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 specific wavelengths, pulse rate and delivery method being used by Vielight Inc. in their not-yet-launched ‘Neuro-3 and Vielight810 product line of near-infrared (NIR) photobiomodulation technology on default mode network (DMN) behavior. DMN change will be assessed through repeated measurement of surface EEG amplitude and connectivity before and after approximately forty, 20-minute treatment sessions over two months. 
 
Default Mode Network (DMN)
The DMN defines a set of cortical and subcortical brain regions that have the most structural and functional relationships that are active when we are ‘at rest’, i.e., are not engaging with or responding to an external or internal stimuli or tasks. [1] Structurally, the DMN consists of the precuneus and adjacent posterior cingulate/retrosplenial cortex, the medial prefrontal cortex and inferior parietal lobes/angular gyrus as well as the medial temporal lobe. [2] 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.’[3] 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 opportunity to purchase a Neuro 3 unit after consenting to have a QEEG conducted prior to and after 2 months of active particiption. 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 will pay for the first QEEG assessment ($250) and QMF will pay for the second recording. All other assessments and consultations are provided at no additional cost.
 
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 recordings along with demographic and diagnostic and other testing results will be forwarded to the principal investigator for further analysis and aggregated results provided to the study sponsors.
 
Subject Selection and Compensation
Subjects can purchase the Vielight at a 10% discount and receive all individualized instruction, training and consultation services at no cost.
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 Vielight Neuro 3 with the understanding that they can elect to receive an 80% refund of the purchase price should they return the unit in good working order within 6 months of purchase. Subjects do not receive any additional compensation for their participation in this study. Subjects will be provided with a comparative report of their QEEG analysis results which is a $2000 value. 

NOTE: Participants in our open-label clinical trial can receive a 20% discount on the Vielight's retail purchase price. Clinical trial participants are required to obtain an 8-minute eyes open and eyes closed Quantitative EEG (QEEG) at our office located in the greater Philadelphia area. If our office locations are not convenient then Quietmind Foundation will assist in identifying qualified QEEG providers in your area for which there will be an additional cost involved. Clinical trial participants must obtain a QEEG ($150-$300) before starting use and after two months application of the photobiomodulation protocol.  Participants will get a 10% discount at time of enrollment and the other 10% is provided as a rebate when the second QEEG recordings are successfully received.
 
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  marvinberman@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.