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

Completed

• Conditions: Attention Deficit Hyperactivity Disorder
• Interventions: Other: NAT electroencephalography (EEG) test

• Registration Number: NCT02756286
• Lead Sponsor: Think Now Incorporated

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2015-11-12
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-04-29
• Study Start: 2017-01-01
• Primary Completion: 2018-06-01
• Study Completion: 2018-07-05
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-17
• Last Update Posted: 2018-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 258

Inclusion Criteria

Specific inclusion criteria for ADHD are:

1. 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
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 with the Mini International Neuropsychiatric Interview (MINI).
4. able in the opinion of the investigator to complete all required study procedures.

Exclusion Criteria

Exclusion criteria for both groups are:

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 central nervous system (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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ADHD: Adults with ADHD	NAT electroencephalography (EEG) test	NAT electroencephalography (EEG) test
Controls: Healthy adults without ADHD	NAT electroencephalography (EEG) test	NAT electroencephalography (EEG) test

Primary Outcome Measures

Name	Time	Method
NAT Slow Fluctuation Test and Retest to assess change for Test Replicability	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.

Trial Locations

Locations (3)

UCLA Semel Institute; 🇺🇸 Los Angeles, California, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

University of California Berkeley; 🇺🇸 Berkeley, California, United States