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

NCT02756286 | Completed

• 2 other identifiers: TNI-NAT-IIR44MH099709
• Study Type: observational
• Target: 258
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

Electroencephalography; Attention

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

ADHD: Adults with ADHD

NAT electroencephalography (EEG) test

Other: NAT electroencephalography (EEG) test

Controls: Healthy adults without ADHD

NAT electroencephalography (EEG) test

Other: NAT electroencephalography (EEG) test

Interventions

NAT electroencephalography (EEG) test OTHER

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

ADHD: Adults with ADHD; Controls: Healthy adults without ADHD

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (3)

University of California Berkeley

Berkeley, California, 94720, United States

Location

UCLA Semel Institute

Los Angeles, California, 90095, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, 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

• Gregory V Simpson, Ph.D.

  Think Now, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Founder and Chief Scientific Officer

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: April 29, 2016
• Study Start: January 1, 2017
• Primary Completion: June 1, 2018
• Study Completion: July 5, 2018
• Last Updated: September 19, 2018

Record last verified: 2018-09

Locations

US (3)