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

Completed

• Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
• Interventions: Other: Behavioral assessment and NAT EEG tests

• Registration Number: NCT02407496
• Lead Sponsor: Think Now Incorporated

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).

Detailed Description

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.

Study Timeline

• Study Start: 2014-06
• Study First Submitted: 2015-03-27
• Study First Submitted QC: 2015-03-31
• Study First Posted: 2015-04-03
• Primary Completion: 2015-07
• Study Completion: 2015-09
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-09
• Last Update Posted: 2020-12-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Specific inclusion criteria for ADHD are:

  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

• 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 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
Control	Behavioral assessment and NAT EEG tests	Healthy individuals without ADHD
ADHD	Behavioral assessment and NAT EEG tests	Adults with Attention Deficit Hyperactivity Disorder (ADHD)

Primary Outcome Measures

Name	Time	Method
NAT Slow Fluctuation Measure	A single measurement is made for each individual at DAY 1 - the time of the brain wave test.	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.

Trial Locations

Locations (1)

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