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

Think Now Incorporated

Status

Completed

Conditions

Attention Deficit Hyperactivity Disorder (ADHD)

Treatments

Other: Behavioral assessment and NAT EEG tests

Study type

Observational

Funder types

Other

Industry

NIH

Identifiers

NCT02407496

TNI-NAT-1

R43MH099709 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment

80 patients

Sex

All

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

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.