NeuroLex EEG-Based ADHD Assessment Aid, Pivotal Study

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00595751

Acronym

NEBA

Enrollment

300

Registered

2008-01-16

Start date

2007-12-31

Completion date

2008-06-30

Last updated

2008-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

ADHD, Attention Deficit Hyperactivity Disorder

Brief summary

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

6 Years to 18 Years

Healthy volunteers

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).

Design outcomes

Primary

Measure	Time frame
'Best Estimate Diagnosis' of ADHD applied in the intended population in settings with the intended users	At prensentation to clinic with attention or behavior problems

Countries

United States

Outcome results