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Completed

NCT Number: NCT02756286

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

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.

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California Berkeley, Berkeley, California, United States

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About this study

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.

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 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
  • 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 with the Mini International Neuropsychiatric Interview (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 central nervous system (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

NAT electroencephalography (EEG) test

Other

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

Primary outcomes

  1. NAT Slow Fluctuation Test and Retest to assess change for Test Replicability

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

Think Now Incorporated

Industry

Collaborators

  • National Institute of Mental Health (NIMH)
  • Oregon Health and Science University
  • University of California, Berkeley
  • University of California, Los Angeles

Registry information

Acronym: NAT-II

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 29, 2016
Registry last updated
Sep 19, 2018

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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