Fred S. Starr, M.D., BCIA-EEG 1 Improvement of Symptoms Following Administration of Respen-A to a 14-Year-Old Boy with Autism Significant Changes Demonstrated Using State-Of-The-Art Brain Imaging Techniques Press F5 to start slide show. Click mouse or hit space bar to advance.

Fred S. Starr, M.D., BCIA-EEG 2 Quantitative Electroencephalogram (qEEG) The qEEG is a technique that allows a detailed two and three dimensional electrical picture of a subjects brain to be generated with the help of a sophisticated statistical computer program.

Fred S. Starr, M.D., BCIA-EEG 3 qEEG The enormous scientific body of clinical literature is, by itself, a testament to the high degree of reliability and validity of QEEG as well as evidence of the general acceptance of QEEG as a reliable, sensitive and clinically valuable measure. There is an extensive body of peer reviewed literature quantifying the superior reliability (i.e., reproducibility or the ability to repeat a measurement), validity and specificity of QEEG. To date, there have been over 1400 peer-reviewed scientific articles using qEEG as a clinical research tool. There are an estimated 16,000 qEEG practitioners in the US alone.

Fred S. Starr, M.D., BCIA-EEG 4 Professional Organizations acceptance of qEEG The American Medical EEG Association (AMEEGA) endorses QEEG as reliable The EEG and Clinical Neuroscience Society (ECNS) endorses QEEG as reliable The American Psychological Association endorses QEEG as reliable. The International Society for Neuronal Regulation (ISNR) endorses QEEG as reliable. The Association for Applied Psychophysiology and Biofeedback (AAPB) endorses the QEEG as reliable. The International Society for Brain Electromagnetic Tomography (ISBET) endorses QEEG as reliable.

Fred S. Starr, M.D., BCIA-EEG 5 qEEG Validity qEEG has been found to meet the Frye Standards of admissibility in several federal and state court cases. In Steif vs. Greyhound Lines, (United States District Court, Southern District of New York docket # 08 cv 2892 February 10th, 2009), based on professional testimony, The Hon. Judge Naomi Buckwald ruled, without a formal hearing, that the qEEG is a scientifically valid instrument on par with MRI, PET and CT scans.

Fred S. Starr, M.D., BCIA-EEG 6 qEEG and Autism The qEEG of Autistic Patients has a specific morphology. EEG studies of Autism typically show a U, shaped function of power vs. frequency. Elevated power is seen at low (delta/theta) and high frequencies (beta/ gamma). Reduced power is seen in alpha frequency bands. (Developmental Neuropsychology, Thatcher et al. June 25, 2009)

Fred S. Starr, M.D., BCIA-EEG 7 Reading the qEEG There are two different types of scans; a two-dimensional scan, and a three- dimensional scan (LORETA). The two dimensional scan is based on surface electrical patterns. The conventional digital EEG recording is computed as a Fast-Fourier Transform of power vs frequency. The FFT function is then compared to an FDA approved Z-Score database that uses a univariate Gaussian Distribution to compare the subject's electrical patterns to an age and gender matched group who have been evaluated and found to be free from psychiatric and neurological disorders. The maps show the pattern of the sensors that were placed on the head during the recording, with the top of the map representing the front of the head. Green indicates areas that match the database. These green areas are considered to be functioning normally. Areas of orange and yellow indicate an over abundance of a specific brainwave, or frequency. Areas of blue indicate low amounts of a specific brainwave.

Fred S. Starr, M.D., BCIA-EEG 8 Autistic Patient 1 The next slide shows the Fast-Fourier Transform (FFT) of Patient 1 before and after administration of Respen-A. The first slide clearly demonstrates the U, shaped power/frequency curve. The second slide shows a statistically significant change and normalizing of the U, curve.

Fred S. Starr, M.D., BCIA-EEG 9

10 Two Dimensional Map Pre-Post Respen-A Autistic Subject These cartoon, brainmaps are a representation of the previous slide. You are looking down at the top of the head, with the nose pointing up. Green means there is no significant deviation from the normal database. Red means that the brain activity over that region is too high, Blue means it is too low. Pre-Respen-A is on top, post Respen-A is on the bottom.

Fred S. Starr, M.D., BCIA-EEG 11 Pre-Post Respen-A Administration

Fred S. Starr, M.D., BCIA-EEG 12 Loreta Time Domain Analysis (Low Resolution Brain Electromagnetic Tomography) The following 2 slides use a powerful technique for 3-dimensional brain imaging called Loreta (The KEY Institute for Brain-Mind Research). Using the Loreta method, a difference of 8.5 standard deviations is found when comparing the pre and post Respen-A digital EEGs using a Paired t- Test, and Pearsons Correlation Coefficient. The possibility of this change due to change alone is greater then % 1. Pascual-Marqui RD, International Journal of Psychophysiology 1994, 18: Pascual-Marqui RD. Review of Methods for Solving the EEG Inverse Problem. International Journal of Bioelectromagnetism 1999, 1: Pascual-Marqui RD, Psychiatry Research-Neuroimaging 1999, 90: Frei E, Human Brain Mapping 2001, 14:

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Fred S. Starr, M.D., BCIA-EEG 15 Conclusion There is a specific EEG morphology associated with Autism. Respen-A administered to autistic patients with this characteristic EEG morphology leads to significant alterations in the EEG, resulting in major changes in the underlying neuronal activity and are far greater then can be explained by chance alone. The resultant shifts in brain activity that occur when Respen-A is administered to autistic patients approach a more normal functioning brain and are associated with an improvement in the core symptoms of autism.