Wireless EEG and Attention Evaluation System for ADHD

Period of Performance: 08/15/2006 - 07/31/2007

$450K

Phase 2 SBIR

Recipient Firm

Cleveland Medical Devices, Inc.
CLEVELAND, OH 44103
Principal Investigator

Abstract

DESCRIPTION (provided by applicant): The overall aim of this project is to develop a highly portable and quantitative Neurobehavioral Attention Evaluation Device (NeuroADTM) for the identification and quantitative evaluation of medication/therapy in children/adults with attention deficit hyperactivity disorder (ADHD), as well as children with ADHD-like symptoms related to sleep disordered breathing (SDB). ADHD and SDB are relatively common problems in children. The prevalence of snoring, ADHD, and SDB are 10%, 7%, and 2% respectively. Furthermore, recent studies have suggested that 15-25% of ADHD diagnoses may be secondary to unrecognized SDB. There is currently no independent diagnostic test for ADHD and the current method of diagnosis is somewhat subjective. NeuroAD provides an objective, practical, and quantitative means of assessing ADHD by combining a highly portable multi-channel wireless EEG acquisition and analysis device with an auditory-based test of attention and advanced signal processing algorithms. The 15 minute test protocol can be administered at virtually any location (primary care physician/pediatrician office/clinic, psychiatrists' office/clinic, etc.). Phase I effort involved the successful implementation of the Multi-EEG NeuroADTM in a number of clinical studies with both normal and ADHD, children and adults. NeuroADTM s novel algorithms and discriminating indices, which combine EEG-related variables with the profile of the behavioral response, have been shown to be very effective in distinguishing normal children from children with ADHD and ADHD-like symptoms. Phase II effort centers around finalizing and fine-tuning the hardware/software/algorithms developed in Phase I. In addition, we will develop NeuroADTM which will be a miniaturized configuration using NeuroADTM s coin-sized EEG device. This highly portable and easy-to-use device will utilize a commercial hand-held PDA along with an easy-to-attach headband for fast and convenient placement of the electrodes. This system will undergo extensive multi-center clinical evaluations with adult and children subjects (normal, ADHD pre- and post-medication, and SDB pre- and post-adenotonsillectomy). The results of these tests will be grouped together to perform a comprehensive statistical analysis to demonstrate the effectiveness of NeuroADTM in screening and identifying of ADHD and evaluating the effects of medication/therapy. The Neurobehavioral Attention Evaluation Device (NeuroADTM) that is being developed under this project is aimed to be utilized as an ambulatory, easy-to-use, and highly quantitative method to screen for the presence of ADHD and evaluating the effects of medication/therapy. The 15-minute test can be administered at virtually any location (primary care physician/pediatrician office/clinic, psychiatrists' office/clinic, etc.) and has the potential to differentiate ADHD from ADHD-like symptoms caused by sleep apnea and other sleep disordered breathing.