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Co-Investigators:
Marvin H Berman Ph.D. Quietmind Foundation Jeffrey Leighton, Ph.D., Center for Neurospiritual Studies Photobiomodulation also called low-level light therapy 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 treatment approach. This study seeks to evaluate the impact of repeated intranasal delivery of 1070nm near-infrared photobiomodulation (IPBM) technology on long COVID brain fog and loss of smell. Given no outside funding is available for this trial, subjects are required to pay a $290 equipment fee that covers the cost of exclusive use of the device including shipping. Study-related testing and consultation services (CNS Vitals, QEEG comparative data analysis*, and online telehealth consultations) are provided at no additional cost. * Comparative analysis of Pre/post QEEG will be provided at no cost, however, QEEG acquisition fees, conducted by local providers are at the participants' expense and generally cost $250 for the 8 minute Eyes Open and Eyes Closed recording of EEG data. Outcome measures will include online neuropsychological assessment (CNS Vitals) and qualitative odor detection sensitivity. Treatment protocol consist of either twice daily, 15-minute or once daily 30 minute stimulation sessions for two months or (60 days). Subjects are also being offered the opportunity, at their own expense, a comparative analysis of the INPBM's effect on their brain's electrical connectivity. 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 analysis, along with the CNS Vitals information will provide a way to measure the functional impact of the INPBM's neuromodulating intervention and inform potential therapeutic options for continued clinical improvement. Study Methodology After enrollment, including informed consent completion, prior treatment data collection and CNS Vitals pre-testing, subjects will receive , the intranasal photobiomodulation device (INPBM) unit, for their exclusive use, during the study period. Subjects may,at their own expense, opt to obtain and share with the researchers, baseline and post treatment QEEG assessments, . You authorize the providers to share the QEEG data files being recorded with the principal investigator. Subjects wanting no-cost evaluation of their QEEG recordings by the researchers are required to follow specific recording parameters outlined in the informed consent documentation. Subjects will use the INPBM once daily (30min) for two months. CNS vitals and independent medical evaluations will be obtained upon study completion. Deidentified (subject number and code) raw QEEG/ERP recordings along with demographic and diagnostic (CNS Vitals) and other testing results will be forwarded to the principal investigator for further analysis and publication. Subject Selection and Compensation Eligible subjects for this trial must be age18- 75 who have given written consent to participate in a clinical trial and agree to paying a $275 (+s/h) equipment fee for exclusive use of the investigational device. Subjects can return the device at any time prior to or at the end of the 2-month study period and receive an 100% refund if the equipment fee if the device is determined by the investigators to be in good working order and in the original packaging. Subjects will receive no additional compensation for their participation. Subjects may, on written request, be provided with a comparative report of their CNS Vitals and/or QEEG analysis results at no additional cost. We believe this research is critically important in our efforts to develop effective low-cost, safe and reliable therapies to address the urgent need for ways to combat COVID 19 related neurological injury. This strategy is QMF's attempt to 'bootstrap' the collection of reliable neuropsychological and electrophysiological data to evaluate such treatments' clinical outcomes. These and future studies will inevitably improve treatment outcomes and provide the requisite information needed to design safe, effective, easily deployed, low-cost, and rapidly scalable interventions. For additional information or to enroll write to: 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. |
| handheld_intranasal_photobiomodulation_applicator_instructions.pdf |
| 1qmf_intranasal_pbm_informed_consent_2024.pdf |
