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

NCT ID: NCT02407496

Last Updated: 2020-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-06-30

Study Completion Date

2015-09-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Attention Deficit Hyperactivity Disorder (ADHD)

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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ADHD

Adults with Attention Deficit Hyperactivity Disorder (ADHD)

Behavioral assessment and NAT EEG tests

Intervention Type OTHER

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

Control

Healthy individuals without ADHD

Behavioral assessment and NAT EEG tests

Intervention Type OTHER

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

Interventions

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Behavioral assessment and NAT EEG tests

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, Los Angeles

OTHER

Sponsor Role collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Think Now Incorporated

INDUSTRY

Sponsor Role lead

Responsible Party

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Gregory Simpson, Ph.D.

Chief Scientific Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gregory V Simpson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Think Now, Inc.

Mark S Cohen, Ph.D.

Role: STUDY_DIRECTOR

University of California, Los Angeles

Locations

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UCLA Semel Institute

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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R43MH099709

Identifier Type: NIH

Identifier Source: secondary_id

View Link

TNI-NAT-1

Identifier Type: -

Identifier Source: org_study_id