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

Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial

— NAT-I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02407496
• Other study ID #: TNI-NAT-1
• Secondary ID: R43MH099709
• Status: Completed
• Start date: June 2014
• Est. completion date: September 2015

Study information

• Verified date: December 2020
• Source: Think Now Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder with Hyperactivity
• Attention Deficit Hyperactivity Disorder (ADHD)
• Hyperkinesis

Intervention

Other:
• Behavioral assessment and NAT EEG tests
Individuals in both groups are asked to perform standard behavioral tests and an electroencephalography (EEG) test.

Locations

Country	Name	City	State
United States	UCLA Semel Institute	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
Think Now Incorporated	National Institute of Mental Health (NIMH), University of California, Los Angeles

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.