In this phase I project, Koronis Biomedical Technologies (KBT) proposes to develop an electroencephalography (EEG) based neurofeedback video game to enable individuals to improve neurocognitive processes associated with Attention Deficit Hyperactivity Disorder (ADHD). Neurofeedback is a form of biofeedback in which real-time measures of brainwave activity are presented to the individual in a manner that enables them to willfully control aspects of their brainwave activity with the goal o actively selecting desirable states or reducing time in undesirable states. A major goal of this project is to demonstrate, through scientific basis, under what training conditions do users get better at generalized cognitive training. This is an important and timely research objective given a number of high profile failures to find gains in general cognitive abilities, "transference," as function of training. The phase I research program will design and construct an EEG Neurofeedback system that incorporates this feedback into a demonstration video game for children with ADHD and to conduct a pilot human study to evaluate and to test usability of the system. Positive evidence of trainability of executive function will form the basis of a properly controlled full human study in Phase II.

Public Health Relevance

Overall clinical significance for the proposed system is driven by the large number of ADHD diagnoses being made each year (according to the CDC, 5.4 million children ages 4-17 have been diagnosed with ADHD as of 2007), the long term proven ineffectiveness of drug treatment and the very poor rate of medication compliance caused by side effects, emotional blunting that adolescent/teens complain, and reluctance of parents to give the meds (Adderal is an amphetamine and methylphenidate is a cocaine analogue). Pharmacologic interventions, while reducing some of the symptoms of ADHD in the first year or two of use, fail to show ANY effects in the long term. Evidence demonstrating this was produced by the MTA and PATS studies. Further, even when medications are effective, there is little effect beyond the half-life of the medicine (typically measured in hours). Thus, ALL teenagers with ADHD are in fact completely untreated in the evening hours. This means the full range of their ADHD symptoms are present during the critical hours for homework and during the weekend hours when they are likely to be out and about with their friends. Reckless sexual, substance and other behaviors can be expected as a result of this failure to treat symptoms by producing actual long term changes in the brain. NF has been shown to produce changes not only in brain electrophysiology but in cortical white and gray matter. Dr. Tallal's work with Scientific Learning (www.scilearn.com) has shown real-world generalization, particularly for the early studies where she changed the ability of children to hear the initial formats of consonants and ended up improving speaking, reading, and socialization. Likewise, a review of the published NF ADHD studies have also shown improved grades, IQ performance and improved parent and teacher ratings, which demonstrate real-world generalization.

Agency
National Institute of Health (NIH)
Institute
National Institute of Mental Health (NIMH)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43MH106472-01
Application #
8715059
Study Section
Special Emphasis Panel (ZRG1-RPHB-R (13))
Program Officer
Grabb, Margaret C
Project Start
2014-08-01
Project End
2015-07-31
Budget Start
2014-08-01
Budget End
2015-07-31
Support Year
1
Fiscal Year
2014
Total Cost
$223,240
Indirect Cost
Name
Koronis Biomedical Technologies Corporat
Department
Type
DUNS #
140696332
City
Maple Grove
State
MN
Country
United States
Zip Code
55369