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

NCT02407496 | Completed

• 2 other identifiers: TNI-NAT-1R43MH099709
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

ADHD

Adults with Attention Deficit Hyperactivity Disorder (ADHD)

Other: Behavioral assessment and NAT EEG tests

Control

Healthy individuals without ADHD

Other: Behavioral assessment and NAT EEG tests

Interventions

Behavioral assessment and NAT EEG tests OTHER

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

ADHD; Control

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 greater Los Angeles area.

You may qualify if:

• 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.

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 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
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

UCLA Semel Institute

Los Angeles, California, 90095, 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

• Mark S Cohen, Ph.D.

  University of California, Los Angeles

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: March 27, 2015
• First Posted: April 3, 2015
• Study Start: June 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: September 1, 2015
• Last Updated: December 10, 2020

Record last verified: 2020-12

Locations

US (1)