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Principal Investigator: Marvin H Berman Ph.D.
Photobiomodulation is becoming a clinically valuable bench-to-bedside tool in current neuroscience research as more and more applications are found for this form of noninvasive, nonpharmacological intervention. Our focus in this program is to evaluate the impact of a specific wavelength, pulse rate and delivery method of intranasal near-infrared photobiomodulation (IPBM) technology on long COVID affected cognitive, functional behavior. Outcome measures will include quantitative EEG (QEEG) and Event Related Potentials (ERP) Brain electrical network change will be assessed through repeated measurement of surface EEG amplitude and connectivity before and after approximately forty, sixty 15-minute treatment sessions over two months. The robustness of the average pattern in the resting state EEG exists along with ‘marked variation in individual connectivity strengths for any given pair of brain regions.’ This offers away to measure the broadest functional impact of neuromodulating interventions, e.g., near-infrared phototherapy and LORETA z-score neurofeedback, within and across normative and clinical subpopulations Methodology Subjects will be provided with the IPBM unit after informed consent is obtained to have a QEEG conducted prior to and after 2 months of active participation. You authorize the providers to share the QEEG data files being recorded with the principal investigator. Subjects will have their EEG recorded using current recording methods prior to beginning treatment sessions which will be conducted every other day and no more than daily for two months at which time another EEG recording will be made and comparisons made between pre-and post-treatment conditions. Subjects may be asked to pay for the QEEG assessments and IPBM device if they decide to keep the unit on completion of all the trial period and required testing protocol. Additional assessment procedures may be included, based on the subject/provider professional relationship and described in the informed consent documentation. Deidentified (subject number and code) raw QEEG/ERP recordings along with demographic and diagnostic and other testing results will be forwarded to the principal investigator for further analysis and publication. Subject Selection and Compensation Appropriate subjects for this trial are adults over the age of 18 who have given written consent to participate in a clinical trial and have purchased the investigational device with the understanding that they may receive an 100% refund of the purchase price should they return the unit in good working order after the 2 month study period. Subjects will receive no additional compensation for their participation in this study. Subjects will be provided with a comparative report of their QEEG analysis results which is equivalent to $2000 in professional services. The research is critically important to marketing as I'm sure you know so this strategy is essentially bootstrapping the collection of reliable electrophysiological data regarding basic level connectivity measures and clinical/performance data outcomes. I think it will add improved outcomes and greater engagement leverage to therapeutic, consultation and coaching relationships by providing a safe, easily deployed, direct and efficient neurobiological intervention along with your current neuromodulation and coaching techniques. Additional information: Marvin H. Berman PhD INFO@quietmindfdn.org Reference: [1] Greicius,M.D.,Supekar,K.,Menon,V.,Dougherty,R.F.,2009. Resting-state functional connectivity reflects structural connectivity in the default modenetwork.Cereb.Cortex 19,72–78. [2] Horn, A., Ostwald,D., Resiert, M., Blankenburg, F. The structural–functional connectome and the default mode network of the human brain. NeuroImage Volume 102, Part 1, 15 November 2014, Pages 142–151. [3] Hahn, A et.al. Individual Diversity of Functional Brain Network Economy. Brain Connectivity, Vol 5, #3, 2015. |