NeuroLex EEG-Based ADHD Assessment Aid, Pivotal Study

NCT00595751 | Completed

• 1 other identifier: 004-1.6
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 10

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Keywords

ADHD, Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• '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

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Lexicor Medical Technology, LLC: lead

Study Sites (10)

Harmonex

Dothan, Alabama, 36303, United States

Location

Indian Crest Pediatrics

Westminster, Colorado, 80021, United States

Location

Medical College of Georgia

Augusta, Georgia, 30912, United States

Location

Mercer University School of Medicine

Macon, Georgia, 31207-0001, United States

Location

LSU, HSC

New Orleans, Louisiana, 70118, United States

Location

Children's Specialized Hospital

Toms River, New Jersey, 08755, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

Rakesh Ranjan, MD & Associates

Beachwood, Ohio, 44122, United States

Location

Eminence Research, LLC

Oklahoma City, Oklahoma, 73139, United States

Location

Oklahoma University Child Study Center

Oklahoma City, Oklahoma, 73177, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Humberto Quintana, MD

  LSU, HSC

  STUDY DIRECTOR

• Steve Snyder, Ph.D.

  Lexicor Medical Technology, LLC

  STUDY CHAIR

• Humberto Quintana, MD

  LSU, HSC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 7, 2008
• First Posted: January 16, 2008
• Study Start: December 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 30, 2008

Record last verified: 2008-07

Locations

US (10)