NeuroLex EEG-Based ADHD Assessment Aid, Pivotal Study
- Conditions
- Attention Deficit Disorder With Hyperactivity
- Registration Number
- NCT00595751
- Lead Sponsor
- Lexicor Medical Technology, LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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.
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method '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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Medical College of Georgia
🇺🇸Augusta, Georgia, United States
LSU, HSC
🇺🇸New Orleans, Louisiana, United States
Children's Specialized Hospital
🇺🇸Toms River, New Jersey, United States
Harmonex
🇺🇸Dothan, Alabama, United States
Indian Crest Pediatrics
🇺🇸Westminster, Colorado, United States
Mercer University School of Medicine
🇺🇸Macon, Georgia, United States
SUNY Upstate Medical University
🇺🇸Syracuse, New York, United States
Rakesh Ranjan, MD & Associates
🇺🇸Beachwood, Ohio, United States
Eminence Research, LLC
🇺🇸Oklahoma City, Oklahoma, United States
Oklahoma University Child Study Center
🇺🇸Oklahoma City, Oklahoma, United States