Clinical trial NCT00595751: NeuroLex EEG-Based ADHD Assessment Aid, Pivotal Study
Official title: Best Estimate Diagnosis Used to Evaluate EEG in Association With ADHD in a Multi-Site, Clinical Sample of Children and Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: ADHD, Attention Deficit Hyperactivity Disorder
Lead sponsor: Lexicor Medical Technology, LLC
Sponsor class: INDUSTRY
First posted: 2008-01-16
Enrollment: 300
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study focuses on individuals who have consecutively presented to participating clinics with suspected attention and/or behavior concerns and would receive a clinician's comprehensive evaluation for ADHD. The study population includes male and female participants aged 6-17.99 years regardless of race, ethnicity, and socioeconomic origin. Because of inclusion of patients with consecutive presentation to provide a representative clinical sample, the exact numbers for sub-groups will not be controlled. The study population will include patients with comorbid conditions. The non-ADHD subgroup will include patients with other causes of attentional concerns, which may include other common psychiatric disorders, organic causes of attention problems (such as poor hearing, vision disturbances, remote head injury, substance abuse), and/or no diagnosis.

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.


Eligibility criteria: 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).

Primary outcomes:
measure: 'Best Estimate Diagnosis' of ADHD applied in the intended population in settings with the intended users
timeFrame: At prensentation to clinic with attention or behavior problems
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Harmonex
state: Alabama
city: Westminster
country: United States
facility: Indian Crest Pediatrics
state: Colorado
city: Augusta
country: United States
facility: Medical College of Georgia
state: Georgia
city: Macon
country: United States
facility: Mercer University School of Medicine
state: Georgia
city: New Orleans
country: United States
facility: LSU, HSC
state: Louisiana
city: Toms River
country: United States
facility: Children's Specialized Hospital
state: New Jersey
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Beachwood
country: United States
facility: Rakesh Ranjan, MD & Associates
state: Ohio
city: Oklahoma City
country: United States
facility: Eminence Research, LLC
state: Oklahoma
city: Oklahoma City
country: United States
facility: Oklahoma University Child Study Center
state: Oklahoma
Study officials:
affiliation: LSU, HSC
name: Humberto Quintana, MD
role: STUDY_DIRECTOR
affiliation: Lexicor Medical Technology, LLC
name: Steve Snyder, Ph.D.
role: STUDY_CHAIR
affiliation: LSU, HSC
name: Humberto Quintana, MD
role: PRINCIPAL_INVESTIGATOR
References: