 2015
Registry last updated
Dec 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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