NeuroLex EEG-Based ADHD Assessment Aid, Pivotal Study

The study will evaluate the effectiveness of a standardized EEG method with the intended clinical users in the intended clinical settings with the intended population (patients who would typically receive a clinician's evaluation for ADHD). Multiple sites will be examined to provide a sample of patients across numerous communities with different demographics. The goal is to evaluate if the predictive accuracy of EEG will not be inferior to that of a widely-used and extensively validated ADHD scale in the prediction of ADHD in the intended use population as evaluated by Best Estimate Diagnosis.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Harmonex, Dothan, Alabama, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject willing to voluntarily participate in a research study that includes EEG collection and analysis.
Family/patient seeking comprehensive clinical evaluation for attention and/or behavior concerns.
Male or female at least 6 years of age and who will not be over 17.99 years of age upon admission to study.
Willing to stop any and all current psychiatric medications prior to or by entry into study.
Subject and parent (or legal representative) of an educational level and degree of understanding sufficient to communicate suitably with the investigator, rater and study coordinator.

Exclusion criteria

Previous diagnosis of mental retardation. IQ < 70 by previous records.
History of seizure disorder or of EEG abnormalities. On anticonvulsants for seizure control.
Metal plate or metal device in the head.
Suicide ideation or gesture and/or homicidal ideation or gesture.
Concomitant medications during participation in a research study. No prescription or nonprescription medications with psychoactive properties that may affect EEG (such as over-the-counter dietary supplements, pseudoephedrine, or phenylpropanolamine). No antipsychotics, no psychostimulants, no antidepressants. Washout of at least one week or longer depending on the medication and clinician's judgment. Medication used for medical reasons must be cleared by research staff with consideration of known effects on EEG.
Known serious medical problems (cardiovascular, hematological, liver, seizure disorder, renal, or chronic respiratory problems).

Treatment and study plan

Primary outcomes

'Best Estimate Diagnosis' of ADHD applied in the intended population in settings with the intended users

Time frame: At prensentation to clinic with attention or behavior problems

Sponsors and collaborators

Lead sponsor

Lexicor Medical Technology, LLC

Industry

Registry information

Official study title

Best Estimate Diagnosis Used to Evaluate EEG in Association With ADHD in a Multi-Site, Clinical Sample of Children and Adolescents

Acronym: NEBA

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2008
First posted: Jan 16, 2008
Registry last updated: Jul 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed