Monday, October 21, 2024

Photobiomodulation and Skin Cancer: Summary of Current Evidence

INTRODUCTION- The Integrative Health Research Center/IHRC in NYC conducted a 2-year performance study in the use of various LED-based near-infrared light health devices.  The test was aptly named "Scan & Treat" whereby each model was tested on consenting subjects (as directed by its accompanying instructions and training programs). Brands ranged in frequency and design supporting various health claims.  All devices under review presented documentation and instructions based on each manufacturer's standard testing policies as approved by regulatory agencies for public market.

As part of any device research protocol, standard interest for user safety led to this micro-inquiry/survey of these devices, exploring the probability of injury and risk.  This, our evaluators seek any form of published evidence about the risks in applying radiative energy frequency and laser directly exposed to the skin within any close proximity.  Though designed for supposed therapeutic results, our challengers wish to explore any research concluding probable cause for concern or any form of negative effect.

Additional concern is PBMT's effects on cancers, especially skin cancers and melanoma where direct exposure of this 'light therapy' on an infected area may awaken or aggravate the cancer's  malignancy. Where PBMT is identified on the market (and with the brand's marketing claims) to reduce inflammation, an adverse concern is for the potential unknowns of a tumor's aggressiveness to be provoked by the device's exposure.

The following are statements and findings from a 2nd and 3rd level academic data search.  All references and expanded details are accessible by the links enclosed.


SAFETY INQUIRY/REVIEW (10-19-2024)
An academic research/report by:
Dr. Roberta Kline - editor, HealthTech Reporter / Women's Health Digest

Photobiomodulation therapy (PBMT) is the currently accepted term for the use of near (visible) or near infrared light to stimulate physiological processes in biological tissues. It is also often called low-level laser therapy (LLLT), which was introduced in the 1960’s. [De Pauli Paglioni, et al]

LED (Light Emitting Diode) is often included in PBMT and while around since the late 1920’s it is only since the late 1960’s that it has been used therapeutically. Its use is increasing in therapeutic applications as it is less expensive than laser. [De Pauli Paglioni, et al]

They both operate within defined spectrums of light, with visible red being 600-700 nm and near-infrared (NIR) being 700-1400nm. These wavelengths correspond to the maximal absorption of skin without creating heat.  [Torres, Angeli E et al.]

While there are differences between LLLT and LED, they have been found to be equally effective in many use cases, including wound healing, inflammation, and pain relief. [Torres, Angeli E et al.]

A screenshot of a computerDescription automatically generated

Table 1 source: Torres, Angeli E et al.


MECHANISM OF ACTION
PBMT works via absorption by mitochondrial chromophores including Cytochrome c oxidase and flavoenzymes, which facilitate electron transport and ATP synthesis. It also is involved in release of nitric oxide (NO) which is involved in mitochondrial antioxidant defense and would account for clinical and research observations that PBMT helps to mitigate oxidative damage from radiation or chemotherapy. Gene expression influenced to enhance regeneration and repair, including cell proliferation & migration, immune and angiogenesis. [Glass GE.]

Cells with higher concentrations of mitochondria appear to require lower doses for therapeutic effects, whereas cells such as fibroblasts and keratinocytes require more due to lower mitochondrial density. [Glass GE]


PBMT AND CANCER
Multiple cell culture and animal studies have shown that PBMT has little or no effect on cancer cell viability, nor does it induce neoplastic changes in normal cells. The rare studies that showed a possible effect were in animals with compromised immune systems. [Glass GE]

A large review published by Bensadoun RJ et al in 2020 showed that animal studies and clinical trials support the safety of PBMT related to tumor growth, and may even be beneficial for overall survival in patients with cancer. The conflicting results from a few in vitro cell culture studies were felt to be related to doses outside of normal clinical use, and thus not relevant to safety in humans.

In 2022, a position paper from the WALT Congress [Robijns J et al.] stated that PBMT has been shown to have a biphasic dose-response, with lower doses having potentially less effect and higher doses having potentially no beneficial or even adverse effects, that warrants further clinical research to clarity optimal dosage.

They also stated that the genetic variability of individual tumors, as revealed by the technology of precision oncology, may contribute to variable response to PBMT. Indeed, some tumors have genetic variations in genes that are targeted by PBMT, such as PI3K. One example is squamous cell cancers of the mouth, where up to 35% of tumors have alterations in the PI3K pathway. Thus, further research with this more individualized approach is needed and should replace one-size-fits-all approaches.

Their conclusion was that, although PBMT is generally safe for patients with cancer, there is a lack of definitive evidence regarding potential enhancement of tumor growth and long-term survival, thus more clinical trials and robust data regarding use with cancer are needed. They also specifically did not recommend direct treatments to the tumor, and advised that all patients should be fully informed of the potential benefits and risks.

 

References:

1) Glass GE. Photobiomodulation: A Systematic Review of the Oncologic Safety of Low-Level Light Therapy for Aesthetic Skin Rejuvenation. Aesthet Surg J. 2023 Apr 10;43(5):NP357-NP371. doi: 10.1093/asj/sjad018.

2) De Pauli Paglioni, Mariana, et al. "Tumor Safety and Side Effects of Photobiomodulation Therapy Used for Prevention and Management of Cancer Treatment Toxicities. A Systematic Review." Oral Oncology, vol. 93, 2019, pp. 21-28, https://doi.org/10.1016/j.oraloncology.2019.04.004.

3) Torres, Angeli E., and Henry W. Lim. "Photobiomodulation for the Management of Hair Loss." Photodermatology, Photoimmunology & Photomedicine, vol. 37, no. 2, 2021, pp. 91-98, https://doi.org/10.1111/phpp.12649.

4) Bensadoun RJ, Epstein JB, Nair RG, et al. World Association for Laser Therapy (WALT). Safety and efficacy of photobiomodulation therapy in oncology: A systematic review. Cancer Med. 2020 Nov;9(22):8279-8300. doi: 10.1002/cam4.3582.

5) Robijns, Jolien, et al. "Photobiomodulation Therapy in Management of Cancer Therapy-induced Side Effects: WALT Position Paper 2022." Frontiers in Oncology, vol. 12, 2022, p. 927685, https://doi.org/10.3389/fonc.2022.927685

Wednesday, October 9, 2024

Dr. Yvette Groszmann, OB/GYN - What is Sonology? (Ultrasound Imaging)

HealthTech Reporter is proud to present our next expert in the field of imaging. YVETTE S. GROSZMANN, MD, MPH, completed a residency in Obstetrics and Gynecology at Pennsylvania Hospital, Philadelphia. In 2009, she left general ob-gyn practice to pursue a fellowship in ob-gyn diagnostic ultrasound with Dr Benacerraf and is now an expert sonologist in early pregnancy and gynecologic ultrasound. She is a fellow of the American College of Obstetrics and Gynecology, a Fellow of the American Institute of Ultrasound (AIUM), former vice president of the American Institute of Ultrasound (AIUM), Chair of the AIUM Gynecology Community of Practice, and a lecturer at Harvard Medical School. She teaches gynecologic ultrasound to the Brigham and Women’s ob-gyn residents and REI fellows, has co-authored a textbook on gynecologic ultrasound, and lectures nationally and internationally.

 

In a recent interview, Dr. Groszmann shares her vision for improved patient care through the philosophy of direct contact with the patient and ultrasound probe. The concept of investigating and recognizing pathology is more efficiently captured by the physician and she discusses this in an excerpt from HTR newscast.


INTERVIEW TRANSCRIPT from Podcast (AIUM Speaker Series)- 5/2024
I became a Gynecologic Sonologist because two of the other physicians in my group were maternal fetal medicine doctors who also did gynecologic ultrasound, but they were more interested in the fetuses.  I frankly, was more interested in the pelvis. I transitioned over the years and I became a specialist in GYN ultrasound. I co-wrote a textbook on this topic. Maybe half of our practice is second opinions, especially in GYN ultrasound. Ultrasound is not typically performed by the physician. It's performed by sonographers (ultrasound technicians). They're taught very well but there is an added layer of validity when you, the physician is the one taking the images, when you understand the physiology and what you're looking at-- it affects interpretation. Our sonographers are excellent-   there's so much more control in scanning the patient if YOU the physician are the one navigating the probe firsthand.

 




Cohort Study (Part 1)- Dense Breast Scanning Survey / Molloy University: 
ACADEMIC PREFLIGHT STUDY OF ULTRASOUND SCREENING APPLICATIONS FOR DENSE BREAST CASES

Transcript by: Noelle Cutter, Ph.D.
Edited by: Roberta Kline, MD and Lennard M. Goetze, Ed.D

We started working with the Terason 3200t Ultrasound (hereinafter shall be referred to as the Terason) in the summer of 2022. The goal of the project was to be able to scan a limited number of younger premenopausal women under the age of 40 who are more likely to have dense breasts based on their status as being endurance based athletes. We have been exclusively using the Terason based on the recommendation of our lead radiologist Dr. Robert Bard.  The Terason became our lab scanner of choice to conduct the screening of 10 individuals in the lab on a voluntary basis to get a readout for their breast density. Endurance athletes are more prone to dense breast tissue, especially athletes under the age of 40. Mammographic density is the strongest risk factor for non-familial breast cancer among women, especially those under the age of 40.   Metastasis, tumor relapse, and resistance to therapy remain the principal causes of death for breast cancer patients and the lack of effective therapies calls for an improved understanding of the molecular mechanisms driving breast cancer progression. Early identification of mammographic density is an essential step in preventative health.


REMOTE COLLABORATIVE TEAM
The Dense Breast paradigm continues to plague our population of the underdiagnosed and underserved women. uniting with public advocates and legislative change makers like the ARE YOU DENSE? FOUNDATION raises significant public awareness in both the clinical and patient communities (see news feature).  Meanwhile, this cohort study received great support from the medical research and diagnostic society whereby scientific leaders like Dr. Robert L. Bard (diagnostic imaging specialist) and Dr. Roberta Kline (epigenetics expert in women's health) helped to spearhead their own respective areas of study to help offer new insight and data in support of the launch of this field research program.  

PORTABLE, HOSPITAL GRADE AND FIELD FRIENDLY
My technicians and I found the Terason to be "super portable" and upon scanning our first few subjects, we immediately understood why Dr. Bard suggested this brand and model. The picture quality and imaging system is very clear and the user interface is very easy to read. For someone who is not experienced or well trained in using an ultrasound, with one or two training sessions I was able to easily use the machine to work with our volunteer subjects. 


An underlying test is the feasibility of using the Terason itself in actual field work. The portability is astounding (to me). This means we can pack it up. I don't even need any sort of a car. I could throw it on my back and get on a bicycle and bring it to a, uh, a destination.  

Click image to see full scan report
As far as its' performance, my group and I did our own homework about its accuracy and reliability and what we often found was the common statement about it being "battle-tested"- in the EMS world). Targeting the triathlete community, all these features are critical advantages to roadside screening! It's easy to use and even easier to train other research assistants in the lab to use it. And with Dr. Bard (and his expert interpretation) on the receiving end of our scans, that is the ultimate peace of mind and a COMPLETE tele-health scanning paradigm. 


FINAL STATEMENT
Breast density is a key factor in early detection because mammograms routinely miss breast cancer in dense breasts, especially in younger and more athletic women. Ultrasound offers a supplemental scan and peace of mind because it finds the pathology and almost instantaneously distinguishes from a benign cyst from a possible cancer - or a definite cancer. Ultrasound even goes further because if there is a definite cancer or something highly suspicious of a cancer, you can look at the other organs such as the glands under the arm to see if it's spread into the lining of the lungs to see if it's invading the pleura or the lymph nodes in the abdomen or the brain. Since we are now armed with expert diagnostic over-readers and remote collaborative imaging options, I urge our gynecologic and obstetric community to take advantage of this affordable non-invasive screening solution. 



DR. NOELLE CUTTER is a professor of biology, ironman finisher, and advocate for dense breast screening.  United with an expanding research team dedicated to collecting data on women with dense breasts and screening options for these patients, her initiative aims to investigate and gather conclusive information about dense breasts in specific groups- including age, body mass index, and amount of physical activity and the underlying diagnostics of breast cancer tumors. This research program is under a partnership with Molloy College and Dr. Robert Bard, expert diagnostic cancer imaging specialist in NYC and other colleagues from the NY Cancer Resource Alliance. 
 




Epigenetic Research Notes: Profiling the Dense Breast Paradigm
A Clinical Report by: Dr. Roberta Kline


LINKING DENSE BREAST WITH BREAST CANCER
We have known for a very long time that there is an increased risk of breast cancer for women who have dense breasts. Until recently, the research has been lagging in terms of what's the molecular mechanism, why do dense breasts present an increased risk of breast cancer? Without this knowledge, we can’t address the root causes, and are left with a lot of trial and error based on incomplete understanding. 

It's very encouraging to know that currently there are 124 clinical trials ongoing looking at dense breasts and the relationship with breast cancer, anywhere from improved diagnostics, to treatment, to prevention, and, what’s close to my heart, to understanding the molecular mechanisms - what's happening at the cell level, at the genetic level that is causing different women to have an elevated risk of breast cancer.  One of the striking features that we're learning about dense breasts and what is creating that density is the microenvironment, which means the environment in the supporting tissue surrounding the glands. This includes fibroblasts and collagen. It seems that rather than estrogen being the dominant factor, it is inflammation that is creating the increased density of breast tissue. 



 





WHAT'S NEXT AFTER CANCER?

The Importance of Maintaining a Healthy Lifestyle and Monitoring

Written by: Dr. Leslie Valle-Montoya 

Cancer recurrence can occur months or even years after initial treatment, and it’s important to be aware that cancer can return in different tissues, not just where it was originally diagnosed. While this is a challenging possibility, there are proactive steps you can take to reduce the risk and protect your health.

Staying vigilant with regular check-ups, lifestyle adjustments, and continued screenings is essential. Early detection of any signs of recurrence greatly increases the chances of successful treatment. Maintaining a healthy lifestyle after being declared “cancer-free” is not always easy, but it’s vital. We are constantly exposed to environmental toxins in our food, water, and surroundings, so addressing the root causes of disease and making healthier choices is crucial. A nutritious diet, physical activity, and stress management all support overall wellness and strengthen the immune system. I often guide patients in addressing lingering dental infections and maintaining a healthy internal environment, whether by enhancing the microbiome or reducing bodily acidity, which cancer thrives on.

Avoiding smoking, limiting alcohol, and maintaining a healthy weight are also key to lowering the risk of recurrence. By focusing on what you can control—your health and regular monitoring—you empower yourself to stay well and ensure long-term health.





May 21, 2024, leading members of the NY Cancer Resource Alliance (NYCRA) held a special meeting with State Senator Patricia Canzoneri‐Fitzpa...



27 Year Old Stage 3 Breast Cancer Victim Survived - Despite of Docs Who MISDIAGNOSED!   The Women's Health Collaborative and EARLIER DETECTION advocate Alexandra Fiederlein interviewed breast cancer survivor Jamie Butera a...



 

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Wednesday, October 2, 2024

Tech Review: Wearable EEG/Cognitive Pacing Headband- Feat: NEUROVINE



PART 2: CUSTOM TEST- EEG MONITORING THE MUSICIAN’S BRAIN AT PLAY
"An EEG can find changes in brain activity that might be useful in diagnosing brain disorders, especially epilepsy or another seizure disorder. An EEG might also be helpful for diagnosing or treating: Brain tumors. Brain damage from head injury.  It records electrical patterns in your brain. The test is used to help diagnose conditions such as seizures, epilepsy, head injuries, dizziness, headaches, brain tumors and sleeping problems. It can also be used to confirm brain death." 


DAY 7:  THROUGHPUT  PROCESSING 
Identifying the capacity of cognitive pacing is one major focus of  the  Neurovine  headband  and  App.  But  part  of  my  goal  in conducting tech reviews is to challenge the limits of this device. This  includes  collecting  data  about  one's  brain  waves.    As indicated in the definition of an EEG *above), the sensitivity of this device is meant to access such vital and critical biometrics is meant to recognize the varying patterns of the brain.  A great exercise  for  this  is  testing  one's  capacity  while listening/studying  a  musical  piece  or  playing  a  musical instrument. 


From  prior  clinical  studies,  it  is  observed  that  the  mind  of  a musician  travels  on  various  pathways:  there's  the  linear function during performance through the frontal and temporal lobe‐  that  which  recognizes  sound  overall.  There's the instructional / mathematical  analysis  of  the mind's ability  identify compositions.  There's  the  memory  aspect  of  music performance responsible for muscle memory (of the hands playing the instrument) aligned with reading music or matching the music it creates with a recognized piece of music. And then there's the mind's 'responsibility' to fulfill a composition or  to  duplicate a  recognizable  piece  of music  from  start  to  finish.  This  function may also  support  both  the  hand‐eye coordination and the thinking one step ahead when performing each note or phrase, then simultaneously going to the next line.  All this makes up playing a musical instrument, and all are aimed to be captured by the Neurovine. 

MUSIC CHOICES: GENRES OF VARYING COMPLEXITY
Every genre has its characteristics‐ and all are identified by the audience and their reactions to these musical works.  As a performer, I find the COMPLEXITY of the song has a lot to do with the ANXIETY LEVEL cast on the performer.  It is this ANXIETY that I theorize to cause BRAIN FATIGUE (what the Neurovine App was meant to scan for). 

To choose a combination of styles from Flamenco, Ragtime, Rock, Folk and Soft Jazz should output unique differences in the EEG graphs.   I put my theory to use by logging each length of musical piece with the full duration/timeline of the NV brain activity readings.   Thanks to my trainer, I was explained that the EEG device reads brain fatigue/energy and outside effects on the brain as well as processing activity.  So it is here that I captured a time‐based set of graphic scans within the timeline when I played each song‐ matching it with the EEG linear graph. My brain waves were clearly communicating each music piece/type, reflecting my mental involvement of the song with my guitar playing.  The higher brain wave levels indicate the STRESS I was putting my brain through by working on more complex solos and riffs.  I also understand that LISTENING also shows up  as  recordable  brain  fatigue metrics  ‐  which means  those  high  peaks  at  the  EEG  are most  likely  due  to  the mind's engagement and empathy for the more complicated areas of each musical piece. 

Reference:  p1) How Musical Training Shapes the Adult Brain: Predispositions and Neuroplasticity 

https://www.frontiersin.org/articles/10.3389/fnins.2021.630829/full




INTRODUCTION:  9/1/2022- IPHA NEWS kicks off a direct demo and test drive of the device called NEUROVINE®- a brain performance tracking headband and APP.  This portable headband using EEG (electroencephalogram) technology is designed to measure brain waves with the objective of offering cognitive pacing for those who have suffered any form of head trauma/concussion.  After an exclusive interview with co-founders CEO Ashleigh Kennedy, Ph.D., and CMO Matthew Kennedy, MD, MSc (from Ottawa, Ontario, CA), our editors identified their objectives in support of concussion monitoring by measuring brain health as part of optimizing their recovery process. Neurovine is marketed to offer "interactive monitoring program for athletes, students, professionals and anyone undergoing mentally strenuous work by alerting them to take brain breaks before an activity becomes too strenuous”.  (See July 19 interview)

TEST DRIVE OBJECTIVES:
In pursuit of a user review, our first goal is to check the device for its quality, user friendliness and perceived/actual values to its intended market.  By this, a fair test drive would mean exploring ALL of its features within a fair timeline, as well as all resources around the device (including tech support and instructional materials). 



PROLOGUE: Getting Ready to Studying Brain Waves
BRAIN WAVES are oscillating electrical voltages in the brain measuring just a few millionths of a volt. For this device review, our testers recognize the visual advantage of tracking and monitoring of brain waves using the Neurovine EEG reports after each activity based on the 5 types of wave patterns. 

Five major brain waves include:
• GAMMA (Concentration)
• BETA (Anxiety Dominant)
• ALPHA (Relaxed/Passive Attention)
• THETA (Deeply relaxed)
• DELTA (Sleep)

Given the option of a variety of activities (from the APP), the following 5 images are actual post-activity reports of some of brain exertion.  The uniqueness of each graphic appears to record the major brain wave patterns- reflecting on the brain's real-time reaction to that specific activity. For this review of a COGNITIVE PACING (for head injuries/concussion), one can see the potential benefit of such a personal device during all stages of one's day by helping to identify one's brain health. Extrapolating from the graphic scan, high exertion would indicate elevated strain and struggle for the brain. The PACING element of this wearable device will translate this high exertion by suggesting "it's time to slow down or rest".


The Proper Start:
Getting the Most out of the Neruovine Device 

9/3 - When testing any device like the Neurovine®, our HTR device testers offer our first helpful lesson- about the value of a proper instructional phase.  Getting to know any device should be based on more than its marketing videos or quick-start demos. Nothing replaces a comprehensive training or reading the full instruction manual thoroughly.  Getting proper step-by-step guidance could be the difference between experiencing the right benefits of the device an incomplete and unfair review.  Our testers have studied user/consumer behavior from this phase, and found the vast majority of first-time users tend to want the quick study guide version with just a basic understanding of how to start and use the product.  

By and large, today's products have indeed evolved to offer more simplified and more friendly APPs and UI (user interface) designs for the average user. But when it comes to health or medical technology, it truly pays to have direct access to a trainer (if available) or a more comprehensive FAQ document.  This is where important concerns like SAFETY, PROPER and IMPROPER USE, MAINTENANCE and ADDITIONAL BENEFITS can help provide a more intelligent test drive. If you can't get the company to dedicate you a personal trainer or orientation guide, or if the online/paper manual is simply too cumbersome to digest, a possible useful source for helpful instructionals may be from the world's favorite educational media: YouTube! 

REVIEW 1: The Neurovine Orientation Team: 
We commend the company for sending us some of the kindest and most patient professionals as instructors of  the Neurovine device. Understandably, a post-concussion monitoring device requires through guidance, but if this product is marketed to practitioners or the consumer, hiring trainers with deep insight on the many types of brain issues and their impressive understanding of the human condition.  I have ‘challenged’ my own trainer and the developers  with deep interest and found everyone helping us expressed true and deep care, incomparable patience and a level of professional  responsive attention  to  the introduction of  the  technology.  As a personal health‐related device, people‐contact is everything! 

THE SETUP: Preparing for Use
After finally receiving the Neurovine kit (complete with the power cord and saline dispenser), I could not wait to charge the device for the 24‐hour recommended charge time so I could pair it to my cell phone and get started right away.  I was somewhat impressed at the quality of what appears to be a fairly sports‐rugged feel. The hardware paired fairly quickly with my Droid phone with a few minor work‐arounds.  The app was quite friendly, stylish and soothing to the eyes (easy to read)‐ and this is important for anyone who may have a possible brain‐related injury that calls for this product. 


SALINE SOLUTION  FOR  THE  ELECTRODE CONTACTS
I  provided  an  alternate  solution  to  the factory's  sponge  dropper  (which  is  hardly controllable  and  tends  to  spill  and  drip everywhere).    Instead,  I  employ  my  Saline Nasal Mist Spray or a hand atomizer  (from a Dollar  store),  which  dispenses  a  much  more controlled mist and even amount of moisture to the contact points without any mess.  The App will not let you continue unless all 6 contact points are moistened, and my nasal spray satisfies the App every time! 

BRAIN GAMES:  Once paired, the app takes on a life of its own.  It speaks to the headband to set me up, starting with BRAIN GAMES. The head band will read my 'brain waves' to create a BASE LINE of my personal metrics at the start point of all readings. I'm told the original set of tests  (through brain games) was reduced  from 40 minutes  to 10 minutes, which is much less painful  (undergoing 40 minutes of challenging brain games may just be too much for the many impatient people and those with potential head injuries or cognitive disorders.  These games offer 3‐5 sets of memory and focus challenges like staring at an X for 3 Minutes, or remembering a combination of letters and numbers under a limited time.  



ACTIVITY STUDIES
I give the APP developers an A for this page‐ offering initial forms of activity. Listed are the typical actions  that brain health is to be studied/scanned by the Neurovine device.  The standard list given steers you to target these specific work types, while allowing you to add new ones that also expel brain energy. 

PREFLIGHT ANXIETY: (Personal base line data collecting) I took on the Neurovine experience as any other head patient of a physiatrist or neurologist, whereby I was to undergo an EEG exam. Simulating this has some elevation in stress or anxiety with these brain games, which I was concerned may affect its accuracy and ultimate  results. My instructor  (Yvonne)  reassured me  that any distractions are actually calculated with the AI and that the data I collect will have the propensity to auto‐adjust itself to find my median. (God bless AI)  

WEARABLE COMFORT: The  device is fairly comfortable and workable for daily life use, making  the  'art'  of  collecting cognitive biometrics fairly stress-free.  After a minute or so, you won't even know it's on. It feels just like any other sports headband or baseball cap where the contact points do not feel like anything. The APP showed default activities to choose from (like driving, computer work, listening to music etc) and you can add to them at will. As a personal device, I'll be collecting enough metrics in no time.  




OBSERVATIONAL REVIEW 

(NEUROVINE Start Date: 11/9/2022 By: Lennard M. Gettz, Ed.D 

11/25- Day 8 of my review journey with the portable product NeuroVine.  This experience is helping me claim my rightful mantle as a publisher of something called HealthTech Reporter‐ where I need to remain consistent with my project, looking to challenge or support the claims set by the manufacturer’s marketing. If my goal (in fact( is to be a public service and non‐invasive tech advocate, remaining unbiased challenger must remain my position. 

LANDMARK #5‐ I continue to ‘enjoy’ the functions of the headband/app system.  For those who have head injuries or are looking to study their brain waves for cognitive pacing, the friendliness of the device’s design feels like it would survive long‐term daily use.   As the review duration progresses, I sought out any critiques and minor kinks within the product, and I am grateful to be part of their R&D.  I have a separate WISH LIST when using the product inspires good ideas for possible UPRAGES.  

LEARNING ABOUT MY BRAIN PHYSIOLOGY
The EEG output was astonishing to find the difference in graphic reporting.  Today, I conducted a dual test: One NV screening was during my drafting work of a proposal (L Image), and the second task was (Right Image) sending an email intro  to prospective clients.  Drafting a proposal  from scratch clearly  required  true brain capacity‐ and the stress of that was obvious. This effort took 17:16 mins and according to the session summary, left me with 0% brain energy.  If elevated or erratic spikes on a graph was indicative of activity, the NV report certainly showed this.   

The  2nd  scan,  where  most  of  my  work  was  copy pasting  an  introductory  email  to  CEO’s  and developers  as  significantly  less  brain  work  (other than  personalizing  the  letter  and  sending  to  the proper  contact.    It  took  up  only  15%  of  my  brain energy capacity within a shorter period of time (8:52) and left me with 85% remaining brain energy. 

a) The increasing elevation of Brain Exertion told me that creative and administrative tasks combined with the observed STRESS/ANXIETY of doing it right makes for evident rise‐and‐drop of this energy. 

b) An added exertion in  the brain  (observed) is  the irritating distraction and the struggle to stay focused when  people around me were walking around and interrupting. To bring oneself back to focus is something I find to be exertive, as I gather was the added reason for the highest spikes on scan 1. Whereby Scan 2 was much more tacit due to no interruptions and interacting with anyone. 


COGNITIVE PACING:
According to the manual, “Cognitive pacing relates to activities requiring mental energy, like reading, learning of focusing… it is a strategy of modifying these activities so they're easier to perform (progressively), while gradually increasing the level of effort given to them.”  I can see the value in this for someone recovering from head trauma and the device is truly designed for this with repeated use for specific activities. 

As a review of the APP itself, the “parenting” factor of this technology was supposed to be about PACING and this is where it most likely comes in. An astounding drop in my brain energy appears on  the  final screen when I concluded my session  today. Starting at a complete and fully BLUE brain, the endpoint showed an illustration of the Brain showing a RED, DEPLETED GRAPH, indicating high brain strain‐ reporting below the fatigue threshold level.  If anything RED is a mark of some form of danger or an alert to do something, this clearly communicated this.  An ALL CAPS command to “TAKE A BRAIN BREAK” appears on the top of the screen to further enforce this. 

Assessment 1:
I used to wonder why the producers never made a wired device (for assumed best performance of a consistent energy feed).  For anyone having cognitive issues or is under observation by a clinician, such reporting  functions offer  that level  of utility during life  functions  (which is  the value of a portable, wearable device).  Having a device like this (and others like the Pedometer, the Pulse Oximeter or the FitBit*) work best DURING active mode, where the collection of biometrics is at its highest and most detectible. 


PART 3: DAILY LIFE ACTIVITIES

ACTIVITY TEST: DRIVING
Captain's Log... 12/23/2022 -  I finally found the time to test drive the Neurovine while DRIVING. As one of the main activity choices in the APP, I find driving to be one activity where the brain truly needs monitoring.  This activity spans ALL energy reports- from ZONING OUT on a long stretch of  highways to that sudden high BRAIN SPIKE when someone cuts you off to intermittent anxiety when you miss an exit.  The highest brain exertion is when I left the highway 30% into the review and  I found myself cutting through private streets and some medium traffic areas where I actually needed to pay more attention.  

I made sure to turn off the radio and my cell phone to conduct a full read of the driving experience. After 15.44 min, I found myself to have depleted significant brain energy, reduced from 100% to 11%.  This may be telling of a brain health condition or that driving is more stressful (or brain exhaustive) that I expected.


READING
12/23/2022 -  To confess, I have a growing stack of  books on my desk for that fateful day when I can catch up to my reading.  I dedicated 30 minutes to this test but the APP had other intentions.  Within 17.27 minutes, my brain was apparently exhausted and the program shut down with a warning to calm the mind.  I can attribute this to too much screen time and lack of work in that part of the imaginative brain that processes words into visuals.



RELAXATION SPELLS


12/31- I tried a variety of spellbinding zone activities around the home. As part of my intention to test the accuracy of the EEG sensory headband, I anticipated similarities between each scan, while identifying the minute differences of each experience- mainly how I interact with each of them. Comparatively, the EEG lines turned out to generate sensible differences.  





We all know about the calming power of GAZING at slow moving and floating objects.  I takes our minds off of stressful, over-exertive thoughts.  These find relaxation visuals allow us to follow things that move at a slower pace and with less effort on the eyes- bringing us into this hypnotic state. For this, I chose my aquarium and a lava lamp to explore the rest state of my brain.  Within a five minute period, I found both EEG graphs to register a fairly smooth and rounded lines- both starting at fairly elevated levels then gradually descending to the lowest exertion readings. Where high action readings show sharp, erratic up-and-down readings, both of these tests indicated un-dramatic movements- identifying limited cerebral demands. 

Within this same exercise, I chose a third relaxation activity- the fireplace. Here, I chose to keep my eyes un-fixated in any one area. I found my eyes bouncing around from the burning woods to the  random flickering tips of the flames.  The random yet pleasant crackling sounds also added to the information for the brain.  To my surprise, this text showed the least amount of variability. The slow plummet showed an immediate gliding descent to an almost flat line- indicating an almost completely RESTED brain by 40% of the event. A slight incline occurred by 80% of the event when I started moving around my seat, breaking the spell that a burning fire has apparently provided.  Lastly, if sensory intake affects brain activity, I could also attribute the HEAT as an added influence to pulling me into that deep rested (flat lined) state.



INTEGRATING (STACKING) MULTIPLE HEALTH TECHNOLOGIES
While undergoing microcirculation therapy of a muscle relaxing device called AVACEN, I found this to be a great opportunity to review brain waves and the parasympathetic response. 7:38  minutes  in the treatment showed a unique look to the EEG lines. Unlike the other up & down readings, the Avacen experience shows slow, rounded peaks.  I find this unusual because of the gradual slowness of the pulse waves rising and descending. This is indicative of the theorized philosophy of how such devices (including Pulse Electromagnetic Stimulation, Biofeedback etc) behave.  Another theory my clinical team and I have is that the  wave PATTERNS (behavior of my brain exertion) appear to have an even pace of up-to-down- pursuing a pattern that aligns with an eventual reduction in elevation- thus as time goes on, the highs and lows become reduced and the wave line settles toward the midpoint.  As this is only the beginning (1st day with Avacen), I aim to do continued studies with this device through NV as well as other therapeutic technologies that may offer such biometric readings.




STACKING (PART 2)- THE BRAINTAP (MEDITATIONAL DEVICE) TEST

This device reviewed shall undergo a Level 1 study (observational evaluation, biometric analysis from clinical imaging) of a device promoted as a portable relaxation and wearable meditation technology.  Commercially branded as BrainTap®, the device is designed to “address high stress, difficulty sleeping, low energy, and other lifestyle challenges”. By this, our evaluation partnership between members of IPHA (Integrative Pain Healers Alliance) and the Bard Diagnostic Imaging Center (NYC) joined to test drive/demo this and other technologies under a multi-modality review project as outlined below.
a. Evaluation on meditation effects on the body
b. Assessment and comments on the device's components (as stated in its user literature)
  - binaural beats, isochronic tones, holographic music
  - red and blue light / frequency therapy
c. Evaluation of the theories behind the device's design. Discussion on the variety of ways of boosting brain levels of serotonin, beta-endorphins and norepinephrine (as per the mentions of this device in social media, from other users blogs, literature and videos)





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