An Examination of Whether Infrared Light Therapy Can Reduce Stress in People With Epilepsy

WHO claims that epilepsy effects over 50 million people world‐wide. First line treatmentfor seizures has been medication for well over 50 years with mixed results. There aremany types of seizures, and the medications prescribed hope to target the type diagnosed,but while they may control the seizures to some effect, they also are riddled with sideeffects that create further duress. Other interventions may include surgery, vagal nervestimulation (VNS) and other neurostimulation methodologies, diet and other lifestylechanges, and behavioral modification1. Comorbidities of epilepsy include anxiety, stroke,depression, ADHD, and possibly physical health compromises due to falling2. Stress oftenprecipitates epileptic seizures, whether the syndrome is congenital, metabolic,electrophysiological, or environmental in nature3, 4.Turner5 highlights a need for better interventions for this population, and the currentproposal hopes to learn if photobiomodulation (PBM), a modern intervention which hasshown promise in many syndromes, including anxiety, Parkinson's disease, pain andinflammation6 can reduce perceived stress, which in turns informs a healthier lifestylefor people with epilepsy (PWE) and reduce the effects of this disease. Since thisintervention is quite new, few research projects have been published in this area.Light is a fascinating phenomenon. Most people can identify color, and this is because ofhow it vibrates7. It's the vibration that causes us to feel warmed (yellows) or cooled(blues) since the speed of the vibration is stimulating neuronal communication. It's abrilliant innovation to use this property in photobiomodulation (PBM), which is the useof near‐infra red light, as a clinical tool to enhance brain function on a cellular andchemical level. It is understood that what light therapy provides is a mitochondrialstimulatory mechanism that ultimately increases blood and cerebral spinal fluid (CSF)flow, cerebral oxygenation, and ATP production, as well as promote brain stabilizationand self‐regulation, and reduces inflammation8. It has been shown that the emitted lightdoes, in fact, penetrate the skull and reach the desired cortical levels of the brain tofacilitate the necessary mechanism to fulfill its goals9, 10.The positive effects on mitochondrial health with PBM, and this interaction withepileptic brain behaviors11, as well as with neurodegenerative diseases12, 13,Parkinson's14, inflammation15, and TBI16 among others has been shown. In this study, weare primarily looking at if PBM can facilitate reduction of perceived stress in the PWEpopulation. It is prudent to establish that we are not treating epilepsy because thedevice we're using is not FDA‐cleared for brain‐based procedures. However, currentliterature supports this, and present anecdotal evidence advises this intervention to bevery successful and validates the proposed rigorous investigation.The current study aims to use PBM to reduce stress in participants with epilepsy as acomplementary therapeutic modality for improving quality of life and reducing suffering.PWE will be recruited to 4 clinical sites within the U.S. (Cincinnati, Houston, Miami,Warren, OH) and provided with PBM 3x/weekly for forty‐five, 20‐minute sessions, which maylast between 15 and 20 weeks. They will have intake (T0), baseline (T1), mid (T2) post(T3) and 6‐month follow‐up (T4) assessment sessions in addition to the 45 PBM sessions.The assessments include routine EEG recordings, the following metabolic testing: heavymetals & minerals, Enviro Complete, thyroid, anemia and lipid panels, HbA1c, CBC,c‐reactive protein, vitamin D, homocysteine, OxLDL, F2‐Isoprostane/Creatinine Ratio,Glutathione, basic metabolic panel, DutchPLUS panel, and OAT oxidative stress; thefollowing behavioral inventories: The Perceived Stress Scale, Healthy Lifestylequestionnaire (HLPCQ), Holmes Rahe Life Stress Inventory, NDDI‐E depression scale, GAD‐7,Beck Anxiety Inventory, and the Adverse Childhood Events (ACE). We will ascertain sleepmetrics through the use of the Õura ring. Please find the schedule of these labs andassessments in Appendix IV Assessment Schedule. For more information about what eachassessment provides, please refer top Appendix IX. The EEG, metabolic testing andbehavioral inventories will serve to correlate objective and subjective findings.HYPOTHESES: ‐ PBM, when applied 3 times weekly over a 15‐20‐week period (45 sessions), will reducebehavioral symptoms of the stress accompanying epilepsy by at least 20% as shownbased upon psychological inventories (see Appendix I). ‐ PMB, when applied 3 times weekly over a 15‐20‐week period (45 sessions), willpositively affect brain connectivity metrics (bring z‐score values closer to themean based upon a neurotypical database comparison [Appendix II]), in alpha peakfrequency and in specific networks that correlate with h positive outcomes inbehavioral symptoms as outlined in Hypothesis 1. ‐ PBM, when applied 3 times weekly over a 15‐20‐week period (45 sessions), will tendto normalize lab values as measured by urine, blood, and hair samples throughout thestudy.Procedures:This is a single‐blinded, randomized clinical study design, that will strive for 80participants who have been medically‐diagnosed with epilepsy and will perform astatistical power analysis at 40 participants to determine the most efficient n toaccomplish meaningful outcomes. Kerson will provide informed consent and IRB approvalthrough the Saybrook University IRB. The four sites (Cincinnati, Stephanie Ryall;Houston, Ron Swatzyna; Miami, Natasha Nesic; Warren, OH, Holly Maggiano) will recruitparticipants from the sites listed in Appendix III (more sites are being considered) andrandomized using blinded randomization methodology to a 2:1 grouping (active, controlrespectively). The Vielight Pro 2 (Vielight Neurotechnology, Toronto, Canada) device willprovide the PBM active and control interventions.At the Intake Meeting (T0), once time is allowed for informed consent discussion and issigned, intake assessments will occur. The participant will go to an outside lab tocomplete preliminary lab samples. Once all inclusion criteria are met, the baseline (T1)measures will be taken, and another lab visit will take place. Mid‐session assessment andmore lab work will occur between PBM sessions 21 and 22 (T2). One week after completionof the intervention post‐assessments and lab work will be administered (T3). Sessionswill be numbered S1‐S45. Follow‐up assessments and lab work will occur at 6 monthspost‐intervention (T4).This study will utilize TherapyNotes at www.therapynotes.com (TherapyNotes, Horsham, PA,USA), a HIPAA‐compliant online software for participant reports and internalcommunications. As well, a script‐like protocol will be adhered to at each of the foursites to provide confidence that all sites are regulated in style and clinical atmosphereto maintain fidelity. The study fidelity monitor (Kerson) will periodically join sessionsvia Zoom to confirm and support uniformity at all sites with all researchers, techniciansand others who will be in contact with the participants.