Tuesday, May 11, 2021
A Florida trial court has denied a defendant’s Daubert motion to strike the plaintiff’s expert’s testimony regarding qEEG testing. In Snyder v. ESURANCE Property and Casualty Insurance Company, Case No. 01-2018-CA-2651 (8th Judicial Circ. Ala. Chua. Cty., FL), the defendant sought to bar the testimony of Dr. Lisa Avery, an eligible board neurologist, from testifying regarding her interpretation of a quantitative electroencephalogram (qEEG). To support its motion, the defendant submitted “only” three articles and argued at a hearing that using qEEG for diagnosing mild traumatic brain injury had been prohibited by the American Academy of Neurology (AAN) for over 20 years. Noteworthy in the court’s opinion was that the AAN guideline relied upon by the defense was “retired” in January 2020 and was no longer the official position of the Academy.
The defendant presented two expert witnesses: Dr. Mary Schriver, a board- certified neurologist with a sub-specialty in neurophysiology, and Dr. Jason Demery, a board-certified neuropsychologist. While Dr. Schriver testified that she did not believe qEEG was a valid test for the diagnosis of traumatic brain injury, she did acknowledge that other doctors did use the test for that purpose. During the cross-examination, the plaintiff demonstrated that Dr. Schriver was unfamiliar with the software utilized by Dr. Avery, who was not an expert in interpreting it, and did not examine the raw data generated by the qEEG.
Dr. Demery also admitted that he was not qualified to administer or utilize a qEEG, nor was he an expert in qEEG in general. Dr. Demery disputed some findings in the numerous peer reviewed articles submitted by the plaintiff and raised false positives due to sleep apnea or medication, but did not produce, cite or reference any additional peer reviewed articles to support his position.
Contrasting the defendant’s presentation, the plaintiff submitted numerous peer-reviewed articles comprising over 140 pages, including book chapters and scientific journals supporting the use of qEEG in TBI diagnosis. The peer-review literature produced by the plaintiff denied the error rate argument supported by the defendant and established the wide-spread use of qEEG in diagnosing traumatic brain injury throughout the VA Hospital system. The plaintiff’s experts, Dr. Avery and Dr. Richard Boehme, M.D., testified that they used qEEG in their everyday practices and were familiar with the literature and its use. Due to their clinical experience, the court found the plaintiff’s witnesses to be persuasive.
After the court conducted a Daubert analysis, they found Dr. Avery was qualified, her testimony was based upon sufficient facts and data, and that utilizing qEEG as a tool to help diagnose traumatic brain injury was sufficiently reliable, scientific, and valid. The court also found that Dr. Avery reliably applied the qEEG to the specific case before it.
The court found that the case law presented by the defendant was not controlling as the cases cited were decided before the retirement of the AAN position and most were decided under a Frye standard. Based on the evidence offered at two hearings, the court concluded that qEEG testing related to traumatic brain injury was reliable and scientific when used with other tests or data, rejecting and denying defendant’s motion to strike.
Hard to imagine how anyone who understands what it must've been like to be working at Ground Zero on and after 9/11 could think there weren't going to be physical and mental consequences for the workers and survivors of that tragedy. No one should forget the chaos that followed in terms of people struggling to find survivors and the horror that they all endured in the process. It should not then surprise anyone that 20 years later we are witnessing the mental and emotional devastation that typically appears when people are in their 70s and 80s now is clearly evident in these folks in their 50s. The level of toxicity they were exposed to in a matter of days or weeks, most people never come close to in a lifetime.
Our work with people strugging with memory loss has taught us to look to the lifestyle and levels of exposure to black mold and other neurotoxins as well as being infected with spirochetes from tick bites. We also looked to the trauma that they endured in their lives from sexual and physical abuse, chronic pain and respiratory challenges as well as addiction to substances or disordered eating. The mismanagement of emotional stress challenges our immune system along with every other functional system in our body. How would that not add to the degrading our capacity to maintain a healthy internal biological and psychological ecosystem?
The report now about first responders developing early onset dementia comes as no surprise to me or anyone in my professional circle and it offers cold comfort to see these things coming and know there's very little attention being given let alone resources put toward mitigation of the downside risk and the inevitable disaster facing these brave souls who put their lives on the line for us every day. Grief over the enormity of the loss we suffered and that which was yet to come turned to anger shortly after the towers fell and it was clear that precious little attention being paid to the long term impact of being on the pile. The shocking enormity of the moment constrained most of our thinking to short term problem solving, coping with the next moment and the next. The axiom of those in recovery from addiction became the mantra for the country... 'one day at a time.'
There are tools available to these people to help them deal with their symptoms and possibly reverse their conditions or at least change the slope of decline. We've shown this to be true in our research on the use of self-administered transcranial infrared photobiomodulation (light therapy) and brainwave biofeedback. We are ready to help these heros first by letting them know that there is hope for recovery and the truth that time is the enemy in this situation. The sooner you start treatment the greater the chances are for improvement. Put the resources behind noninvasive technologies that have been proven effective in gold standard clinical trirals, that have no side effects, are easily deployed and would cost a fraction of what has been spent on the 500+ failed pharmaceutical trials in the vain search for a single molecule solution to a systemic disease. Researchers like Tom Lewis PhD (healthrevivalpartners.com) and Dale Bredesen (apollohealthco.com) foundational work has shown us there are alternatives to treating dementia, let's put them to work now for these brave souls who deserve nothing less than our absolute best.
Recent reports out of the recent Alzheimer's Association International Conference from researchers at NYU's Grossman School of Medicine showed evidence of a strong correlation between COVID 19 infection and acceleration of Alzheimer's disease pathology onset. They found that the patients admitted to the hospital for COVID 19 with neurologic events were largely (51%) diagnosed with toxic metabolic encephalopathy (TME) consisting mainly of septic and hypoxic ischemia. More than 50% of all subjects in the study who were followed for 6 months developed impaired cognitive functioning that diminished their ability to perform activities of daily living. However, the subjects who were followed who had been diagnsoed with COVID 19 were twice as functionally compromised when compared to the control sample.
The study also identified a number of plasma biomarkers associated with neuronal injury and dementia that were elevated in the COVID 19 cohort compared with controls. One measure in particular was Aβ42 which were significantly lower in the plasma which suggests increased levels would be found in the brain. This protein is shown to be elevated in people diagnosed with Alzheimer's and increases in line with disease progression.
It is therefore worth noting that early animal research conducted at Durham University on the use of 1070nm pulsed infrared light stimulation noted marked decreases in Aβ42 found after photobiomodulation treatment. (Grillo,2013). This combined with the recent evidence (Nizmutdinov,etal, 2021) of significant functional improvement in cognitive, behavioral and motor symptoms following 60 days of brief, twice-daily, self-administered 1070nm pulsed PBM therapy, It would not seem very unreasonable then to assume that intensive transcranial 1070nm photobiomodulation therapy could be useful in mitigation of neurological sequelae from COVID 19 infection.
Grillo,SL, Duggett NA, Ennaceur A, Chazot PL. Non-invasive infrared therapy (1072 nm) reduces β-amyloid protein levels in the brain of an Alzheimer's disease mouse model, TASTPM. J Photochem Photobiol B. 2013 Jun 5;123:13-22. doi: 10.1016/j.jphotobiol.2013.02.015.
Transcranial Near Infrared Light Stimulations Improve Cognition in Patients with Dementia.
Nizamutdinov, D, Qi, X, Berman,MH, Dougal, G, Dayawansa, S, Wu,X, Yi, S, Stevens, AB, Huang, JH. Aging and Disease, Volume 12, Number 5, June, 2021.
View article from Medscape here: www.medscape.com/viewarticle/955755?
The latest report from British Medical Journal reporters who investigated the FDA accelerated action program are showing that more than 2 in 5 drugs are not meeting the expectations for efficacy and quality. Maybe its time to consider alternative therapeutic models, especially for dementia and other neurodegenerative conditions that don't involve pharmaceuticals and can be self-administered at home by patients and their caregivers. Quietmind is working to engage in a comprehensive trial that will demonstrate the safety, reliability and efficacy of transcranial near infrared light therapy (tPBM) combined with brainwave biofeedback training. We've shown in expanded feasibility trials of tPBM conducted through Baylor Research Institute and Quietmind Foundation and our 15 years of clinical practice these tools are safe and rapidly effective in modifying cognitive and behavioral symptoms of dementia.
We hope to apply for accelerated action approval so that these therapies can be accepted and covered by Medicare and other insurances in the near future. Now, we are making the tPBM units available as wellness oriented interventions to support relaxation and improve over
Click here for article: www.medscape.com/
The latest review of Aducanumab (Aduhelm), the recently FDA approved medication for Alzheimer's, has been determined to have 'Zero Benefit' as determined by the California Technology Assessment Forum in a recent report to the Institute for Clinical and Economic Review (ICER). The stunningly depressing and ironic fact is that the report decries the lack of effective medications for Alzheimer's while not considering supporting treatment alternatives, e.g., transcranial infrared photobiomodulation, that have published clinical efficacy in reversing both cognitive and behavioral symptoms in subjects diagnosed with mild to moderate dementia.
Hopefully more people will recognize that there are options available to influence the slope of decline as well as taking steps to prevent disease onset using what are considered 'alternative' approaches like those advocated by Dale Bredesen and Apollo Health (https://www.apollohealthco.com/). Quietmind Foundation is proud to have been invited to partner with Apollo Health in advocating for the development of noninvasive, non-drug treatment protocols for Alzheimer's and other neurodegenerative disorders.
Link to the Medscape article: zero benefit to dementia patients while costing $56,000/yr.
The new drug from Biogen carries a very hefty price tag along with a very limited level of efficacy that has now been further limited by recent FDA labeling guidelines. The drug that costs $56,000 a year and is delivered intravenously is designed to flatten the slope of cognitive decline and will not reverse memory loss, behavioral challenges or other functional deficits.
The irony is not lost on us that transcranial infrared photobiomodulation, a treatment for which there is published evidence of reversal of memory, mood and motor symptoms and costing less than $4000, has not been afforded much recognition within the mainstream Alzheimer's treatment community. We are hopeful this will changes as clinicians like Dr. Dale Bredesen recognize and advocate for the use of this technology in the treatment of neurodegenerative disorders.
Quietmind Foundation has been selected to partner with Dr. Bredesen's company Apollo Health to provide consultation and training in the clinical use of photobiomodulation with their practitioners and patients. We are excited by this important opportunity and look forward to working with this community of providers and consumers and hope the word will spread and more people will be able to take advantage of this important neurophysiological health resource.
Alzheimer’s was first identified in 1906. Over a hundred years later, there's still no curative treatment for the disease. What we do have are potential procedures, lifestyle changes, and medications that help slow down its progression. Just recently, the Food and Drug Administration (FDA) approved a new Alzheimer’s drug, Aduhelm. And it’s been met with a lot of mixed reactions from the scientific community. To get FDA approval, drugs must go through two Phase III trials with positive results. Aduhelm skipped both and only presented preliminary results. It’s one of the first few drugs specifically made for Alzheimer’s; bypassing the processes may set a negative precedent for further research and trials. It creates more doubt and disagreements within the scientific community and mistrust among the general public.
There’s no space for dubious processes in Alzheimer’s treatment research, not when there are a number of other roadblocks to overcome.
Lack of Funding
A study conducted by the Rush Alzheimer’s Disease Center found that Alzheimer’s-related deaths are now nearly on par with cancer deaths, claiming 500,000 lives annually. Despite that, research funding for Alzheimer’s ($550 million) doesn’t even come close to half of the funds dedicated to cancer research ($5.7 billion). In fact, many research teams have had to turn to private funding and seek out donations to continue their studies on non-drug Alzheimer’s treatment. This isn’t to minimize the severity of cancer – it still is a serious and debilitating disease – but considering how Alzheimer’s is just as pervasive, it should also be prioritized.
From a macro perspective, the U.S. ranks low in elderly care among other rich countries. Perhaps since Alzheimer’s is perceived more as a condition of the elderly, it’s not given much importance. The study highlighted how dire the need is for government and systemic support. In response to the worrying figures, Alzheimer’s advocates have called for a sense of urgency from the government. They pointed out that without swift action and effective treatment, Alzheimer’s-related deaths will continue to rise. It’s a condition that’s just as life threatening as cancer and there should be more support in finding cures.
A compounding effect of the lack of funding is the lack of knowledge about Alzheimer’s disease. While there’s a general understanding that Alzheimer’s is linked to the plaque formation of beta-amyloid in the brain, researchers are still debating whether it’s a cause or a symptom of the disease – this is a concern since these plaques are used as biomarkers of Alzheimer's.
What’s more, there’s a disproportionate standard of imaging and non-imaging biomarkers. Doctors generally rely on lab tests, scans, and exams to evaluate the symptoms of the disease. But there’s a need to advance non-imaging biomarkers since the condition is difficult to confirm based on imaging diagnostics alone. There are behavioral and cognitive biomarkers that need to be studied and determined. It's only when these theories are substantiated that effective treatment can be made.
Studies on Alzheimer’s have been dominantly focused within the neuroscientific field. This means that only a select few are regarded as authorities on the subject. However, that’s been challenged in the modern interdisciplinary research environment. Professionals from different disciplines need to have access and opportunity to spur on Alzheimer’s research.
Today, many healthcare and research professionals are pursuing continuing education and exploring specialties in cognitive sciences, particularly through online institutions that allow them to study and maintain their careers. This is evident in online MSN degrees, in particular, which lead nurses to more advanced practice specializations. These degree-holders are taught to take a holistic approach, providing both medical care and assistance in making lifestyle choices as well. This makes them valuable assets to Alzheimer’s research, especially as we begin to see the condition beyond just the medical lens. Moreover, research for Alzheimer’s treatment should run the gamut from a range of biomedical science perspectives – or even those with training in engineering and computational science – to speed the process along. Expertise in neuroscience alone can only take treatment discovery so far.
Treatment Options Focused on Pharmacology
Despite the growing body of published clinical evidence that the symptoms of Alzheimer’s and other dementias can be treated and in some cases prevented – by lifestyle change, photobiomodulation, neurofeedback training and functional medicine, many healthcare professionals still insist on single molecule pharmacology. This is due, in part, to the skewed credence given to traditional allopathic neurologists who staunchly advocate for medications and invasive therapies. Much like all new views in medicine, new ideas are often initially met with resistance and overcoming resistance takes time to educate physicians and relentless patient advocacy that allow people to make new choices for their loved ones and themselves.
As it is, medical institutions can barely service the demand. Home-based, self-administered, systemically-oriented treatment solutions that are safe, affordable and grounded in rigorous scientific evidence are what is needed. One such solution is the RECODE protocol advanced by Dr. Dale Bredesen. It’s essentially a lifestyle modification method that aims to delay or protect against neurodegeneration. The protocol suggests targeting and improving 36 lifestyle factors that have been shown to contribute to cognitive decline. The protocol advocates for removal of systemic toxins include heavy metals, mold and other environmental pathogens, regular aerobic exercise, and intermittent fasting and a Mediterranean diet. Dr. Bredesen and his colleagues at Apollo Health strongly support the idea that dementia is the result of long term systemic inflammation and that changes of the kind he suggests can enhance cognitive function and reverse decline at any age. Recent dialogue between Quietmind Foundation President Marvin Berman and Dr. Bredesen (Bredesen Facebook Live have shown how closely their ideas and practices are aligned and future combined trials have been mentioned.
Given the support and chance to grow, many non-invasive and non-pharmacological methods could be discovered to treat Alzheimer’s. These could be game-changing for both patients and the healthcare system. These types of treatments would allow Alzheimer’s patients to require less inpatient care, letting them continue treatment at home.
Even if there are a number of roadblocks, there’s still much hope for a safe, effective and affordable Alzheimer’s treatment. Recognizing these challenges is the first step in overcoming these hurdles.
This article was prepared especially for www.quietmindfdn.org by Alice Palmer
Combining Photobiomodulation and Neurofeedback and Functional Medicine with Dale Bredesen, MD and Julie Gregory
I was extremely pleased to be interviewed by Dr. Dale Bredesen and Julie Gregory on Dr. Bredesen's Facebook Live channel on Thursday.
We covered a range of topics related to the mechanisms of action of infrared light photobiomodulation (PBM) and other forms of non-invasive stimulation, neurofeedback training and how these safe, reliable, affordable technologies can enhance the effectiveness of functional medicine as a treatment model for neurodegenerative conditions. This will hopefully be viewed those patients and clinicians who have trained and are affiliated with Apollo Health in order to expand the availability of these types of home-based, low-cost, non-drug, noninvasive treatment options for people seeking to stop or prevent cognitive and functional decline.
We will post the full transcript of the program along with additional links to information discussed in the program and some discount codes for purchasing the light therapy devices. I'm quite keen to see how we can put together a trial that will combine RECODE, PBM and neurofeedback.
Researchers are now able to report that the COVID 19 virus has the ability to cause small vessel damage to the brain tissue itself and not impair neuronal activity as was previously thought. The key point was made by the study author, Anna Cervantes, MD "Even though most of the coagulopathy is largely venous and probably microvascular, this does affect the brain through a myriad of ways". Our efforts to encourage the use of photobiomodulation are rooted in the knowledge that inflammatory processes include microvasular occlusion resulting in hypoperfusion. These are the fundamental hallmarks for all neurodegenerative disorders and why we advocate so strongly for taking prophylactic steps now to protect our brain with near infrared stimulation and functional medicine to reduce or hopefully remove neurotoxicity.
The combined approach of photobiomodulation and neurofeedback has proven to be of considerable benefit to many patients who needed to feel a sense of hope and control over their condition which is a key part of the integrative health model at QMF.
The list of symptoms that are now being seen to have links to COVID 19 infection are growing especially in the area of neurological and neuropsychiatric conditions. I think we are going to be seeing a large increase in people reporting these kinds of problems over the coming months and years and neurologists and mental health professionals are going to need all the tools they can muster to help their patients recover.
One very recently reported area of dysfunction is the brainstem which controls many basic life functions, include respiration, cardiovascular, gastrointestinal functions and neurological functions. We must be vigilant about making sure that the brain is protected against further injury from the COVID virus which can attack areas around the brain while not necessarily attacking the brain itself. Photobiomodulation is a way to treat the brain tissue that can provide protection against future injury while boosting the resources that are needed to help heal and improve overall brain functions.
Read the article here: https://pubmed.ncbi.nlm.nih.gov/33538586/
Our team regularly publishes articles and blog posts on the latest research and news coming out of our group and the field in general.