NeuroLex EEG-Based ADHD Assessment Aid, Pivotal Study

Attention Deficit Disorder With Hyperactivity Clinical Trial

— NEBA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00595751
• Other study ID #: 004-1.6
• Status: Completed
• Phase: N/A
• First received: January 7, 2008
• Last updated: July 29, 2008
• Start date: December 2007
• Est. completion date: June 2008

Study information

• Verified date: July 2008
• Source: Lexicor Medical Technology, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Hyperkinesis

Locations

Country	Name	City	State
United States	Medical College of Georgia	Augusta	Georgia
United States	Rakesh Ranjan, MD & Associates	Beachwood	Ohio
United States	Harmonex	Dothan	Alabama
United States	Mercer University School of Medicine	Macon	Georgia
United States	LSU, HSC	New Orleans	Louisiana
United States	Eminence Research, LLC	Oklahoma City	Oklahoma
United States	Oklahoma University Child Study Center	Oklahoma City	Oklahoma
United States	SUNY Upstate Medical University	Syracuse	New York
United States	Children's Specialized Hospital	Toms River	New Jersey
United States	Indian Crest Pediatrics	Westminster	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Lexicor Medical Technology, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	'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	No